FDA Recalls Heart Medication Over Cancer Concerns

July 16, 2018 - 1:18 pm

DETROIT (WWJ) - The FDA (U.S. Food and Drug Administration) is recalling a drug used to control blood pressure and help prevent heart failure over concerns the drug may increase the user's cancer risk. 

The U.S. government waited a week after 22 other countries recalled valsartan, which contains a chemical that poses a potential cancer risk, before issuing their alert. 

"The FDA is committed to maintaining our gold standard for safety and efficacy. That includes our efforts to ensure the quality of drugs and the safe manner in which they’re manufactured,” said FDA Commissioner Scott Gottlieb, M.D. in a newsroom release. 

"This recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.

The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company."

Valsartan and Valsartan/Hydrochlorothiazide (HCTZ) is produced by several companies including; Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals. 

To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

Patients should also contact their healthcare professional (the pharmacist who dispensed the medication or doctor who prescribed the medication) if their medicine is included in this recall to discuss their treatment, which may include another valsartan product not affected by this recall or an alternative treatment option.

Find more information about the recall [HERE].