StemCell Therapy

OTTAWA, Feb. 5, 2020 /CNW/ -

Summary

IssueApotexInc.. 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 stoptaking 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 Canadacommunicatedthat 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 beenworkingto 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 affectedPatients who are taking an affected metformin drug.

What consumers should do

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

Company

Product Name/ActivePharmaceutical Ingredient(API)

DIN

Strength

Lot

Expiry

Apotex Inc.

APO-Metformin ER(Metformin HydrochlorideExtended-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

galement disponible en franais

SOURCE Health Canada

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

This entry was posted on February 5, 2020 at 11:41 pm and is filed under Diabetes. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |