Product News and Recalls

New Impurity Discovered in Heart Medication

Several medications containing valsartan, a component of generic medications used to treat high blood pressure and heart failure, were found to be tainted with a chemical impurity earlier this summer. The discovery of NDMA in the drug, a chemical used in everything from rocket fuel to fish processing, led to a voluntary recall of several valsartan-based medications in July.

NDMA, or N-nitrosodimethylamine, is listed as a possible human carcinogen with the EPA. And while not all valsartan-based medications were found to be tainted, enough of the chemical was found throughout several lots of medications to warrant the initiation of a voluntary recall.

A second valsartan impurity was discovered earlier this month. Testing of subsequent lots of drugs manufactured by Torrent Pharmaceuticals found that a separate compound called NDEA was also present in valsartan that had been manufactured by Zhejiang Huahai Pharmaceuticals and used in Torrent’s medications. The discovery has led to action from both the FDA and Health Canada although no reports of any adverse effects have been received as of yet.

Patients who are taking valsartan-based medications have been advised to continue taking those medications but to speak with their doctors or pharmacists to determine whether their medications are a part of this latest recall. In some cases, a pharmacist may also be able to swap out a given dose for a dose from a lot not affected by the recall. In others, a doctor may opt to simply change the patient’s prescription.