Authorities in the health sector in Nigeria have joined their counterparts around the world in taking proactive steps to forestall a possible outbreak of cancer occasioned by contaminated Valsartan brand of anti-hypertensive drug.
Already, the National Agency for Food and Drug and Administration and Control (NAFDAC), has ordered all importers, wholesalers and retailers of drug products to immediately stop importation, distribution and sale of all batches of Valsartan capsules and tablets in Nigeria.
NAFDAC also advised anybody in possession of these products to submit them to the nearest NAFDAC office just as it urged healthcare providers to stop the administration of these products to patients and submit any quantity in their possession to the nearest NAFDAC office. Consumers are also advised to report adverse events related to the use of any of these products to NAFDAC.
The order came on the heels of recent recall efforts of the anti-hypertensive drug by authorities in health in Europe for possible cancer link. The specific blood and heart drug products affected by the recall efforts according to reports are Valsartan sold by Major Pharmaceuticals, Teva Pharmaceuticals Industries, and Solco Healthcare based in the United States.
The news of the recall went viral when the Chinese manufacturers of the active ingredient for the drug, Zhejiang Huahai Pharma voluntarily informed the European Medicines Agency (EMA) that it had found in its Valsartan exported to Canada and Europe the chemical that is likely to cause cancer.
Authoritative sources such as the United States Environmental Protection Agency also say apart from cancer, exposure to high levels of NDMA can cause liver damage. At the same time, the European Medicines Agency is also reviewing the drug while recalls of these products are also on-going across Europe.
In a statement by EMA, “The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured.” On its part, Huahai has admitted in a statement shared to the Shanghai Stock Exchange, claiming that the new manufacturing system had until that time gotten approvals from related countries, stating that the amount of NDMA detected in the drug is “extremely small.”
An aggrieved citizen in Canada, Yvonne Harding responding to the news of the recall, thus complained concerning the damage caused by this medication: “My mom has been taking Valsartan for years and is now in the hospital because she had bladder cancer. She’s had three surgeries and they finally had to remove her bladder. These three surgeries were done in a 1 month period and she is now so weak that we have to teach her how to walk again. So why did it take so long for this medication to be recalled, and why are we buying this crap from China?”
Following all of this, experts have seriously advised that people who are taking the affected medication should contact their health care practitioners as soon as possible to discuss their treatment option.
Below are the specific Valsartan drugs that NAFDAC published on its website urging the public to desist using them in the management and treatment of blood and heart related disease.
Product Name Marketing Authorisation Holder Product License
|Valsartan 40mg capsules, hard||Dexcel Pharm Limited||PL 14017/0192|
|Valsartan 80mg capsules, hard||Dexcel Pharm Limited||PL 14017/0193|
|Valsartan 160mg capsules, hard||Dexcel Pharm Limited||PL 14017/0194|
|Valsartan 40mg film-coated tablets||Actavis Group PTC EHF||PL 30306/0109|
|Valsartan 80mg film-coated tablets||Actavis Group PTC EHF||PL 30306/0110|