FDA joins recall of 22 common cardiac drugs

Valsartan is off patent and is used as a component of other generic drugs, but not all drugs containing the ingredient are involved, according to the FDA. The US recall includes versions of valsartan manufactured by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. and valsartan / hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

In Europe and Asia, Novartis, the company at the origin of the drug, stated that Sandoz valsartan and valsartan / HCT film-coated tablets are recalled because they do not meet our high quality standards.It is advisable for pharmacies in the UK to recall batches of valsartan containing drugs manufactured by Dexcel Pharma Ltd and Accord Healthcare.

The recall is due to the presence of the impurity, N-nitrosodimethylamine (NDMA), contained in the recalled products, according to a statement by the FDA.

NDMA is an organic chemical that belongs to a family of potent carcinogens. It has been used to make liquid rocket fuel, softeners and lubricants, among other products. It can also be unintentionally produced by certain chemical reactions and is a by-product of the manufacture of certain pesticides, the manufacture of rubber tires or the processing of fish.

Eric Althoff, spokesman for Novartis, said this recall, but the FDA's ongoing review and laboratory tests have concluded the opposite. "The presence of NDMA was unexpected and would be linked to changes in the way the active substance was manufactured," the FDA said.

"The amounts of NDMA found in the Valsartan API are much lower than the cumulative endogenous production and the usual external exposure of the NDMA," Althoff writes in an email on July 6. "There is no certainty as to how, the amount of NDMA found in the Valsartan API would not pose a significantly increased risk for patients taking Sandoz Valsartan and Sandoz Valsartan HCT film coated tablets."

The FDA's investigation into the drug will continue "The FDA is committed to maintaining our standard of excellence in safety and effectiveness, including our efforts to to guarantee the quality of medicines and the safety of their manufacture, "said Commissioner Scott Gottlieb on Friday. "When we identify failures in the quality of drugs and manufacturing issues that can create risks for patients, we are committed to acting quickly to alert the public and facilitate removal of products from the marketplace. We are looking to eliminate some drugs today, our drug shortage team is also working to meet the therapeutic needs of patients in the United States by providing them with adequate medications.