Update – Drug Information Mylan-Valsartan recalled voluntarily as a precaution due to impurity

OTTAWA, November 28, 2018/ CNW / –

Problem:
Mylan ULC Pharmaceutical voluntarily recalls four batches of Mylan-Valsartan tablets (40 mg, 80 mg, 160 mg and 320 mg tablets) after testing revealed low levels of impurity, N-nitrosodiethylamine (NDEA).

Valsartan is a medicine used to treat patients with hypertension to help prevent heart attacks and strokes. It is also used in patients who have had heart failure or a recent heart attack.

The products are recalled as a precaution. While the concentrations of NDEA present in the active pharmaceutical ingredient (valsartan), manufactured by Mylan Laboratories Limited India, are low, they are higher than what is considered reasonably safe if the drug has been taken in the course of life. Given the length of time that the subject products are on the Canadian market, this recall is very cautious.

This last reminder is a follow-up to recent recalls and other measures taken in Canada and internationally because of the presence of NDEA and another impurity, N-nitrosodimethylamine (NDMA), in some drugs (see links below for associated communications). NDEA and NDMA are both classified as potential carcinogens for humans, which means that long-term exposure may increase the risk of cancer.

Health Canada continues to work with international companies and regulators to determine the extent and root cause of the problem and to confirm that the necessary steps are being taken to resolve it and prevent it from recurring. The ministry will monitor these recalls. If other safety issues are identified, Health Canada will take appropriate action and continue to inform Canadians.

This recall should not lead to a shortage because there are alternatives in the Canadian market. As in previous submissions regarding NDEA and NDMA, Health Canada advises patients taking these drugs without immediate risk because the risk of cancer is associated with long-term exposure to these impurities. Patients should not stop taking their medication without the advice of their health care provider.

What consumers should do

• Continue taking your medicine valsartan unless your health care provider advised you to stop.
• Contact your health care provider to discuss treatment options if you are using an affected product.
• Ask your pharmacist if you are unsure if you are taking a recalled product.
• Contact your health care provider if you have taken a recalled product and are worried about your health.
• If you have any questions about the recall, contact Mylan by phone at 1-800-575-1379 or by email at the following address: [email protected].
• Report any side effects or complaints related to a health product to Health Canada.

Products concerned

The following Mylan valsartan products are recalled.

(Note: A related list of other recalled or non-recalled valsartan products is available in this notice.)

Related Links

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SOURCE Health Canada