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[IPu] Diabetes In Control "Extended Release Metformin Linked to Risk for Lactic Acidosis



 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
5g/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

Learn about the Steps To Health, a program to increase physical activity that
has gone through 8 years of clinical studies to show its effectiveness.
http://www.steps-to-health.org

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