Monday, 24 September, 2018


Recall of Valsartan containing drugs

Health Canada A sign is displayed in front of Health Canada headquarters in Ottawa on Jan. 3 2014
Patty Aguilar | 13 July, 2018, 22:07

The offending impurity is N-nitrosodimethylamine (NDMA), which has been listed as a probable carcinogen by the International Agency for Research on Cancer.

The Ministry of Health and Prevention (MOHAP) issued a circular ordering the recall of some antihypertensive medicines containing the active ingredient Valsartan, manufactured by Chinese company Zhejiang Huahai Pharmaceutical after the detection of impurities in the active ingredient.

"Patients should not stop taking their medicine if it contains valsartan unless they've been specifically instructed to do so by their prescriber or pharmacist", Nakhla said. "The pharmacist can then figure out alternative medications that are unaffected by the recall".

If you are in a clinical trial with valsartan and have any questions, speak to the doctor treating you in the trial. Further information will be provided once available.

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. The recall order was sent to authorized agents and distributors of the recalled products with an order to quarantine all quantities of the products present within their warehouses.

Drugs containing valsartan are used to treat patients with high blood pressure to help prevent heart attacks and stroke. "This active substance is used in a number of medicines marketed in Europe".

The review will be carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which will adopt the Agency's opinion.

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