<h5 class="wp-block-heading" id="h-fda-now-recommends-genetic-testing-before-prescribing-specific-chemotherapy-medications">FDA Now Recommends Genetic Testing Before Prescribing Specific Chemotherapy Medications</h5>



For years, patient advocates have been calling for stronger safeguards against preventable toxicity from chemotherapy. Last week, the FDA took a major step forward, updating the label for a drug called <a href="https://medlineplus.gov/druginfo/meds/a699003.html" target="_blank" rel="noreferrer noopener">capecitabine</a> to explicitly recommend testing for variants in the DPYD gene before starting treatment. This is more than just a label change—it&#8217;s a long-awaited acknowledgment that genetics matter when it comes to patient safety.



<h2 class="wp-block-heading">What is DPYD?</h2>



The <a href="https://medlineplus.gov/genetics/gene/dpyd/" target="_blank" rel="noreferrer noopener">DPYD gene</a> provides instructions for making an enzyme called DPD (dihydropyrimidine dehydrogenase), which helps the body break down certain chemotherapy drugs like capecitabine and <a href="https://medlineplus.gov/druginfo/meds/a682708.html" target="_blank" rel="noreferrer noopener">5-fluorouracil</a>. These medications are commonly used to treat breast, colorectal, and other cancers. People with certain changes in this gene may not process these drugs properly, causing the drugs to build up in the body and, in some cases, leading to severe or even life-threatening <a href="https://medlineplus.gov/genetics/condition/dihydropyrimidine-dehydrogenase-deficiency/" target="_blank" rel="noreferrer noopener">reactions</a>.



<figure class="wp-block-image alignleft size-full is-resized"><img loading="lazy" decoding="async" width="508" height="531" src="http://35.88.189.111/wp-content/uploads/2025/10/drug-bottle.png" alt="" class="wp-image-34304" style="width:126px;height:auto" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2025/10/drug-bottle.png 508w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2025/10/drug-bottle-287x300.png 287w" sizes="auto, (max-width: 508px) 100vw, 508px" /></figure>



These reactions can include painful mouth sores, severe diarrhea, low white blood cell counts, and nerve problems. <a href="https://medlineplus.gov/genetics/condition/dihydropyrimidine-dehydrogenase-deficiency/#frequency" target="_blank" rel="noreferrer noopener">Up to 8%</a> of people have a variant in the DPYD gene that affects how well they process these medications. Sadly, some patients with DPYD variants have died after receiving these drugs. Such experiences have fueled years of advocacy calling for genetic testing before treatment, not after. 



<h2 class="wp-block-heading" id="h-a-change-in-the-recommendations">A change in the recommendations</h2>



Until now, the FDA advised doctors they could &#8220;consider testing&#8221; patients before giving capecitabine or similar drugs. The <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020896s052lbl.pdf" target="_blank" rel="noreferrer noopener">new label</a> goes much further, adding a warning that says, &#8220;serious adverse reactions or death may occur in patients with complete DPD deficiency&#8221; and telling doctors to test for DPYD variants before prescribing the medication. (Experts predict a similar change to the 5-fluorouracil drug label soon.) It&#8217;s a major win for patient safety and for the <a href="https://test4dpd.org/" target="_blank" rel="noreferrer noopener">advocacy groups</a> who have pushed tirelessly for this change. Organizations that have long advocated for universal DPYD testing hope this update will encourage hospitals and cancer centers across the U.S. to make pretreatment genetic testing standard care.



<figure class="wp-block-image alignright size-large is-resized"><img loading="lazy" decoding="async" width="790" height="1024" src="http://35.88.189.111/wp-content/uploads/2020/09/PGt-Home-790x1024.png" alt="23andMe mobile pharmacogenomics" class="wp-image-28527" style="width:256px;height:auto" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home-790x1024.png 790w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home-231x300.png 231w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home-768x996.png 768w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home-679x880.png 679w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home-910x1180.png 910w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home.png 1583w" sizes="auto, (max-width: 790px) 100vw, 790px" /></figure>



We share the belief that genetic insights can empower individuals and help improve outcomes. The 23andMe® <a href="https://www.23andme.com/topics/pharmacogenetics/dpyd/" target="_blank" rel="noreferrer noopener">DPYD Drug Metabolism Pharmacogenetics report</a>*, available to <a href="https://www.23andme.com/membership/" target="_blank" rel="noreferrer noopener">23andMe+ Premium</a>™ members, provides information about two variants associated with reduced DPD enzyme activity. While this report isn&#8217;t a substitute for clinical testing, it can help people learn whether they carry certain DPYD variants and start a conversation with their healthcare provider. 



The FDA&#8217;s new label is an important step toward safer, more personalized cancer treatment and a long-awaited victory for the patients and advocates who made their voices heard.



<hr class="wp-block-separator has-alpha-channel-opacity"/>



 * 23andMe PGS Pharmacogenetics reports: The 23andMe test uses qualitative genotyping to detect 3 variants in the CYP2C19 gene, 2 variants in the DPYD gene and 1 variant in the SLCO1B1 gene in the genomic DNA of adults from saliva for the purpose of reporting and interpreting information about the processing of certain therapeutics to inform discussions with a healthcare professional. It does not describe if a person will or will not respond to a particular therapeutic. Our CYP2C19 Pharmacogenetics report provides certain information about variants associated with metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of citalopram and clopidogrel therapy. Our SLCO1B1 Pharmacogenetics report provides certain information about variants associated with the processing of some therapeutics and provides interpretive drug information regarding the potential effect of simvastatin therapy. Our DPYD Pharmacogenetics report does not describe the association between detected variants and any specific therapeutic. Results for DPYD and certain CYP2C19 results should be confirmed by an independent genetic test prescribed by your own healthcare provider before taking any medical action. Warning: Test information should not be used to start, stop, or change any course of treatment and does not test for all possible variants that may affect metabolism or protein function. The PGS test is not a substitute for visits to a healthcare professional. Making changes to your current regimen can lead to harmful side effects or reduced intended benefits of your medication, therefore consult with your healthcare professional before taking any medical action. For important information and limitations regarding Pharmacogenetic reports, visit <a href="http://23andme.com/test-info/pharmacogenetics/" target="_blank" rel="noreferrer noopener">23andme.com/test-info/pharmacogenetics/</a>

A Big Step Forward for Patient Safety

Common medications for conditions like anxiety, depression, or high cholesterol or even to limit the growth of some cancers, may not work as well for some of us because of our genetics.



Yet few of us know before we are prescribed an SSRI for depression, say, or a statin for high cholesterol, that we have a genetic variant that may impact how our bodies process those medications.



What if you and your doctor knew this beforehand?



<h2 class="wp-block-heading" id="h-open-your-genetic-medicine-cabinet">Open Your (Genetic) Medicine Cabinet</h2>



This week, we launched an upgrade to Medicine Cabinet, a feature for 23andMe+ Premium members that allows them to more simply check how their genetics may impact the medications they are currently taking.*



This version of the feature is also another way customers learn more about genetics&#8217; role in processing certain medications.* Most people have at least one genetic variant that may alter how their bodies process certain commonly prescribed drugs.



<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="640" height="740" src="http://35.88.189.111/wp-content/uploads/2024/10/medCabinet-CommsBanner-640x740-1.jpg" alt="" class="wp-image-33443" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2024/10/medCabinet-CommsBanner-640x740-1.jpg 640w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2024/10/medCabinet-CommsBanner-640x740-1-259x300.jpg 259w" sizes="auto, (max-width: 640px) 100vw, 640px" /></figure>



<h2 class="wp-block-heading" id="h-what-is-pharmacogenetics">What is Pharmacogenetics?</h2>



The FDA lists<a href="https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations"> dozens of medications with &#8220;pharmacogenetic associations&#8221;</a> and continues to add more.&nbsp;



<a href="https://www.cdc.gov/genomics-and-health/about/pharmacogenetics.html">Pharmacogenetics</a> is the study of how single DNA variants affect how you respond to medication. While many of these <a href="https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations">pharmacogenetic associations</a> have been known for years, few people are tested before being prescribed many of these medications. 23andMe was the first direct-to-consumer genetics company to receive <a href="https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-direct-consumer-test-detecting-genetic-variants-may-be-associated-medication">FDA authorization for its Pharmacogenetic Report</a>s*.&nbsp;



23andMe&#8217;s Medicine Cabinet feature puts more information directly in customers&#8217; hands. It allows 23andMe+ Premium members to easily input the medications they&#8217;re using into the feature manually or, for iOS users, through Apple&#8217;s HealthKit and save that information. Based on their Pharmacogenetic reports, they are then alerted of possible DNA-medication interactions.



That way, customers can more proactively monitor additional medication insights over time, as their medication may change or other pharmacogenetic associations become more known.&nbsp;&nbsp;



Of course, genetics is just one factor that influences how you process medications. Other factors, like age, weight, liver and kidney function, drug interactions, or even some foods, also play a role.



<h2 class="wp-block-heading" id="h-23andme-s-pharmacogenetic-reports-nbsp">23andMe’s Pharmacogenetic Reports&nbsp;</h2>



Currently,<a href="https://www.23andme.com/test-info/pharmacogenetics/"> 23andMe&#8217;s Pharmacogenetic Reports</a> examine variants in three genes affecting how individuals metabolize or transport about two dozen medications.



For example, 23andMe offers reports that look at variants in the genes CYP2C19, DPYD, and SLCO1B1, which are involved in processing specific medications. The CYP2C19 enzyme helps metabolize many commonly used drugs, such as proton pump inhibitors, the antiplatelet clopidogrel, and certain antidepressants. The DPYD gene encodes the DPD enzyme, which helps break down fluoropyrimidine chemotherapy medications, including fluorouracil (5-FU) and capecitabine. The SLCO1B1 gene encodes the SLCO1B1 protein, which helps transport cholesterol-lowering statins into the liver for removal from the body.



Knowing your underlying genetics could help you and your doctor ensure the effectiveness of some of your prescribed medications.&nbsp;



<h2 class="wp-block-heading" id="h-learn-more">Learn More</h2>



Medicine Cabinet will help 23andMe+ Premium members more easily monitor those medications and provide updates on newly identified pharmacogenetic associations or additional 23andMe reports.



This version of Medicine Cabinet is available to 23andMe+ Premium members in the United States. Learn more about <a href="https://www.23andme.com/membership/">joining 23andMe+ Premium here</a>.



<hr class="wp-block-separator has-alpha-channel-opacity"/>



*23andMe PGS Pharmacogenetics reports: The 23andMe test uses qualitative genotyping to detect 3 variants in the CYP2C19 gene, 2 variants in the DPYD gene, and 1 variant in the SLCO1B1 gene in the genomic DNA of adults from saliva to report and interpret information about the processing of certain therapeutics to inform discussions with a healthcare professional. It does not describe if a person will or will not respond to a particular therapeutic. Our CYP2C19 Pharmacogenetics report provides certain information about variants associated with the metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of citalopram and clopidogrel therapy. Our SLCO1B1 Pharmacogenetics report provides certain information about variants associated with the processing of some therapeutics and provides interpretive drug information regarding the potential effect of simvastatin therapy. Our DPYD Pharmacogenetics report does not describe the association between detected variants and any specific therapeutic. Results for DPYD and certain CYP2C19 results should be confirmed by an independent genetic test prescribed by your own healthcare provider before taking any medical action. 



Warning: 



Test information should not be used to start, stop, or change any course of treatment and does not test for all possible variants that may affect metabolism or protein function. The PGS test is not a substitute for visits to a healthcare professional. Making changes to your current regimen can lead to harmful side effects or reduced intended benefits of your medication, therefore consult with your healthcare professional before taking any medical action. For important information and limitations regarding Pharmacogenetic reports, visit <a href="https://www.23andme.com/test-info/pharmacogenetics/">23andme.com/test-info/pharmacogenetics/</a>

Take a Peek Inside 23andMe’s Upgrade to the Medicine Cabinet Feature

Lillian Newman decided to use 23andMe in part because she wanted to learn about her grandfather, who was from Cuba and had some Sephardic ancestry, but she thought testing could reveal so much more than that.



&#8220;The reason I chose 23andMe is that (it has) a focus not only on the ancestry side but on how your DNA relates to your health,&#8221; Lillian said.



<h2 class="wp-block-heading" id="h-what-i-know-now">What I Know Now</h2>



<figure class="wp-block-image alignright size-medium"><img loading="lazy" decoding="async" width="225" height="300" src="http://35.88.189.111/wp-content/uploads/2024/08/IMG_3775-225x300.jpg" alt="A photo of Lillian Neuman" class="wp-image-33205" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2024/08/IMG_3775-225x300.jpg 225w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2024/08/IMG_3775-768x1024.jpg 768w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2024/08/IMG_3775-660x880.jpg 660w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2024/08/IMG_3775-885x1180.jpg 885w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2024/08/IMG_3775-scaled.jpg 1920w" sizes="auto, (max-width: 225px) 100vw, 225px" /></figure>



Little did she know that her 23andMe health reports would help her profoundly. She shared her story because she thought it might help others. Lillian believes that she&#8217;s not the only one who didn&#8217;t know that genetics affects how one&#8217;s body processes many commonly prescribed medications.* Despite this, clinical guidelines rarely call for testing people before prescribing those medications.



&#8220;I wish I had known then what I know now,&#8221; Lillian said. &#8220;Using 23andMe+ Premium and finding out about the SLCO1B1 gene was huge. Huge.&#8221;



Her reference to the SLCO1B1 gene refers to how different genetic variants in SLCO1B1 can affect how you process certain medications.&nbsp; Like millions of Americans, Lillian Newman has high cholesterol, which, left untreated, can lead to a whole host of issues, including heart disease, heart attacks, and strokes. She learned about her high cholesterol after a routine blood test in 2018. To address the problem, Lillian&#8217;s doctor prescribed a statin.



<h2 class="wp-block-heading" id="h-statins-save-lives">Statins Save Lives</h2>



Statins are among the most prescribed medications in the United States. According to the CDC, an estimated one in four adults in the U.S. takes a cholesterol-lowering medication, and the vast majority of those are statins.



Statins work by inhibiting an enzyme in the liver so the liver makes less cholesterol but pulls in more cholesterol from the bloodstream. That lowers the amount of bad cholesterol in the blood, stabilizing any plaques along the artery&#8217;s walls, and preventing even more plaque from building up. That, in turn, reduces the chances of a stroke or heart attack. Statins have proven<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5126440/"> mostly safe and effective</a> in lowering cholesterol and thus have helped to prevent heart attacks and strokes.



<h2 class="wp-block-heading" id="h-side-effects">Side Effects</h2>



But there are some side effects from taking statins — headache, brain fog, fatigue, and sometimes intense muscle cramping and pain. Sometimes, these side effects are related to a person&#8217;s genetics, which can affect how they process medications. In turn, the side effects sometimes lead people to either change how they take their medication or stop taking it altogether, which in turn can lead to poor health outcomes.



For Lillian, the side effects — severe muscle pain — began after her doctor increased the dose of the statin she was taking. Within a few weeks, the muscles in her legs started cramping. At one point, she had such crushing chest pain that she thought she was having a heart attack and was rushed to the ER. After a cardiologist determined it wasn&#8217;t her heart, her doctor told her that sometimes people experience cramping as a side effect of taking statins but that the benefits of taking the statin outweigh the pain.



&#8220;I remember I went home feeling despondent,&#8221; Lillian said.



Lillian said no one ever mentioned genetics or how using a different statin dose might help. She thought she just had to grit her teeth and bear it. Periodically, the pain was so bad that she&#8217;d go off her medication, something that can be very risky.



<h2 class="wp-block-heading" id="h-a-simple-change">A Simple Change</h2>



A person&#8217;s genetics — specifically a genetic variant that affects the function of the <a href="https://blog.23andme.com/articles/new-23andme-report-on-simvastatin">SLCO1B1 transporter protein</a>, which in turn affects how a person&#8217;s body processes the statin known as simvastatin — plays a role in side effects like muscle pain in some people. Other non-genetic factors also play a role, but very few people are tested to see if they have a genetic marker that might impact how they process a drug. Lillian didn&#8217;t know anything about what&#8217;s known as <a href="https://blog.23andme.com/articles/23andme-granted-the-first-and-only-fda-authorization-for-direct-to-consumer-pharmacogenetics-reports">pharmacogenetics</a> or how DNA variants influence the body&#8217;s ability to process medication.



&#8220;In the five years of dealing with cholesterol issues, no one tested me for SLC01B1,&#8221; Lillian said.



Although she had been a customer of 23andMe for years, last year, she decided to upgrade to 23andMe+ Premium, which includes pharmacogenetic reports. When she opened the report on SLCO1B1 Drug Transport, specifically looking at the medication insights for simvastatin, it felt personal to her experience.



&#8220;It provided me with critical information to discuss with my doctor,&#8221; Lillian said.



Her doctor lowered her statin dosage, and that small change made a huge difference in her life, allowing her to continue to manage her cholesterol but without the debilitating pain.&nbsp;



&#8220;Now, I wanted to tell you that doing the 23andMe+ membership is the best (money) I spent this year,&#8221; Lillian said. &#8220;I am deeply grateful to 23andMe. You truly made a difference for me by having that test available. I think everyone should know about this.&#8221;&nbsp;



<hr class="wp-block-separator has-alpha-channel-opacity"/>



<h2 class="wp-block-heading" id="h-note">Note:</h2>



*23andMe PGS Pharmacogenetics reports: The 23andMe test uses qualitative genotyping to detect 3 variants in the CYP2C19 gene, 2 variants in the DPYD gene, and 1 variant in the SLCO1B1 gene in the genomic DNA of adults from saliva to report and interpret information about the processing of certain therapeutics to inform discussions with a healthcare professional. It does not describe if a person will or will not respond to a particular therapeutic and does not describe the association between detected variants and any specific therapeutic. 



Our CYP2C19 Pharmacogenetics report provides certain information about variants associated with metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of citalopram and clopidogrel therapy. Results for SLCO1B1 and DPYD and certain CYP2C19 results should be confirmed by an independent genetic test prescribed by your own healthcare provider before taking any medical action. Warning: Test information should not be used to start, stop, or change any course of treatment and does not test for all possible variants that may affect metabolism or protein function. The PGS test is not a substitute for visits to a healthcare professional. Making changes to your current regimen can lead to harmful side effects or reduced intended benefits of your medication, therefore consult with your healthcare professional before taking any medical action. For important information and limitations regarding Pharmacogenetics reports, visit <a href="http://23andme.com/test-info/pharmacogenetics/">23andme.com/test-info/pharmacogenetics/</a>

Customer Learns Her Genetics Impacts How She Processes Statins

Genetics is a big reason why many millions of people respond differently to <a href="https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling">commonly prescribed medications</a>, and yet few of us are screened to detect these genetic differences.



This week 23andMe added another in a suite of reports that examine how a person&#8217;s genetics may impact their response to certain medications, and their chance of experiencing possible side effects. These are the first and only <a href="https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests#list">direct-to-consumer pharmacogenetic reports authorized by the FDA</a>.



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="416" src="http://35.88.189.111/wp-content/uploads/2023/07/enzyme.1b88dacdc77b-1024x416.png" alt="" class="wp-image-31976" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/enzyme.1b88dacdc77b-1024x416.png 1024w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/enzyme.1b88dacdc77b-300x122.png 300w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/enzyme.1b88dacdc77b-768x312.png 768w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/enzyme.1b88dacdc77b-880x357.png 880w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/enzyme.1b88dacdc77b-1180x479.png 1180w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/enzyme.1b88dacdc77b.png 1320w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></figure>



<h6 class="wp-block-heading" id="h-simvastatin-medication-insight-report-nbsp">Simvastatin Medication Insight report&nbsp;</h6>



The updated <a href="https://www.23andme.com/topics/pharmacogenetics/slco1b1/" target="_blank" rel="noreferrer noopener">Pharmacogenetics report for SLCO1B1 Drug Transport</a> with a new Medication Insight Report* is available for <a href="https://www.23andme.com/membership/">23andMe+ members</a>. It looks at how individuals respond to simvastatin, sold under the brand names Flolipid® and Zocor.® It provides an easy-to-read message telling them whether they have an increased chance of experiencing side effects. Simvastatin is a statin drug used to lower cholesterol in the blood and reduce the risk of heart attacks, strokes, or other heart problems.&nbsp;



<a href="https://pubmed.ncbi.nlm.nih.gov/30580575/">One in four Americans over 40 uses a statin</a> to lower their cholesterol, as reported by American Heart Association scientists. About 8 million people in the US were prescribed the statin simvastatin in 2020. This amounts to about 36 million prescriptions, making it among the <a href="https://clincalc.com/DrugStats/">most prescribed medications</a> in the United States, according to <a href="https://clincalc.com/DrugStats/About.aspx">ClinCalc DrugStats database</a>. ClinCalc provides prescription drug utilization data estimates for patients in the United States that is drawn from government sources including the NIH and FDA.



Genetic differences in the SLCO1B1 gene affect a protein involved in moving some medications, including statins, from the blood to the liver. The liver is where they are processed and removed from the body.



When the gene function is reduced, statin levels in the blood rise. This increases the likelihood of <a href="https://blog.23andme.com/articles/snpwatch-gene-variant-may-increase-risk-for-rare-side-effect-of-cholesterol-lowering-drugs">side effects like muscle pain</a>, weakness, or both, a condition known as myopathy.&nbsp;



<figure class="wp-block-image size-full"><img loading="lazy" decoding="async" width="579" height="325" src="http://35.88.189.111/wp-content/uploads/2023/07/SLCO1B1.png" alt="" class="wp-image-31979" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/SLCO1B1.png 579w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/SLCO1B1-300x168.png 300w" sizes="auto, (max-width: 579px) 100vw, 579px" /></figure>



Muscle pain or weakness is one of the most common side effects of statins, including simvastatin.&nbsp; About <a href="https://pubmed.ncbi.nlm.nih.gov/30580575/">one in ten people on statins</a> stop using them, according to a study from the American Heart Association.&nbsp; About 60 percent report of those who stopped said they <a href="https://pubmed.ncbi.nlm.nih.gov/22658145/">stopped because of muscle pain</a>, according to research by scientists at the St. Louis University School of Medicine. Having one or two copies of the SLCO1B1 variant included in 23andMe&#8217;s Pharmacogenetics report increases the <a href="https://pubmed.ncbi.nlm.nih.gov/32702748/">risk of developing simvastatin-associated myopathy from two to six times</a>. Importantly, studies have shown that patients who received SLCO1B1 genotype-guided therapy were <a href="https://pubmed.ncbi.nlm.nih.gov/25563221/">more likely to take their medication, had improved perceptions of statin therapy</a>, and had <a href="https://pubmed.ncbi.nlm.nih.gov/30354330/">better health outcomes</a>.&nbsp;



<h6 class="wp-block-heading">Drug Response</h6>



People respond differently to the same medicine due to many factors such as age, weight, liver and kidney function, diet, or even other drugs they might be taking. But we have also known for some time that for many medications, genetic differences also play a role in their effectiveness.



In some cases, those differences may also lead to adverse drug reactions.&nbsp;



<figure class="wp-block-image size-large"><img loading="lazy" decoding="async" width="1024" height="388" src="http://35.88.189.111/wp-content/uploads/2023/07/other_factors.a2fa6546eb5d-1024x388.png" alt="" class="wp-image-31980" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/other_factors.a2fa6546eb5d-1024x388.png 1024w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/other_factors.a2fa6546eb5d-300x114.png 300w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/other_factors.a2fa6546eb5d-768x291.png 768w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/other_factors.a2fa6546eb5d-880x333.png 880w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/other_factors.a2fa6546eb5d-1180x447.png 1180w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2023/07/other_factors.a2fa6546eb5d.png 1320w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></figure>



About half of the people in the United States use at least<a href="https://www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm"> one prescription drug</a> in any given month, according to data from the CDC. Millions of these individuals have one common genetic variant that impacts<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9177500/"> how they process those medications</a>. This could impact how they respond to a blood thinner, an antidepressant, or pain medication. The list of medications that the Food and Drug Administration labels with a known genetic variant that impacts their efficacy or chance for side effects now includes <a href="https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling">hundreds of drugs</a>. That list continues to grow. Knowing beforehand whether a prescription drug is likely to work, or trigger an adverse reaction, offers a tremendous public health benefit.



A recent European study involving almost 7,000 patients in seven European countries over three years noted the potential of using this information in care. It found that using genetic screening to identify people with variants that affected how they processed a medication lowered the risk of patients having an adverse drug reaction by<a href="https://upgx.eu/matching-medication-to-dna-leads-to-30-fewer-side-effects/"> 30 percent</a>. The study was led by U-PGx, a consortium of researchers from more than <a href="https://upgx.eu/u-pgx-consortium/">a dozen universities and research institutions in Europe and the UK</a>.



<h6 class="wp-block-heading">23andMe&#8217;s Pharmacogenetics Reports*</h6>



23andMe+ Membership includes information about how your <a href="https://www.23andme.com/test-info/pharmacogenetics/" target="_blank" rel="noreferrer noopener">DNA may affect the processing of almost two dozen medications</a>. Among them are drugs used in treatments that range from depression and high cholesterol, to certain medications used in chemotherapy. The reports examine how variants in three genes — <a href="https://www.23andme.com/topics/pharmacogenetics/cyp2c19/" target="_blank" rel="noreferrer noopener">CYP2C19</a>, <a href="https://www.23andme.com/topics/pharmacogenetics/dpyd/" target="_blank" rel="noreferrer noopener">DPYD</a>, and <a href="https://www.23andme.com/topics/pharmacogenetics/slco1b1/" target="_blank" rel="noreferrer noopener">SLCO1B1</a> — affect the body’s ability to metabolize or transport those medications.



Under the <a href="https://blog.23andme.com/articles/fda-clearance">FDA authorization,</a> there is no additional confirmatory testing requirement for the SLCO1B1 Drug Transport report. A healthcare provider can use the results from the report to guide care. Remember that other factors besides your genetics can also affect how your body processes medications. In addition, customers should not change their medications without first consulting their healthcare provider.&nbsp;



<h6 class="wp-block-heading">Find Out More</h6>



23andMe+ members can view their <a href="https://you.23andme.com/health/pgt/" target="_blank" rel="noreferrer noopener">pharmacogenetics reports here</a>.



23andMe Health + Ancestry Service customers on the current genotyping chip can receive this report and 35+ other reports by joining 23andMe+ from within their accounts <a href="https://you.23andme.com/chip-upgrade/" target="_blank" rel="noreferrer noopener">link here to upgrade.</a> 



&nbsp;Not a 23andMe+ customer yet?<a href="https://www.23andme.com/compare-dna-tests/"> Learn more about what 23andMe offers here</a>.



<hr class="wp-block-separator has-alpha-channel-opacity"/>



<h6 class="wp-block-heading">Note:</h6>



*23andMe PGS Pharmacogenetics reports: The 23andMe test uses qualitative genotyping to detect 3 variants in the CYP2C19 gene, 2 variants in the DPYD gene and 1 variant in the SLCO1B1 gene in the genomic DNA of adults from saliva for the purpose of reporting and interpreting information about the processing of certain therapeutics to inform discussions with a healthcare professional. It does not describe if a person will or will not respond to a particular therapeutic. Our CYP2C19 Pharmacogenetics report provides certain information about variants associated with metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of citalopram and clopidogrel therapy.



Our SLCO1B1 Pharmacogenetics report provides certain information about variants associated with the processing of some therapeutics and provides interpretive drug information regarding the potential effect of simvastatin therapy. Our DPYD Pharmacogenetics report does not describe the association between detected variants and any specific therapeutic. Results for&nbsp; DPYD and certain CYP2C19 results should be confirmed by an independent genetic test prescribed by your own healthcare provider before taking any medical action.&nbsp; Warning: Test information should not be used to start, stop, or change any course of treatment and does not test for all possible variants that may affect metabolism or protein function. The PGS test is not a substitute for visits to a healthcare professional. Making changes to your current regimen can lead to harmful side effects or reduced intended benefits of your medication, therefore consult with your healthcare professional before taking any medical action. For important information and limitations regarding Pharmacogenetic reports, visit <a href="http://www.23andme.com/test-info">www.23andme.com/test-info</a>.

New Report Release image for Simvastatin Medication Insight

New 23andMe+ Report on Simvastatin

The U.S. Food and Drug Administration (FDA) has <a href="https://www.globenewswire.com/news-release/2022/10/27/2542610/0/en/23andMe-Granted-New-FDA-Clearance-to-Provide-Interpretive-Drug-Information-for-a-Commonly-Prescribed-Cholesterol-Medication.html" target="_blank" rel="noreferrer noopener">granted 23andMe </a>510(k) clearance for its pharmacogenetics report for the <a href="https://www.23andme.com/topics/pharmacogenetics/slco1b1/">SLCO1B1 genetic variant</a> to provide interpretive drug information for simvastatin.&nbsp;



<h2 class="wp-block-heading" id="h-among-the-most-commonly-prescribed-medication">Among the Most Commonly Prescribed Medication</h2>



Simvastatin is a medication in the statin family of drugs commonly prescribed to lower cholesterol to help reduce the risk of heart attack and stroke. In 2020, simvastatin was the second-most widely prescribed statin and the thirteenth-most<a href="https://clincalc.com/DrugStats/"> commonly prescribed</a> medication in the U.S.



A particular gene variation, SLCO1B1, influences the body’s response to simvastatin. 



<h2 class="wp-block-heading" id="h-ethnicity-matters">Ethnicity Matters</h2>



In<a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4889090/"> certain ethnicities</a>, up to 38 percent of people have a SLCO1B1 genotype that increases the possibility of experiencing side effects related to taking simvastatin, particularly statin-associated musculoskeletal symptoms risk.



In addition to providing interpretive drug information, the new FDA clearance also removes the requirement for confirmatory testing.&nbsp;



“This is an important win for consumers, as they will have access to critical information on how they may respond to a commonly prescribed medication based on their genetics,” said Noura Abul-Husn, M.D. Ph.D., Vice President of Genomic Health at 23andMe.



“A complete health picture requires a number of inputs, including genetics, which is too often overlooked in healthcare. With this clearance, we are continuing to champion access to actionable health information so that everyone can benefit from a personalized healthcare experience and avoid negative side effects of medications where possible.”

Another FDA Clearance to Provide Drug Information

A new genetic study may help those looking for ways to avert some of the troubling side effects of a common medication used to treat Parkinson’s disease.
Parkinson’s is sometimes treated with medication that increases dopamine activity in the brain. In some patients, that triggers impulsivity, such as compulsive gambling, shopping, eating, or hyper-sexuality.
<img loading="lazy" decoding="async" class="alignright size-medium wp-image-7843" src="https://blog-api.23andme.com/wp-content/uploads/2010/11/cartoon-pills-300x285.png" alt="" width="300" height="285" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2010/11/cartoon-pills-300x285.png 300w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2010/11/cartoon-pills.png 478w" sizes="auto, (max-width: 300px) 100vw, 300px" />
<h2>Impulse Control Disorder </h2>
In a study published in the journal<a href="https://onlinelibrary.wiley.com/doi/10.1002/acn3.51569"> Annals of Clinical and Translational Neurology,</a> researchers have identified genetic variants in Parkinson’s patients at risk for that problem. Using genetic modeling could help identify patients who are more likely to develop impulse control disorder due to prescribed dopaminergic medications. 
Using machine learning and statistical techniques, the team was able to create a risk model to identify those at the highest risk. 
In the paper, the researchers suggest that this might ultimately be used to make it easier for physicians treating those with Parkinson’s disease to identify those who should be prescribed an alternative to medication that increases dopamine activity, like levodopa.
<h2>Risk Models for Drug Interactions</h2>
The study used data from about 5,700 individuals with Parkinson’s disease. Most of the data came from 23andMe Parkinson’s research participants who consented to participate, with the remainder coming from two other research cohorts, one at the University of Pennsylvania and the other at the Parkinson’s Progression Markers Initiative. 
The research involved two major steps. The first looked at genetic variants associated with impulse control disorder in people with Parkinson’s. Once they identified these variants, researchers used machine learning and statistical techniques to create a risk model. This helped them identify individuals who were more likely to develop impulse control disorder if the prescribed medication affected the dopamine activity in their brains.
In evaluating the model, the researchers said it performed better than similar <a href="https://www.nature.com/articles/s41397-021-00260-6">pharmacogenetic models</a> already used in prescribing anti-platelet drugs.
While dopaminergic drugs are very important and effective in treating motor control issues in Parkinson’s patients, impulse control disorder side effects are relatively common. In this study, n 20-30 percent of those treated with dopaminergic drugs experienced impulse control disorder.  
Applying this pharmacogenetic approach could be effective at identifying those individuals better served by using an alternative to dopaminergic medications. One of those alternatives is the drug levodopa, the researchers said.

Study On Side Effects of Parkinson’s Medication

Most of us have at least one genetic variant that may alter how our bodies process certain commonly prescribed medications. Yet, very few of us know about it.
That’s because genetic testing for these variants, also known as <a href="https://www.23andme.com/test-info/pharmacogenetics/">pharmacogenetic</a> testing, is rare. But these genetic differences can impact how a person responds to certain prescribed medications.
<h6>CYP2C19 Drug Metabolism Medication Insights</h6>
This week 23andMe released two new Medication Insight reports* as part of our <a href="https://www.23andme.com/membership?ada=on">23andMe+</a> Membership. The membership offers more than ten new reports and features throughout the calendar year giving members even deeper insights into their health. 23andMe remains the first and only direct-to-consumer company with FDA-authorized pharmacogenetic reports.
Our two new reports provide medication insights on how a person’s <a href="https://www.23andme.com/topics/pharmacogenetics/cyp2c19/">CYP2C19 metabolizer profile</a> may impact citalopram and <a href="https://blog.23andme.com/articles/the-debate-over-clopidogrel-continues">clopidogrel therapy</a>. The reports look at clopidogrel, a blood thinner, and an antidepressant, citalopram. About 22 million people in the US are prescribed citalopram.<a id="f1" href="#a1">[1]</a> About 20 million have prescriptions for clopidogrel.<a id="f2" href="#a2">[2]</a> <a href="https://blog.23andme.com/articles/pharmacogenetics-report">23andMe’s FDA clearance</a> of these new reports also removes the need for confirmatory testing in a clinical setting for specific CYP2C19 outcomes. The reports explicitly state that customers should consult their healthcare provider before making any changes to their medications.
<img loading="lazy" decoding="async" class="alignright wp-image-28527 size-medium" src="http://35.88.189.111/wp-content/uploads/2020/09/PGt-Home-231x300.png" alt="23andMe mobile pharmacogenomics" width="231" height="300" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home-231x300.png 231w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home-790x1024.png 790w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home-768x996.png 768w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home-679x880.png 679w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home-910x1180.png 910w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/PGt-Home.png 1583w" sizes="auto, (max-width: 231px) 100vw, 231px" />
The <a href="https://ghr.nlm.nih.gov/gene/CYP2C19">CYP2C19 gene</a> provides the instructions for making the<a href="https://blog.23andme.com/articles/variants-and-drug-processing"> CYP2C19 enzyme</a>, which helps the liver process (or “metabolize”) important medications. The enzyme also helps to process other medications such as over-the-counter treatments for acid reflux and ulcers, called proton pump inhibitors.
Last year 23andMe in collaboration with UCSF published research confirming just how common some of these variants are. Our research indicates that for about 30 percent of our customers, clopidogrel will be “likely less effective.” For East Asian and South Asian customers, it’s more than half who’ll see that result. About 3 percent of customers have an “increased chance of side effects” result for citalopram. Among East Asians and South Asians the percentage is between 10 percent and 12 percent.
<h6>Actionable Results</h6>
These new reports are part of 23andMe’s larger offering of Pharmacogenetic Reports* on three genes that impact a total of 11 medications. Together they offer 23andMe+ members a new class of reports, giving them deeper insight into their health. The results are among the most highly actionable genetic reports consumers can receive.
It has long been known that genetics influences why people respond differently to certain medications. But it is very rare for people to learn about those differences before they’ve already been prescribed a medication.
The study by researchers from 23andMe in collaboration with UCSF found that the <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7719394/">majority of people</a> have at least one genetic variant in the CYP2C19 gene that impacts how the body processes certain medications, including clopidogrel and citalopram. Earlier this year, <a href="https://www.jacc.org/doi/10.1016/j.jcin.2021.01.024">a meta-analysis showed</a> that patients with loss-of-function variants in the CYP2C19 gene had a 30 percent reduction in ischemic events — including heart attacks and strokes — when treated with alternative antiplatelet medications, including ticagrelor or prasugrel, versus clopidogrel.
Our own research indicates that 70 percent of 23andMe customers would receive a potentially actionable result from our pharmacogenetic reports.<a id="f3" href="#a3">[3]</a>
<h6>Knowledge is Power</h6>
When it comes to medicines, we know that one size doesn’t necessarily fit all. Different people may respond differently to the same medicine due to factors like their age, weight, liver and kidney function, diet, or even other medicines they might be taking.
And we also know that for many medications, genetic factors also play an important role. Through our research and through the work of other scientists we’ve learned how common it is for people to have genetic variants that affect how we metabolize certain medicines. People could potentially benefit from knowing that they metabolize some medications differently than others.
23andMe’s Pharmacogenetic Reports offer consumers a chance to learn about these differences, and then to share that information with their healthcare provider so that they are better able to prescribe the right medicine at the right dose. Customers should not use their results to start, stop or change their medications without first consulting their healthcare provider.
If you are not yet a 23andMe+ member you can find out more <a href="https://www.23andme.com/membership">here</a>. 
<code></code>References:<code> 
</code><a id="f1" href="#a1">[1]</a> ClinCalc.com “Top 300 Drugs of 2021”; <a href=" https://clincalc.com/DrugStats/Top300Drugs.aspx "> https://clincalc.com/DrugStats/Top300Drugs.aspx </a><code> 
</code><code></code> <a id="f2" href="#a2">[2]</a> Ibid.
<footer class="footnotes"><code> </code><a id="f3" href="#a3">[3]</a> <a href="https://www.ahajournals.org/doi/10.1161/circ.140.suppl_1.16081">https://www.ahajournals.org/doi/10.1161/circ.140.suppl_1.16081</a><code> 
</code><a>&gt; </a></footer>
<footer class="footnotes"></footer>
<hr />
<h6>Note:</h6>
*23andMe PGS Pharmacogenetic reports: The 23andMe test uses qualitative genotyping to detect 3 variants in the CYP2C19 gene, 2 variants in the DPYD gene and 1 variant in the SLCO1B1 gene in the genomic DNA of adults from saliva for the purpose of reporting and interpreting information about the processing of certain therapeutics to inform discussions with a healthcare professional. It does not describe if a person will or will not respond to a particular therapeutic and does not describe the association between detected variants and any specific therapeutic. Our CYP2C19 Pharmacogenetic report provides certain information about variants associated with metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of citalopram and clopidogrel therapy. Results for SLCO1B1 and DPYD and certain CYP2C19 results should be confirmed by an independent genetic test prescribed by your own healthcare provider before taking any medical action.  
<h6>Warning: </h6>
Test information should not be used to start, stop, or change any course of treatment and does not test for all possible variants that may affect metabolism or protein function. The PGS test is not a substitute for visits to a healthcare professional. Making changes to your current regimen can lead to harmful side effects or reduced intended benefits of your medication, therefore consult with your healthcare professional before taking any medical action. For important information and limitations regarding Pharmacogentic reports, visit www.23andme.com/test-info.

Two New Medication Insight Reports for 23andMe+ Members

According to a new study from 23andMe and the University of California, San Francisco (UCSF) School of Pharmacy, most people have at least one genetic variant in the CYP2C19 gene that may alter how our bodies process certain commonly used medications. Most people don&#8217;t know about these variants because this kind of <a href="https://www.23andme.com/" target="_blank" rel="noopener">genetic testing</a>, called pharmacogenetic (&#8220;farm-uh-ko-genetic&#8221;) testing, isn&#8217;t yet widely used.
The 23andMe study, published in the online journal Clinical and Translational Science, confirms previous smaller studies and underscores the potential benefit that widespread preemptive pharmacogenetic testing could have.
&#8220;Our study reaffirms how common these variants are in how we metabolize certain medicines and how many people could benefit from knowing about them,&#8221; said Alison Chubb. &#8220;This is information they could share with their doctor if they ever need one of the relevant medications.&#8221;
<img loading="lazy" decoding="async" class="alignright wp-image-28452" src="http://35.88.189.111/wp-content/uploads/2020/09/CYP2C19-Variants-By-Ethnicity-300x169.png" alt="This graphic shows how common the CYP2C19 varaints are among 23andMe customers of different ethnicities." width="400" height="225" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/CYP2C19-Variants-By-Ethnicity-300x169.png 300w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/CYP2C19-Variants-By-Ethnicity-1024x576.png 1024w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/CYP2C19-Variants-By-Ethnicity-768x432.png 768w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/CYP2C19-Variants-By-Ethnicity-880x495.png 880w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/CYP2C19-Variants-By-Ethnicity-1180x664.png 1180w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2020/09/CYP2C19-Variants-By-Ethnicity.png 1280w" sizes="auto, (max-width: 400px) 100vw, 400px" /> 
Alison is a Senior Product Scientist at 23andMe and senior author of the study.
The study follows an FDA 510(k) clearance that modifies the agency’s previous clearance of 23andMe’s CYP2C19 Drug Metabolism report by removing the need for confirmatory testing and allowing the company to provide interpretive drug information based on genetic factors for two medicines: clopidogrel and citalopram.
<h2>CYP2C19 and Drug Metabolism</h2>
Regarding medicines, we know that one size doesn&#8217;t necessarily fit all. People may respond differently to the same medicine due to factors like age, weight, liver and kidney function, diet, or even other medicines they might be taking. However, genetic factors also play a role in some medicines, and the CYP2C19 (often pronounced &#8220;sip-two-see-19&#8221;) gene is one example.
The <a href="https://ghr.nlm.nih.gov/gene/CYP2C19">CYP2C19 gene</a> provides the instructions for making the CYP2C19 enzyme, primarily found in the liver, and helps the body process (or &#8220;metabolize&#8221;) important medications. For example, clopidogrel is a blood thinner for treating and preventing heart attacks, while citalopram is an antidepressant. The enzyme also helps process over-the-counter treatments for acid reflux and ulcers called proton pump inhibitors.
Specific inherited variants in the CYP2C19 gene impact how well the CYP2C19 enzyme works. People with these variants may process certain medicines faster or slower than usual, affecting how well the medicines work or the chances they&#8217;ll cause side effects. For a few medications, the potential impact of CYP2C19 variants is so strong that the FDA-authorized drug labels include a warning or dosing recommendation based on CYP2C19 genotype. To help summarize these actionable gene-drug effects, the FDA has recently published a helpful <a href="https://www.fda.gov/medical-devices/precision-medicine/table-pharmacogenetic-associations">table of pharmacogenetic associations</a> for healthcare providers that includes CYP2C19 and other genes.
<h2>23andMe Study Details</h2>
Researchers wanted to know just how common CYP2C19 variants are among 23andMe participants who have consented to research and how someone&#8217;s ancestry affects their chance of having one. The study looked at the distribution of the three most common CYP2C19 variants across nine self-reported ancestry groups. It found that almost 60% of the 2.29 million participants had at least one variant that could affect how they process certain medicines.
Two of the variants studied result in a CYP2C19 enzyme with decreased activity, and people with these variants may process some medicines slower than average. These variants were most common in participants with East Asian, South Asian, and Hawaiian or other Pacific Islander ancestry.
In contrast, the third variant that researchers looked at results in a CYP2C19 enzyme with more activity than normal, so some people with this variant may process certain medicines faster than normal. This variant was most common in people of European, African American, Ashkenazi Jewish, and Middle Eastern descent.
<h2>Real World Impact</h2>
Although people of Hispanic or Latino descent had the lowest rate of CYP2C19 variants compared to other groups, they still had a 50% chance of having at least one variant. The take-home message is that these pharmacogenetic variants are common across all ancestries, which is quite different from the distribution of many disease-related genetic variants that are often rare and ancestry-specific.
But what is the potential real-world impact of these findings?
To answer that, we need to know how many people actually use the medicines that depend on CYP2C19 metabolism. To get insight into this question, the researchers looked at prescription rates in the UCSF health system (2012-2019). They found that about 16% of patients had been prescribed one or more medications metabolized by CYP2C19. They then extrapolated from the 23andMe variant frequencies. They calculated that more than 120,000 prescriptions in the UCSF system were likely written for people with non-normal CYP2C19 metabolism. In addition, those patients might have benefited from knowing about their CYP2C19 variants before they started their medicines. This would have allowed them to discuss with their doctors the available options based on their genetic results.
<h2>Pharmacogenetics Reports at 23andMe</h2>
In October 2018, the <a href="https://blog.23andme.com/news/23andme-granted-the-first-and-only-fda-authorization-for-direct-to-consumer-pharmacogenetics-reports/">FDA granted 23andMe authorization</a> to report CYP2C19 variants and predicted metabolizer status directly to consumers. We were also able to include variants in seven other genes that also impact drug metabolism. The initial 23andMe Pharmacogenetics* reports, including the CYP2C19 Drug Metabolism report, will be available later this year.
_____________________________________________________________________
<h6>NOTE</h6>
*The 23andMe PGS test uses qualitative genotyping to detect 6 variants in 3 genes in the genomic DNA of adults from saliva to report and interpret information about the processing of certain therapeutics to inform discussions with a healthcare professional. It does not describe if a person will or will not respond to a particular therapeutic and does not describe the association between detected variants and any specific therapeutic. Results should be confirmed in a clinical setting with independent genetic testing before taking any medical action.  
Warning: Test information should not be used to start, stop, or change any course of treatment and does not test for all possible variants that may affect metabolism or protein function. The PGS test is not a substitute for visits to a healthcare professional. Making changes to your current regimen can lead to harmful side effects or reduced intended benefits of your medication, therefore consult with your healthcare professional before taking any medical action. For a complete list of the 6 variants tested.

Common Genetic Variants Impact Drug Processing

The U.S. Food and Drug Administration (FDA) granted 23andMe authorization to offer reports to customers on <a href="https://www.23andme.com/test-info/pharmacogenetics/">pharmacogenetics</a>, indicating how customers’ genetics may influence the way they metabolize certain medications.<img loading="lazy" decoding="async" class="alignright wp-image-26661 size-medium" title="pharmacogenetics" src="https://blog-api.23andme.com/wp-content/uploads/2018/10/New-PGT-logo-300x157.png" alt="" width="300" height="157" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2018/10/New-PGT-logo-300x157.png 300w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2018/10/New-PGT-logo-768x402.png 768w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2018/10/New-PGT-logo-1024x536.png 1024w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2018/10/New-PGT-logo-880x461.png 880w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2018/10/New-PGT-logo-1180x618.png 1180w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2018/10/New-PGT-logo.png 1200w" sizes="auto, (max-width: 300px) 100vw, 300px" />
The decision marks the first time the FDA has <a href="https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624753.htm">authorized</a> a direct-to-consumer genetic test for pharmacogenetics.

<h6> Pharmacogentics Test</h6>
“We&#8217;ve continued to <a href="https://blog.23andme.com/articles/a-note-to-our-customers-regarding-the-fda">innovate through the FDA</a> and pioneer safe, effective pathways for consumers to directly access genetic health information,” said 23andMe co-founder and CEO Anne Wojcicki. “Pharmacogenetic reports are an important category of information.  I believe this authorization opens the door for consumers to work with their health providers to better manage their medications.”
The authorization allows for the reporting of <a href="https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180028.pdf">variants in multiple genes</a> that impact how well an individual metabolizes certain medications.  For example how well they metabolize clopidogrel. Clopidogrel is commonly prescribed to prevent heart attacks and strokes. These genes are associated with response to more than 50 other commonly used medications.
<h6>Genetics Test for Medications</h6>
The authorization allows us to provide customers with information on whether they are fast or slow metabolizers. And we can report on whether they may experience reduced efficacy, or have an increased chance of side effects from certain medications.
It has long been established that genetics influence how people respond to different medications. Certain medications have for many years included labeling with pharmacogenetics information. The FDA started listing these in 2009. However, people often only learn that they process a medication differently after they begin taking it.
<h6>FDA and Pharmacogenetics</h6>
This latest <a href="https://blog.23andme.com/articles/pharmacogenetics-report">FDA authorization</a> follows several years of work by 23andMe. This work led to four separate FDA de novo authorizations for direct-to-consumer genetic tests. Those authorizations are for carrier status, genetic health risk reports, select BRCA1 and BRCA2 variants, and now <a href="https://www.23andme.com/membership" target="_blank" rel="noopener">pharmacogenetic reports</a>.
Each has included an extensive FDA review process. The process required 23andMe to submit studies demonstrating that our reports are scientifically valid and understandable for consumers. 23andMe also had to show that the results are analytically reliable.
<h6>Comprehension and Accuracy</h6>
In order to demonstrate this, 23andMe showed its tests have greater than 99 percent accuracy. Further, 23andMe had to demonstrate at least 90 percent user comprehension of the key concepts communicated in the reports.
User comprehension was an important part of the FDA’s evaluation of the pharmacogenetics reports. In this case it was not just looking to ensure that consumers understand the reports but also that they wouldn&#8217;t impact “treatment adherence.” That refers to whether or not a customer would stick to their prescribed treatment of a medication or whether a report would lead them to change or stop treatment. Our study showed that more than 97 percent of users understood that they should not use the report to make any changes to treatment without consulting their doctor.
Finally, the decision <a href="https://blog.23andme.com/articles/fda-clearance">continues the commitment</a> made by 23andMe to return all the types of genetic health information to customers that it offered before received an FDA warning letter in 2013.

23andMe Pharmacogenetics Report Authorization

From studies that explain how 23andMe’s massive database can accelerate the targeting and development of disease-fighting drugs, to DNA research which <img loading="lazy" decoding="async" class="alignright size-medium wp-image-6586" src="https://blog-api.23andme.com/wp-content/uploads/2010/05/23andMe_Logo_blog-300x300.jpg" alt="23andMe_Logo_blog" width="300" height="300" srcset="https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2010/05/23andMe_Logo_blog-300x300.jpg 300w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2010/05/23andMe_Logo_blog-150x150.jpg 150w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2010/05/23andMe_Logo_blog-271x271.jpg 271w, https://blog.pub.us-west-2.prd.23andme.us/wp-content/uploads/2010/05/23andMe_Logo_blog.jpg 350w" sizes="auto, (max-width: 300px) 100vw, 300px" />uncovers the legacy of dynamic mixing in the New World over the last 500 years, 23andMe will again put its best science forward at the annual meeting of the American Society of Human Genetics (ASHG). (If you&#8217;re at the conference come by our booth, #1905.)
<h6>San Diego Bound</h6>
This year’s gathering will be in San Diego, and it’s expected to attract more than 6,500 scientists over four days in October.
The annual event brings together the best and brightest minds in human genetics, and gives them a chance to share the latest research and findings. This year 23andMe will present more than a dozen abstracts on a wide variety of topics and participate in two platform discussions. You can search all abstracts being presented at the meeting by going here.
<h6>23andMe Presentations</h6>
Along with findings related to drug development and genetic ancestry, 23andMe researchers are also presenting abstracts on wide variety of topics.
Among those are a series of studies that look at different human traits, their possible relation to certain health conditions as well as the dynamics of shared traits between parents and their children.
One of 23andMe’s abstracts looks at the genetics associated with being a ‘morning person’ and how that might be related to depression and weight. Another abstract looks at why some individuals are more prone to cry than others and whether genes that are associated with crying are also likely to be involved in brain development. Our scientists have also found genetic associations for varicose veins, which point to genes that are involved in circulatory development. Beyond how those traits may be related to health conditions, our researchers have also explored traits parents share with their children, finding that while for almost no trait did we see parents and children more likely to be dissimilar than similar, we did find that, mothers’ traits were more strongly correlated to their daughters, than the father’s traits were associated with their daughters.
<h6>Research Data</h6>
23andMe’s scientists will also be presenting on how researchers are able to use 23andMe’s database to make genetic discoveries. In addition we have another abstract that looks at a way our scientists have improved a long-used method for detecting shared DNA segments that researchers use to study everything from whether two people are related, to human demography – the characteristics of a population that might include its size, composition and distribution – and even the heritability of disease.
The work being presented at ASHG is part of 23andMe’s larger research mission. In the last three years, 23andMe scientists have published papers in peer-reviewed scientific journals and dozens of other findings that continue to push our understanding of genetics.
Here is a list of 23andMe abstracts as well as abstract for which we collaborated with others:
<table style="background-color: #ffffcc; border-collapse: collapse; border: 1px solid #FFCC00; color: #000000; width: 100%;" cellspacing="3" cellpadding="3" border="1">
<tbody>
<tr>
<td>&#8211; Like Mother, Like Daughter: Analysis of Parent-Child Phenotypic Correlations for Hundreds of Medical and Behavioral Traits 
Author(s): E. Pierson, D. Hinds, A. Kleinman, N. Eriksson</td>
<td>&#8211; Genes Involved in Brain Development Influence Crying Habits -A Genome Wide Association Study 
Author(s): C. Tian, C. Y. McLean, E. Y. Durand, N. Eriksson, J. Y. Tung, D. A. Hinds</td>
</tr>
<tr>
<td>&#8211; Adopting Genomes &#8211; Motivations of Adopted Persons when seeking Personal Genomic Services 
Author(s): N. M. Baptista, D. A. Carere, J. R. Duggan, T. A. Moreno, J. L. Mountain, S. A. Broadley, J. S. Roberts, R. C. Green, and the PGen Study Group</td>
<td>&#8211; The genetic ancestry of African, Latino, and European Americans across the United States 
Author(s): K. Bryc, E. Durand, D. Reich, J. Mountain</td>
</tr>
<tr>
<td>&#8211; Shared genetic background between chronic gastroesophageal reflux and Barrett’s esophagus and esophageal adenocarcinoma, consistent with a causal relationship 
Author(s): P. Gharahkhani, J. Tung, T. L. Vaughan, D. C. Whiteman, S. MacGregor, Barrett’s and Esophageal Adenocarcinoma Consortium</td>
<td>&#8211; A Large Scale Genome Wide Association Study of Varicose Veins in the 23andMe Cohort 
Author(s): R. K. Bell, E. Y. Durand, C. Y. McLean, N. Eriksson, J. Y. Tung, D. A. Hinds</td>
</tr>
<tr>
<td>&#8211; Reducing pervasive false positive identical-by-descent segments detected by large-scale pedigree analysis 
Author(s): E. Y. Durand, N. Eriksson, C. Y. McLean</td>
<td>&#8211; GWAS of 89,283 individuals identifies genetic variants associated with being a morning person 
Author(s): Y. Hu, A. Shmygelska, D. Tran, N. Eriksson, J. Tung, D. Hinds</td>
</tr>
<tr>
<td>&#8211; Accelerating Drug Development with 23andMe Phenome-Wide Association Studies 
Author(s): F. Sathirapongsasuti, B. T. Naughton, J. L. Mountain, D. A. Hinds, J. Y. Tung, C. Y. McLean</td>
<td>&#8211; Genetic discovery in the 23andMe participant cohort 
Author(s): D. A. Hinds, C. A. M. Northover, M. H. McIntyre, C. Wilson, K. E. Huber, A. Kleinman, F. Sathirapongsasuti, R. K. Bell, E. Pierson, K. Bryc, A. S. Shmygelska, N. A. Furlotte, Y. Hu, C. Tian, E. Y. Durand, C. Y. McLean, B. Naughton, J. L. Mountain, N. Eriksson, J. Y. Tung</td>
</tr>
<tr>
<td>&#8211; Genome-wide Mega-Analysis on Myopia and Refractive Error in CREAM and 23andMe 
Author(s): V. J. M. Verhoeven, R. Wojciechowski, P. G. Hysi, Q. Fan, A. K. Kiefer, N. Eriksson, C. J. Hammond, N. A. Furlotte, C. C. W. Klaver, Consortium for Refractive Error and Myopia (CREAM)</td>
<td>&#8211; Risk prediction and Type II Diabetes 
Author(s): N. Furlotte, S. Dandekar, R. Smith, N. Eriksson, D. Hinds</td>
</tr>
<tr>
<td>&#8211; A trans-ethnic genome-wide association study of 21,483 cases and 97,977 controls identifies 27 genetic susceptibility variants for atopic dermatitis 
Author(s): L. Paternoster, M. Standl, H. Baurecht, J. Waage, M. Hotze, J. A. Curtin, K. BÃ¸nnelykke, D. Glass, D. A. Hinds, E. Melen, P. Sleiman, B. Feenstra, M. Pino-Yanes, H. T. den Dekker, M. Bustamante, I. Marenholz, B. Jacobsson, A. D. Irvine, A. C. Alves, M. M. Groen-Blokhuis, A. Franke, M. Ferreira, M. Tamari, N. Probst-Hensch, K. Williams, D. P. Strachan, S. J. Brown, J. Heinrich, D. M. Evans, S. Weidinger on behalf of the EAGLE Eczema Consortium</td>
<td></td>
</tr>
</tbody>
</table>

pharmacogenetics