Tuesday, October 30, 2018

Valsartan Recall & What You Should Know




On July 13, 2018, the U.S. Food and Drug Administration (FDA) announced the recall of a popular generic medication used to treat high blood pressure and heart failure. This announcement marked America as the twenty-third country to recall the drug after a potentially harmful impurity was discovered in the drug’s active pharmaceutical ingredient (API) valsartan. It was initially determined that this contaminated ingredient was supplied by the Chinese manufacturer Zhejiang Huahai Pharmaceuticals. Many drug companies that used valsartan from this particular supplier voluntarily recalled their medications.

Throughout the remainder of July and into August 2018, the FDA’s investigation of the contaminated ingredient continued and the recall was expanded accordingly. The China-based company, Zhejiang Tianyu Pharmaceutical, and the India-based company, Hetero Labs Limited, were identified as additional suppliers of the contaminated valsartan.

On September 13, 2018, the FDA announced the discovery of a second impurity within some of the medications already recalled. Both impurities found in this worldwide investigation are classified as probable human carcinogens. 

This was a massive consumer drug recall affecting thousands of Americans. According to the American Heart Association, over 100 million adults in the United States live with hypertension or high blood pressure. That is nearly half of the U.S. adult population, and many of these people take medications that contain valsartan. It is easy to understand why this recall caused a great deal of alarm and confusion among American consumers. To clear up some of the questions and concerns about the valsartan recall, here are the main takeaways that consumers should understand:

Drug Recalls


Medications can be recalled for a number of reasons. However, not all of these reasons threaten the health or safety of consumers. It’s important to understand this and remain calm in the face of a consumer drug recall. The main reasons for a drug recall include a contamination like the one that prompted the valsartan recall, a health hazard that would risk patients’ lives, mislabeled medications, packaging or labeling defects, or manufacturing problems that threaten the quality of the drug. Discerning the reason for your drug’s recall will help you respond appropriately.

Valsartan


Valsartan was originally sold under brand names such as Diovan, Entresto, and Exforge until its patent expired and generic drugs were developed. It is a medication used to treat high blood pressure, heart failure, and other cardiovascular health conditions. If you learn nothing else from this article, understand the valsartan is safe. The reason the medications were recalled was due to a contamination of valsartan supplied by certain manufacturers. This affected some, but not all of the medications that include valsartan. The brand-name drugs mentioned earlier, for instance, were not affected by the recall. While you might take a generic drug containing valsartan, your medication may be completely safe and excluded from the recall.

Impurities


This first impurity discovered is called N-nitrosodimethylamine (NDMA). It is classified as a likely human carcinogen based on the results of animal studies. As the U.S. Environmental Protection Agency reports, exposure to NDMA resulted in tumor growth throughout major vital organs in animal test subjects, and it’s believed to cause liver damage in humans. The second impurity found was N-nitrosodiethylamine (NDEA), another likely carcinogen. The long-term effects caused by exposure to these two impurities remain unknown.

Consumer Response


Following an FDA drug recall, it is important to determine whether your medications were affected. The FDA posts a list of the specific medications recalled. Using the company name, lot number, and National Drug Code (NDC) found on your medication labeling, you can determine if your medication is included on the FDA’s list. If you cannot find this information, call your local pharmacist, and they should be able to answer your questions.

If you determine that your medication was recalled, call your doctor immediately. Depending on the condition you are treating, stopping your medication without your doctor’s approval could do more harm than remaining on the recalled medication. Talk to your doctor about alternative drugs that could replace the recalled medication, and unless otherwise instructed by your doctor, do not stop taking your medication until you have obtained a replacement. In the case of the valsartan recall, many patients were either prescribed another drug containing unaffected valsartan or an alternative blood pressure medication.

It is also important to mention that once you have switched to a new medication, be sure to pay close attention to your body and any side effects you might experience from the new drug. If you experience any adverse side effects on a medication, be sure to report your experience to the FDA through their MedWatch portal. Should you need medical services to treat adverse side effects of a drug, you might also consider taking legal action to compensate for the medical expenses.

Click here for the Worldwide Valsartan Recall Fact Sheet

Sources: 


www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm

www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm620499.htm?utm_campaign=09132018_PR_FDA%20update%20on%20ongoing%20valsartan%20investigation%20and%20impurities&utm_medium=email&utm_source=Eloqua&elqTrackId=AFC65E191707E7C0A35119014755F97D&elq=b95870fbdc1d48d99a96140f25879c9a&elqaid=5073&elqat=1&elqCampaignId=4047

https://newsroom.heart.org/news/more-than-100-million-americans-have-high-blood-pressure-aha-says

www.consumersafety.org/legal/valsartan-lawsuit/

www.fda.gov/downloads/Drugs/DrugSafety/UCM615704.pdf

www.epa.gov/sites/production/files/2017-10/documents/ndma_fact_sheet_update_9-15-17_508.pdf

www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf

www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home

www.consumersafety.org/legal/


Author - 

Caitlin Hoff
Health & Safety Investigator
CDC Certified: Health Literacy for Public Health Professionals

Author Bio: Caitlin Hoff writes to shine awareness on important consumer topics that affect people every day. Through her writing, Caitlin hopes to guide families and consumers towards smarter decisions that will improve their overall health. Visit her author page for more information.

Blog posting provided by Society of Certified Senior Advisors