FDA expands recall of heart drug for possible cancer-causing contamination
A popular drug used to treat high blood pressure has been recalled because some products may contain a cancer-causing chemical.
In an ongoing investigation, the Food and Drug Administration has expanded the swath of the recall of the drug valsartan, which is used to treat high blood pressure and heart failure. The recalled drugs, manufactured by Zhejiang Huahai Pharmaceuticals in Linhai, China, contain the chemical N-nitrosodimethylamine, or NDMA, which has been found to cause cancer in humans based on laboratory studies, the agency says.
Last month, the FDA issued a voluntary recall for some valsartan tablets and has since expanded it twice to include additional products from more drug companies, as well as some tablets with valsartan and hydrochlorothisazide (HCTZ).
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The valsartan tablets (dosages 40mg to 320mg) recalled include products from the following drug companies:
•A-S Medication Solutions (labeled as Solco Healthcare)
•Bryant Ranch Prepack
•HJ Harkins Company
•Northwind Pharmaceuticals
•Prinston Pharmaceutical Inc. (labeled as Solco Healthcare)
•Teva Pharmaceuticals Industries Ltd. (some labeled as Actavis, some as Major Pharmaceuticals)
Recalled valsartan/hydrochlorothiazide tablets (dosages range from 80mg/12.5mg to 320mg/25 mg) include products from these drug companies:
•AvKARE
•A-S Medication Solutions
•Northwind Pharmaceuticals
•Prinston Pharmaceutical (labeled as Solco Healthcare)
•Proficient Rx
•Remedy Repack
•Teva Pharmaceuticals (some labeled as ACtavis)
Not all valsartan products contained NDMA, the agency says; the FDA has a list of drugs with NDMA and those not affected on its website.
Consumers taking any medication with valsartan can compare their prescription bottle to the FDA's list to determine if their drugs have been recalled. Patients can also contact their pharmacist, who may be able to provide valsartan from a drug maker not involved in the recall, the FDA says.
Patients taking these medications should continue taking them until their doctor or pharmacist has a replacement drug or treatment, the FDA says.
The Environmental Protection Agency considers NDMA a carcinogen that can cause liver damage in humans. The FDA's scientists estimate that one additional case of cancer would develop over the lifetime of 8,000 patients had they all taken the highest valsartan dose (320 mg) from the recalled batches daily for four years -- the length of time some levels of the chemical impurity may have been added.