Health Canada recalls heart drug due to contamination with possible carcinogen


One-hundred-and-four drugs were cleared of the measure Monday while the remaining 115 carcinogen-containing pills remain off the market, following component analyses.

The decision was taken after active pharmaceutical ingredient (API) manufacturer Zhejiang Hauhai notified the European Medicines Agency (EMA) it had detected an impurity in its production of valsartan.

The recall was first issued on July 9th by the federal agency. The drug regulator for the European Union said it would conduct an assessment of the severity of the problem for those who are now taking drugs containing Valsartan. For example, Swiss company Novartis informed the ministry that their products containing valsartan are not impacted because these products do not contain the ingredient from external suppliers. "Patients should contact their pharmacist (s) to see if the drugs they're taking are indeed the affected, recalled valsartan products".

However, not all Valsartan contains the carcinogen, only that made in China, the drug ministry noted.

Health Canada has ordered a recall of a commonly used medication used to treat high blood pressure because of fears an impurity found in the drugs may cause cancer with long-term exposure. Of 484,682 kilograms of Valsartan imported over the last three years, only 13,770 kilograms, or 2.8 percent contain ingredients from China.

A Class 1 Medicines Recall is now underway with all valsartan containing medicines made by Actavis Group and Dexcel Pharma being recalled at a European level as a result of the potential contamination. He said the government needs to devise a system to alert patients if unforeseen problems arise concerning their medicine.

In addition, the Ministry of Health and Welfare is looking for ways to inform patients of their pharmaceutical history through the Drug Utilization Review software and said it has already granted full health insurance coverage for patients who were taking the contaminated drugs and need alternatives.