FDA Joins 22 Countries in Recall of Common Heart Drug
On Friday, the U.S. Food and Drug Administration (FDA) announced a recall for valsartan, a common drug that is used to control blood pressure and prevent heart failure. The announcement comes one week after 22 other countries recalled it because the drug contains a chemical that poses a potential cancer risk.
Details of the Valsartan Recall
According to the FDA, valsartan is off-patent and is used as a component of other generic medicines; however, regulators note that not all medicines containing the ingredient are involved. Specifically, the U.S. recall only includes versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. as well as valsartan/hydrochlorothiazide (HCTZ) combinatios sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.
The director of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, offered reassurance to consumers, saying “We have carefully assessed the valsartan-containing medications sold in the United States, and we’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients.”
In Europe and Asia, Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan/HCT film-coated tablets are being recalled because they “do not meet our high quality standards.”
Pharmacies in the UK are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare.
Details of the Valsartan Cancer Risk
The recall is due to the presence of the impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products. NDMA is an organic chemical that is in 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 through certain chemical reactions and is a byproduct from some pesticide manufacturing, the making of rubber tires or fish processing.
According to the United States department of Health and Human services, animal studies have shown that NDMA can be toxic and cause tumors in the liver, kidney and respiratory tract. It can also be potentially harmful to humans in certain quantities. Exposure to high levels can cause liver damage and is a probable human carcinogen.
Patients are advised to talk to their doctor if they are taking the medication. They should not discontinue taking medication without a doctor’s permission. Going off their medication without supervision could be dangerous, according to the American Heart Association.
The FDA’s investigation into the drug will continue.
Contact an Experienced Drug Recall Attorney
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If you or a loved one have been injured by or have developed serious side-effects from the use of recalled medications or pharmaceuticals, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.