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MoH recalls heart medication Valsartan

BELMOPAN, Wed. July 25, 2018– Yesterday, the Ministry of Health issued a press release saying that they have been alerted to a “precautionary product recall” from the European Medicines Agency (EMA) on drugs containing Valsartan, which is commonly used to treat high blood pressure and heart failure.

The release mentions that the recall was prompted by the discovery of N-nitrosodimethylamine (NDMA) in the recalled products. Lab tests have shown that NDMA poses a potential cancer risk.

This recall is taking place all over the world, with countries in Europe and Asia recalling the medications from earlier in the month. The US Food and Drug Administration had also announced a recall earlier in July, according to websites such as healthline and fiercepharma.

Healthline reported on a conversation they had with Dr. Victoria Shin, a cardiologist with Torrance Memorial Medical Center in Torrance, California, who told them that the drug, Valsartan, is not the problem. Shin told healthline that the problem is “a contaminant that was included in the manufacturing process,” so “patients shouldn’t lose faith in the drug itself.”

Shin also mentioned that she does not believe the recall should affect patient care, because other Valsartan products are available for use.

The affected drugs are generic versions of a brand named Diovan, which is made by Novartis International AG, a pharmaceutical company based in Basel, Switzerland. Novartis first developed the Valsartan drug, and since then its patent has expired, and the formula the company developed is now widely used by drug makers.

While not all generic versions of the drug are affected, the contaminated batch seems to have stemmed from a pharmaceutical company in China. Zhejiang Huahai Pharmaceutical, in Linhai, volunteered information to the EMA that they had found the NDMA in the Valsartan they provide to the European market.

Hence, not all products containing Valsartan are being recalled — just those that contain the active pharmaceutical ingredient (API) that contains the NDMA that was traced back to Zhejiang Huahai Pharmaceutical. Zhejiang Huahai has since stopped distributing its Valsartan API.

The Ministry of Health’s press release says that based on the Ministry’s importation data, they have “asked pharmaceutical importers/wholesalers to recall a specific batch series of the Denk Germany and Actavis UK brands of this medication.”

They have also “asked pharmacies to stop supplying the product and immediately return the stock to their supplier.”

The release ends by saying, “the EMA is evaluating the potential impact on patients of the exposure to NDMA in Valsartan medicines. It has been recommended by EMA that patients continue taking the Valsartan medicine until they contact their doctor or pharmacist as there is no immediate risk.”

The link to Healthline’s  Blood Pressure Meds Are Being Recalled — Here’s What to Know article is https://www.healthline.com/health-news/blood-pressure-meds-recalled-heres-what-to-know.

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