ibusinesslines.com October 22, 2018

FDA Recalls Heart Medications Containing the Active Ingredient Valsartan

20 July 2018, 09:46 | Melissa Porter

FDA Recalls Heart Medications Containing the Active Ingredient Valsartan

David Watkins  Shutterstock

The popular drug is used to treat high blood pressure, which affects one quarter of Barbadians over the age of 40.

Three companies agreed to voluntarily pull the generic drug containing valsartan after the U.S. Food and Drug Administration reported that it may be tainted with the human carcinogen N-nitrosodimethylamine (NDMA). The companies recalling their products include Major Pharameceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd.

As a result, the Drug Regulatory Authority of Pakistan (Drap) triggered a recall of all valsartan containing medicines having made using same source of active substance. "This is why we've asked these companies to take immediate action to protect patients".

Patients and doctors are being warned to ensure that the valsartan that they are taking is not being manufactured by this particular company.

"The recall is huge, based on the volume and the large number of patients it could have impacted", said Brito, "but we believe this could get offset by other players stocking up in short term".

The FDA advises that patients contact pharmacists or physicians for advice on alternate therapy in lieu of the recalled treatment.

Interesting thing is that every single of the carcinogenic medicines are made in China and also by the same company named as Zhejiang Huahai Pharmaceuticals Co. Ltd.

The supplier has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.

Valsartan is described as an angiotensin-II-receptor antagonist used to treat hypertension, recent heart attack and heart failure.

The FDA is continuing to investigate the issue and will add more information as it becomes available.

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.

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

FDA responses have reignited the matter of health and safety. "It just makes me wonder if there's a link", Meade said. "It's becoming very hard for me to write prescriptions at all".

Overall, more than two-thirds of all active drug ingredients originate in China and India, industry experts estimate, with China accounting for the lion's share.

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