FDA recalls heart and blood pressure medicines due to cancer-causing substance

Grant Boone
July 20, 2018

The companies recalling their products include Major Pharameceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

Companies which are recognized pharmaceuticals are Major Pharmaceuticals, Teva Pharmaceuticals, Solco Healthcare.

The development comes following indications of the presence of an impurity, N-nitrosodimethylamine (NDMA), in the valsartan active pharmaceutical substance supplied by Chinese company Zhejiang Huahai Pharmaceuticals and used in these prescription medications. Patients who are on valsartan should continue taking their medication, as the risk of harm to a patient's health may be higher if the treatment is stopped immediately without any alternative treatment.

Valsartan/Hydrochlorothiazide (HCTZ) Teva Pharmaceuticals Industries Ltd.

Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient supplied by this specific company.

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The FDA points out that not all products containing valsartan are being recalled. "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, in the alert.

Patients and health care professionals are advised to report any adverse reactions from the recalled products to the FDA's MedWatch program. The agency also recommends that consumers determine if they are taking a recalled product, find the company-specific recall instructions, and contact their pharmacy and physician. Vulsartan is the commonly used medication used to treat high blood pressure and heart failure. Not all medicines containing the ingredient have been recalled. The FDA also said patients should talk to their pharmacists and doctors who prescribed the medicine to discuss their next steps.

"EMA has made this aspect of the review a priority and will update the public as soon as new information becomes available", the agency said.

This recall is being conducted with the full knowledge of the U.S. FDA. Also, the FDA said there is a link between valsartan and cancer. It noted that Valsartan products on the Barbados market are produced by Novartis and Jubilant and are not subject to the recall.

The FDA previously reported that imported medications and their ingredients may not have been evaluated for safety and effectiveness in the USA, even if they were legal in foreign countries.

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