China-made heart drug recalled over cancer fears

Health secretary Sicily Kariuki. FILE PHOTO | NMG 

By ANNIE NJANJA

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Summary

• The Valsartan-containing products are made by Denk Pharma, a German pharmaceutical company that has sub-contracted a Chinese firm to produce the drugs.
• The Chinese company in question has over the years supplied pharmaceuticals to Europe, America, Asia and Russia with bulk Valsartan.
• Kenyan move is part of ongoing global action that started in Europe

Kenyan authorities have recalled 15 batches of six locally available heart and blood pressure drugs over fears that they may be carrying a cancer-causing impurity.

The Pharmacy and Poisons Board (PPB) said in a statement dated July 12 that its decision to recall all drugs containing Valsartan follows detection of a potent carcinogen, N-nitrosodimethylamine (NDMA) that has been reported in Europe as bearing potential cancer risk.

The Valsartan-containing products are made by Denk Pharma, a German pharmaceutical company that has sub-contracted a Chinese firm to produce the drugs.

“Pharmacy and Poisons Board wishes to bring to your attention the voluntary recall of the following listed Valsartan-containing products by Denk Pharma as a precautionary measure following the detection of an impurity in the Active Pharmaceutical Ingredient in certain Valsartan Products in the European Union,” the board said in a notice signed by Ministry of Health’s Head of Pharmacovigilance, Christabel Khaemba.

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

Potential risk

The European Medicines Agency (EMA) first reported the potential risk from the Chinese-supplied Valsartan on July 5 and started recalling medicines.
EMA said that based on results from laboratory tests, it had found that NDMA may cause cancer with long-term use.

On Tuesday, the PPB said the list of drugs on recall in Kenya includes CoValsar-Denk 80, CoValsar-Denk 160, CoValsar-Denk 320, Vaslar-Denk 80, Vaslar-Denk 160, and Vaslar-Denk 320 of batch numbers 20436, 19791, 20355, 20539, 20289 and 20460, respectively.

The batch number is a figure printed on the drug label that allows medicine to be traced from their creations to sale. The volume of the suspect products available locally was not immediately clear as the PPB had not responded to our questions by the time the paper went to press.

The board said in an earlier response to queries on the matter that the “recall is ongoing and an e-shot with the information on the medicines on recall has been issued to heath care workers.”

The PPB said that while it believes in EMA’s findings, it was conducting further investigations on the affected brands available locally.