The authority says the drug, valsartan, has chemicals that may cause cancer and has also recalled it from markets.
The Food and Drug Administration has issued a voluntarily recall of high blood pressure and heart failure drugs following the discovery of an impurity, called N-nitrosodimethylamine (NDMA), in those products, according to a news release.
The recall doesn't include all products containing valsartan; valsartan medications made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd. are being recalled, along with valsartan/hydrochlorothiazide (HCTZ) from Solco Healthcare and Teva Pharmaceuticals Industries Ltd. The supplier has stopped distributing its product, known as the valsartan active pharmaceutical ingredient, and the FDA is working with the affected companies to lessen or remove it from future products. As of today, it operates in 22 countries across the globe.
The recalled medications have the have valsartan in them.
Patients taking these prescriptions to treat serious medical conditions should keep taking them until they have a replacement product.
"The amounts of NDMA found in Valsartan API are much lower than the cumulative endogenous production and usual external exposure of NDMA", Althoff wrote in an email July 6. "That includes our efforts to ensure the quality of drugs and the safe manner in which they're manufactured", FDA Commissioner Scott Gottlieb, MD, said in the statement. You should also follow the recall instructions provided by the specific company. "This is why we've asked these companies to take immediate action to protect patients", said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.
Animal studies have shown that NDMA can be toxic and cause tumors in the liver, kidney and respiratory tract. 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.
Anyone taking the information should also call their doctor or pharmacist to figure out what medication they should take.
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