FDA Expands Recall of Blood Pressure Drugs Due To Cancer Concerns

The United States Food and Drug Administration has expanded the recall scope 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.

NDMA is classified as a probable human carcinogen — a substance that could cause cancer. Those findings are based on results from recent laboratory tests.

Last month, the FDA issued a voluntary recall on some valsartan tablets and has since expanded that recall twice to include additional products from more drug companies.

It’s concerning, of course. But it’s important to realize the concern is with an impurity caused by a manufacturing process, not the drug itself.

“It’s not the drug that causes cancer,” said Moffitt cardiologist Michael Fradley. “The drug itself is quite good and important.”

To determine whether a specific product has been recalled, patients should look at the drug name and company name on the label of their prescription bottle. If the information is not on the bottle, patients should contact the pharmacy that dispensed the medicine.

The valsartan tablets (dosages 40 mg to 320 mg) the FDA has 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 80 mg/12.5 mg to 320 mg/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)

“If you get your valsartan from a manufacturer other than those listed, then you are fine to continue taking it,” Fradley said. “If your medication is from one of those companies listed, then you should contact your doctor for other treatment options.”