TANZANIA RECALLS CHINESE BLOOD PRESSURE MEDICINE DUE TO CANCER RISK

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Tanzania Food and Drugs Authority (TFDA) is recalling from the market Chinese-manufactured medications that were being used to treat high blood pressure and heart failure after lab tests done in United States found that the drugs contain cancer-causing substances(carcinogens).

The TFDA spokesperson Ms Gaudensia Semwaza toldThe Citizenthat the drugs, Dynaval Co 80/12.5 mg, 160/12.5 mg and 160/25 mg, are already being recalled since Friday last week. This, she said, was a precautionary measure.
The Citizenhas confirmed that the drugs were still on the market until Wednesday 25 July as the regulatory authorities strive to address the problem.

TFDA guidelines require that the authorities take such action in 14 days after an alert has been issued over the safety of drugs. Ms Semwaza said the process to recall the drugs would go on for 14 days.

Similar measures have been taken across Europe after the European Medicines Agency (EMA) raised the potential cancer risk from drugs on July 5.

On July 12 this year, the United States-based Food and Drug Administration (FDA) alerted health care professionals and patients to voluntarily recall several drug products containing the active ingredient valsartan, used to treat high blood pressure and heart failure.

The recall is due to an impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled products, said the FDA in a statement.

“However, not all products containing valsartan are being recalled. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests,’’ cautioned FDA.

“The presence of NDMA was unexpected and is thought to be related to changes in the way the active substance was manufactured,’’ FDA added.

The FDA’s review is ongoing and has included investigating the levels of NDMA in the recalled products, assessing the possible effect on patients who have been taking them and what measures can be taken to reduce or eliminate the impurity from future batches produced by the company.

Reports from South African media show that the company which manufactured the drug—Zhejiang Huahai, has already acknowledged that there was an impurity in some of its valsartan, which it said had sales of $50 million in 2017 and added on Monday this week that countries were recalling the products as a precautionary measure.
By Godwin Peter.





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