Wed, Jun-07-06, 00:26
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Registered Member
Posts: 1,854
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Plan: My own
Stats: 194/000/150
BF:Not sure
Progress: 441%
Location: Bay Area
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Extended-Release Metformin Tablets (Fortamet) Linked to Risk for Lactic Acidosis
on Tuesday, June 06 ~ 11:04:55 CDT
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.
http://www.diabetesincontrol.com/mo...rticle&sid=3792
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