Published: Fri, July 20, 2018
Health Care | By Oscar Goodwin

Chinese firm recalls heart drug as US, EU raise concerns

Chinese firm recalls heart drug as US, EU raise concerns

The recall in the United States includes versions of valsartan made by Solco Healthcare, Major Pharmaceuticals and Teva Pharmaceuticals Industries. The EMA subsequently issued an alert for recall of the finished drugs containing Valsartan manufactured by the Zheijhiang Huahai Pharmaceuticals Linhai China and contaminated with NDMA.

The Pharmacy and Drug Control department at the ministry said it received memos from worldwide organizations on the possibility of a carcinogenic flaw called n-nitrosodimethylamine (NDMA) in the active substance (Valsartan) manufactured by the company. And the FDA said that because valsartan is used to treat serious medical condition, patients should keep on taking the recalled products until they have a replacement.

The EMA has said there is "no immediate risk and patients taking valsartan are advised not to stop their treatments" unless advised by doctors.

The company supplies the ingredient to manufacturers producing some of the valsartan medicines available in the European Union, and some initial reports were that USA manufacturers were not affected.

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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.

FDA has asked the patients not to take any medicine manufactured by this company and do not buy any product in which there is no name of the manufacturer.

A Chinese pharmaceutical company has recalled its products after discovering that some batches contained a carcinogen substance. If you can't find the information on the bottle, you should contact your pharmacy. The presence of NDMA is thought to be related to changes in the way the active substance was manufactured.

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

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The FDA has said it will "continue to investigate this issue and provide additional information when it becomes available".

The products subject to this recall were distributed nationwide to wholesale and retail facilities, including hospitals and pharmacies. The distribution firm is notifying distributors and other customers by recall letter and arranging for return of all recalled products. The list of recalled products has been posted on the websites of many regulatory agencies, including the U.S. FDA, Health Canada, the Irish Regulatory Authority and the Jamaica Ministry of Health.

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

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