The U.S. Food and Drug Administration said that a recent recall of drugs used to control high blood pressure and prevent heart failure was due to an impurity that could possibly cause cancer.
According to the FDA, the products they recalled may contain N-nitrosodimethylamine (NDMA), a possible human carcinogen. Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd. were all asked by the FDA to recall their valsartan products. The companies Solco and Teva were also asked by the agency to recall their drugs that contained valsartan/hydrochlorothiazide (HCTZ).
In a statement, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said “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.”
The FDA is currently investigating the possible impacts the drugs have had on patients who have already consumed them. The agency is also looking into how to get rid of the impurity from future batches of these products. The FDA has advised patients taking the recalled products to continue doing so until they find a suitable replacement.
The companies that have been affected by the FDA’s recall have shared instructions for patients who use these drugs. The FDA also suggests that patients should consult with their pharmacist and the physician who prescribed the medicine to discuss what steps they should take next.
The European Medicines Agency announced early this year that it was investigating drugs with an active valsartan ingredient supplied by Zhejiang Huahai Pharmaceuticals for the same reason the FDA was investigating products in the United States. According to The New York Times, Zhejiang Huahai Pharmaceuticals supplied Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals Industries Ltd. with these products.
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