Information Update - Apotex Inc. recalls certain lots of the diabetes medication APO-Metformin ER (extended release) 500 mg tablets

OTTAWA, Feb. 5, 2020 /CNW/ -

Summary

• Product: Certain lots of APO-Metformin ER (extended release) 500 mg tablets manufactured by Apotex Inc.
• Issue: Apotex Inc. is recalling certain lots because they contain a nitrosamine impurity above the acceptable limit.
• What to do: You should not stop taking your medication without first discussing treatment options with your health care provider. The risks from not having adequate diabetes treatment outweigh any possible effects of exposure to the levels of nitrosamines found in the recalled Apotex metformin products.

Issue
Apotex Inc. is recalling eight lots of its 500 mg extended release metformin tablets ("APO-Metformin ER") because they contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA) above the acceptable limit. Apotex Inc. has tested all lots of its 500 mg extended release tablets; only the affected lots are being recalled (see table below). There are also alternative metformin products on the Canadian market manufactured by other companies.

Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes.

Individuals taking metformin, including a recalled product, should not stop taking it unless they have spoken to their health care provider as the risks from not having adequate diabetes treatment outweigh any possible effects of exposure to the levels of NDMA found in the recalled products.

NDMA is classified as a probable human carcinogen. We are all exposed to low levels of nitrosamines through a variety of foods (such as smoked and cured meats, dairy products and vegetables), drinking water and air pollution. NDMA is not expected to cause harm when ingested at low levels. A person taking a drug that contains NDMA at or below the acceptable level every day for 70 years is not expected to have an increased risk of cancer.

In December 2019, Health Canada communicated that it is assessing the issue of NDMA in metformin products, after some metformin products available outside Canada were detected to contain NDMA above the acceptable limit. The Department asked companies to test their metformin products and is conducting testing in its own laboratories. Health Canada is also working closely with international regulatory partners, including the U.S. Food and Drug Administration and the European Medicines Agency, to inform its assessment. Health Canada continues to assess this issue, and will update the table below and inform Canadians should any additional recalls be necessary.

Health Canada has been working to address the issue of NDMA and other nitrosamine impurities found in certain medications since the summer of 2018. Health Canada continues to work closely with international regulatory partners to address the issue. The Department will take action if a new risk to Canadians is identified, and will continue to inform the public of new safety information.

Who is affected
Patients who are taking an affected metformin drug.

What consumers should do

• You should not stop taking your metformin drug without first discussing options with your health care provider. The risks from not having adequate diabetes treatment outweigh any possible effects of exposure to the levels of NDMA found in the recalled products. Stopping metformin medication could lead to uncontrolled diabetes, which can cause some serious health problems:
• Symptoms of high blood sugars include increased urination, thirst, excessive hunger, fatigue, blurred vision, drowsiness, irritability, unintended weight loss and dizziness. Very high blood sugars can lead to effects such as vomiting, diarrhea, dehydration, confusion, agitation and coma.
• Longer-term health impacts include heart disease, nerve problems, kidney damage, blindness and amputations.
• Talk to your health care provider to discuss treatment options if you are taking a recalled product or if you have taken a recalled product and are concerned about your health.
• Ask your pharmacist if you are unsure whether you are taking a recalled product.
• Report any health product adverse events or complaints to Health Canada.
• Contact the company directly if you have questions about a recall:
• Apotex Inc. via Stericycle ULC by calling toll-free at 1-855-853-9461.

Affected products
The following is a list of metformin drugs being recalled in Canada at this time:

Company	Product Name/Active Pharmaceutical Ingredient (API)	DIN	Strength	Lot	Expiry
Apotex Inc.	APO-Metformin ER (Metformin Hydrochloride Extended-Release Tablets)	02305062	500 mg	NV3242	04/2020
				NV3244	04/2020
				NV3245	04/2020
				NV3243	04/2020
				NV3247	04/2020
				NV3248	04/2020
				PX5334	01/2021
				PX5335	01/2021

Related links

• Health Canada evaluating NDMA in metformin drugs (2019-12-05)
• Health Canada updates Canadians on its ongoing assessment of nitrosamine impurities in certain drugs (2019-12-02)
• Multiple recalls of ranitidine drugs; request to stop distribution remains in place while Health Canada continues to assess NDMA
• Impurities found in certain angiotensin II receptor blocker (ARB) products, also known as sartans

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SOURCE Health Canada

Media Inquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]