Sunday, 21 October, 2018

FDA Recalls Blood Pressure, Heart Failure Medications

Common heart drugs recalled due to contamination Getz Pharma: A reliable source for Valsartan medicines
Gustavo Carr | 17 July, 2018, 03:25

There has been an impurity found in valsartan called N-nitrosodimethylamine (NDMA).

The FDA has announced a voluntary recall of several drugs that contain the heart drug valsartan because a possible carcinogen was found in the recalled products. The statistics have only risen since then, which means the consumption of Valsartan medicines is high. The DRAP Recall alert stated that a total of nine pharmaceutical companies in Pakistan are on the DRAP recall list and this list does not include Getz Pharma and its products: Cova, Covam and Cova-H. Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company.

It was not immediately clear from FDA's announcement whether these companies are in a way connected to Zhejiang Huahai Pharmaceuticals.

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Patients taking these prescriptions to treat serious medical conditions should keep taking them until they have a replacement product. But not all of their valsartan drugs feature material from that company, which the FDA did not name. The announcement was made a week after 22 countries had conducted their separate recalls of the same valsartan products. "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. It can also be unintentionally produced through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing. Previous trials with animals showed NDMA can trigger the growth of tumors in the liver, kidney, and respiratory tract. The agency said its drug shortages team is also trying to ensure an adequate supply of unaffected alternatives. The FDA said it is now investigating the levels of NDMA in the recalled products, assessing the effect on patients and working with Huahai to solve the problem in future batches.

Doctors and their patients are warned to check their medications containing the ingredient valsartan as they might have been manufactured incorrectly.