Extended-Release Metformin Tablets (Fortamet) Linked to Risk for Lactic Acidosis

The FDA approved safety labeling revisions for metformin HCl extended-release tablets (Fortamet, made by Andrx Labs, LLC) to warn of the risk for lactic acidosis associated with metformin accumulation during treatment. The condition is fatal in approximately 50% of cases and may also occur in association with a number of pathophysiologic conditions (including diabetes) or whenever there is significant tissue hypoperfusion and hypoxemia. If metformin is implicated, plasma levels of the drug will generally exceed 5 µg/mL.

According to the FDA, the reported incidence of lactic acidosis in patients receiving metformin is low (approximately 0.03 cases and 0.015 fatal cases/1000 patient-years). No cases of lactic acidosis were reported in more than 20,000 patient-years of clinical trials.

Metformin extended-release tablets are indicated for once-daily use alone or in combination with a sulfonylurea or insulin as an adjunct to diet and exercise in improving glycemic control in patients with diabetes aged 17 years and older.
FDA

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