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Wednesday 28 July 2004
FDA Safety Labeling Changes
The U.S. Food and Drug Administration (FDA) approved in May revisions to drug safety labeling to advise healthcare professionals of the following changes: fondaparinux sodium injection is contraindicated in low-weight patients and is associated with risk of hemorrhage and thrombocytopenia; amiodarone HCl is contraindicated in sinus bradycardia and AV block; use of methocarbamol injection is cautioned in patients with renal impairment; nevirapine is associated with hepatotoxicity; bivalirudin is associated with thrombus formation in brachytherapy.
On May 4, the FDA approved safety changes to the labeling for methocarbamol injection USP (Robaxin Injectable, made by Baxter Healthcare Corp.) to reflect the warning that the ingredient polyethylene glycol 300 may increase preexisting acidosis and urea retention in patients with renal impairment.
More information may be obtained by contacting Baxter Healthcare at 1-800-422-9837.
Methocarbamol is indicated for use as an adjunct to rest, physical therapy, analgesics, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.