Valsartan tablets recalled due to detection of impurity

FDA Recalls Blood Pressure Heart Medicine After Cancer Causing Agent Discovered

A Chinese pharmaceutical company has announced a recall of blood pressure medicines containing valsartan from the US market after an impurity was found.

"Not all valsartan-containing medicines distributed in the United States have valsartan active pharmaceutical ingredient (API) supplied by this specific company", the FDA explained.

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.

The FDA advises that patients contact pharmacists or physicians for advice on alternate therapy in lieu of the recalled treatment. The US recall includes the the versions of valsartan that are made by Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd.as well as valsartan/hydrochlorothiazide (HCTZ) sold by Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

Earlier this year, the European Medicines Agency announced it was reviewing medicine with an active valsartan ingredient supplied by Zhejiang Huahai Pharmaceuticals, a China-based company, for the same reason. This information will be posted to the FDA's website. Their health care provider should be able to offer other treatment options, among them, another valsartan product that is not part of the recall. "That is why we've asked these companies to take immediate action to protect patients".

The impurity is the "probable carcinogen" N-nitrosodimethylamine; in regards to how this was introduced into the active ingredient, both the EMA and FDA suggested it had been introduced during a change in the manufacturing process. Zhejiang Huahai Pharmaceuticals supplied the three US -based pharmaceutical companies with these products, according to The New York Times.

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This recall is being conducted with the full knowledge of the U.S. FDA.

"The FDA is committed to maintaining our gold standard for safety and efficacy", said FDA Commissioner Scott Gottlieb, M.D.

The Ministry of Health and Wellness will continue to follow warnings from the worldwide regulatory agencies with respect to any changes in pharmaceutical products to continue to ensure the availability of safe and quality products to the public.

The FDA's investigation into the drug will continue.

Health experts are frightened that this will create a huge problem and can undergo out of the control. "There are so many drugs that are coming in from India and China and companies are buying and selling each other and you don't know what's what".

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