Following the recall of type 2 diabetes medication Metformin Hydrochloride Extended-Release (ER) by Apotex last week, the U.S. Food and Drug Administration or FDA has recommended more pharmaceutical companies, who are manufacturers of the drug formulation, to recall their products.
The agency had announced in a May 29 conference call the names of the five companies that have been contacted for implementing the recall. Apart from Apotex, the other four in the list include Amneal Pharmaceuticals, LLC, Actavis Pharma Inc., Lupin Pharma and Marksans Pharma Ltd.
On Monday, Amneal recalled all lots of Metformin Hydrochloride ER tablets, USP, 500 mg and 750 mg, within expiry, distributed in the U.S. out of caution after the FDA notified that seven lots of the drug it tested had issues.
However, Amneal confirmed that its Metformin Hydrochloride Immediate Release (IR) tablets, USP are not affected by the recall. FDA testing has not shown NDMA in IR metformin products of any manufacturer.
Both Apotex and Amneal have not received any reports of adverse events that have been confirmed to be directly related to the recalls.
The recalls were announced after the FDA found the potential presence of nitrosamine impurity, N-Nitrosodimethylamine (NDMA), above levels of the Acceptable Daily Intake Limit (ADI) prescribed by the agency in several lots of the drugs ER formulation.
NDMA, a known environmental contaminant, is classified as a probable human carcinogen that could cause cancer. This is generally found in water and foods, including meats, dairy products, and vegetables.
Metformin Hydrochloride ER is an oral antihyperglycemic drug used in the management of type 2 diabetes. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus, particularly in over weight patients.
The FDA began testing metformin in the U.S. supply after it become aware of NDMA in some metformin products in other countries in late 2019.
The FDA noted that there are other manufacturers of the metformin ER formulation that supply a significant portion of the U.S. market, and their products are not being recalled.
Patients have been advised by the FDA to continue taking metformin tablets even after recalls until they consult with their health care professional who can prescribe a replacement. Patients with type 2 diabetes could face dangerous health risks if they stop taking their prescribed metformin.
At this time, the agency found that the elevated levels of NDMA have been found in some finished-dose tablets of the ER formulation but have not detected NDMA in samples of the metformin active pharmaceutical ingredient (API).
In April, the FDA had requested manufacturers to recall all prescription and over-the-counter (OTC) of heartburn medication ranitidine products in the form of tablets and syrup from the market for high levels of NDMA.
In November 2019, Amneal had recalled 94 lots of heartburn medication Ranitidine in the form of tablets and syrup for the same issue. It also recalled certain lots of heartburn medication Nizatidine in April for the same issue.
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