Nigeria bans Valsartan blood pressure drug


The Nigerian government has warned drug marketers to immediately stop the importation, distribution and sale of Valsartan, a drug used to control blood pressure and to prevent heart failure.

The National Agency for Food and Drug Administration and Control (NAFDAC) gave the warning in a statement on its websiteTuesday.

According to the statement, the ban on the drugs became necessary after the agency was notified by Medicines and Healthcare Products Regulatory Agency (MHRA) that all batches of Valsartan capsules manufactured by Dexcel Pharma Ltd and all batches of Valsartan tablets manufactured by Accord Healthcare previously known as Actavis Group PTC EHF are being recalled from pharmacies as a precautionary measure at a European level.

The recall, the statement said, was due to possible contamination with N-nitrosodimethylamine (NDEA) which has genotoxic and carcinogenic potentials.

The contamination is as a result of change in the manufacturing process of the active substance (valsartan) manufactured in China.

“…Anybody in possession of these products are to submit them to the nearest NAFDAC office,” the agency said.

“Healthcare providers should stop the administration of these products to patients and submit any quantity in their possession to the nearest NAFDAC office.”

There has being an ongoing recall of blood pressure drugs in Europe, America and other western countries due to possibilities they are contaminated with organic chemical N-nitrosodiethylamine (NDEA), which is used to make liquid rocket fuel and is classified as a probable human carcinogen.

The United States Food and Drug Administration (FDA) last month updated its blood pressure drug recall list to warn consumers of the voluntary valsartan blood pressure medication callback.

A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met.

The ongoing blood pressure recalls began back in July when three drug companies, including Teva Pharmaceuticals, began recalling medications containing valsartan.

Other blood pressure drugs have been recalled over similar concerns.

In early November, another blood pressure drug, irbesartan, was recalled, followed in mid-November by a voluntary recall of losartan potassium hydrochlorothiazide tablets, also prescribed to treat hypertension.

As with the other valsartan blood pressure medications recalled, individuals are advised to contact their healthcare providers while continuing to take the recalled drugs. Suddenly stopping blood pressure medication of this type could cause other serious medical issues.

Abubakar Jimoh, NAFDAC director on media, could not be reached for clarification. He did not return calls or respond to text messages as at press time.

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