The U.S. Food and Drug Administration has issued a voluntary precautionary recall on common drugs including active ingredient valsartan, which is found in prescribed drugs used to treat high blood pressure and help prevent heart failure.
The FDA is now looking into the potential impacts the drugs have had on patients who have already taken them, as well as how to get rid of the impurity from future batches of these products.
Certain lots of the therapy, distributed under the Actavis label in the U.S., have been detected to have trace amounts of probably human carcinogen N- nitrosodimethylamine (NDMA). "The presence of of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured", the FDA release said. The review will also see if other valsartan medicines are affected.
The FDA advises that patients contact pharmacists or physicians for advice on alternate therapy in lieu of the recalled treatment. He said the importers of the Zhejiang Huahai-supplied valsartan included Karachi's Amarant Pharmaceuticals, Efroze Chemical Industries, High-Q Pharmaceuticals, Pharm-Evo, Safe Pharmaceuticals, Sami Pharmaceuticals and Tabros Pharma, and Lahore's Searle Pharmaceuticals and Genetics Pharmaceuticals. When contacted, DRAP deputy director (quality control) Abdul Sattar Sohrani confirmed the recall orders and said the pharmaceutical firms concerned had been given one week to remove from the market the medicines made from Zhejiang Huahai's valsartan.More news: India impatient with KL Rahul, Rahane; MS Dhoni struggling: Ganguly blasts selection
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The FDA points out that not all products containing valsartan are being recalled.
If the patient is following the last prescription then he or she should remember the previous instructions given by the doctors and the company, which will be easily available on the website of FDA. Their health care provider should be able to offer other treatment options, among them, another valsartan product that is not part of the recall. In some patients, vulsartan is becoming life-saving medicine. Zhejiang Huahai Pharmaceuticals supplied the three USA -based pharmaceutical companies with these products, according to The New York Times. FDA has come up with the new solution of avoiding the vulsartan till when the doctor doesnot provide the substitute of this medication.
The Ministry of Health and Wellness will continue to follow warnings from the worldwide regulatory agencies with respect to any changes in pharmaceutical products to continue to ensure the availability of safe and quality products to the public.
The FDA will continue its investigation into the drug. "It just makes me wonder if there's a link", Meade said.