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.
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.
Valsartan is used to treat high blood pressure and heart failure, and is also taken by patients who have suffered recent heart attacks.
The drug is available on its own or in combination with other active substances.
The Kenyan recall comes in the wake of a growing global trend that has seen governments recall valsartan-containing medicine that originated from Chinese firm Zhejiang Huahai.
The Chinese company in question has over the years supplied pharmaceuticals to Europe, America, Asia and Russia with bulk Valsartan.
A week ago South Africa recalled several batches of drugs containing the ingredient from Zhejiang Huahai following in the footsteps of the US where the Food and Drug Administration recalled large amounts of Valsartan-containing medicines.
Zhejiang Huahai, in an earlier statement, said its US unit was contacting distributors and customers for product return.
The Chinese firm has since stopped shipments and announced voluntary recalls in domestic and foreign markets.
European regulators said the problem may have started back in 2012 when Zhejiang Huahai changed the manufacturing processes, an indicator that many patients could potentially have been exposed to cancer risk.
In a July 17 statement EMA said investigations to ascertain the damage were now underway while stating that there was no immediate risk for persons taking Valsartan.
“While further assessment is needed, there is no immediate risk and patients taking Valsartan are advised not to stop their treatments unless they have been advised to do so by their pharmacist or doctor.
Healthcare professionals should follow specific advice from national authorities concerning medicines in their country,” said EMA in the statement.
EMA said it was also working with national authorities in the EU to evaluate whether other medicines containing Valsartan other than those being recalled could also contain the same impurity.
A Ministry of Health survey on non-communicable diseases shows that more than half or 56 per cent of Kenyans have never been tested for hypertension and it is estimated that about 4,000 people die locally yearly due to blood pressure complications. Heart failure is also the leading reason for the hospitalisation of senior citizens above 65, and it impacts more than 60 million people worldwide.