Recall of cancer causing drugs will not affect supply, says Ministry

Afya House in Nairobi.This was on 15 September 2017. [Edward Kiplimo,Standard]
The Ministry of Health has given an assurance that there will be no shortage of drugs to treat blood pressure and heart disease in the country after a recall of 15 brands.

The drugs were said to contain cancer causing substances.

The recall was made in a notice by the Pharmacy and Poisons Board (PPB) dated July 12 which listed all the 15 batches of drugs that were to be pulled out of the market.

These are drugs that contain valsartan and originally manufactured by Denk Pharma, a German based pharmaceutical company.

Valsartan is usually prescribed to patients of high blood pressure or those who have had heart attacks and congestive heart failure.

High blood pressure is one of the risk factors to cardiac related conditions. Close to 100,000 persons die annually from complications related to blood pressure among them heart disease according to the Ministry of Health.

While Kenya is not the only country that has been forced to recall these batches, the board has insisted that there will be no shortage as a result.

“Other brands of the same medicine (valsartan) manufactured by other companies available in the market,” reads a statement from the board.

Already the Chinese pharmaceutical firm that was contracted to manufacture Valsartan, Zhejiang Huahai Pharmaceuticals (ZHP), based in Linhai, in eastern China, has initiated a worldwide recall of all the drugs, after it was found that they contained carcinogen substance as reported by the country’s government.

There has also been a recall in 22 countries across Europe and North America. The drugs were found to contain N-nitrosodimethylamine(NDMA), which according to World Health Organisation 2008 paper, there is conclusive evidence that it is a potent carcinogen.

“NDMA has been classified by International Agency for Research on Cancer as probably carcinogenic to humans. The mechanism by which NDMA produces cancer is well understood,” reads the paper titled Guidelines for Drinking-Water Quality, 2008.

According to the notice by the PPB which was signed by Christabel Khaemba on behalf of the Board’s Registrar Dr Fred Siyoi, the recall in Kenya was a precautionary measure following the detection of an impurity in the active pharmaceutical ingredient in certain Valsartan Products in the European Union.

“This is to allow investigations to ascertain which batches are affected and the amount of impurity per batch,” reads the notice.

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