Valsartan Recall

Is Valsartan safe?

On July 13, 2018, the U.S Food and Drug Administration alerted health care professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan.

 

Valsartan is a commonly used prescription medication for treatment of high blood pressure and heart failure. Due to the serious medical conditions that this drug is indicated for, the FDA recommends that patients taking the recalled valsartan-containing medicines, should continue taking their medicine until they have a replacement.

 

Not all valsartan containing products are affected by this recall. Patients with their medicine included in the recall list should contact their health care provider or pharmacist to discuss alternative treatment options or another valsartan product not affected by the recall.

 

What is the Culprit?

The recall is due to an impurity called N-nitrosodimethylamine (NDMA), which was found in the recalled products. The FDA believes the sudden presence of NDMA is due to the way the substance was manufactured. NDMA is classified as a substance that could cause cancer, or a carcinogen. The amount of NMDA in the recalled products is currently under investigation as well as the possible effects that it can impose for patients that have been taking them, according to the FDA’s review. To date, there have been no reports of adverse events documented that is related to the recall.

 

To determine whether a specific product has been recalled, refer to the drug name and company name found on the label of the prescription bottle. Patients should contact the pharmacy that dispensed the medication if the information is not found on the bottle.

 

TEVA/MAJOR/SOLCO Product Image:

 

For More Info on NDMA:

For further information on what NDMA is and its effects, the World Health Organization provides a great in-depth summary found here:

http://www.who.int/ipcs/publications/cicad/en/cicad38.pdf

 

 

Resources:

  1. https://www.fda.gov/safety/recalls/ucm613625.htm

  2. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm

  3. https://www.pharmacytimes.com/news/voluntary-recall-of-several-medicines-containing-valsartan-following-impurity-detection-

  4. https://www.majorpharmaceuticals.com/wp-content/uploads/2018/07/Valsartan_Recall_Major_Pharm_Press_Release_Final_07132018.pdf

     

     

     

     

     

     

     

     

     

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