May 14, 2008--On November 14, 2007, FDA announced that it was reviewing safety data that raised concerns about a potential increased mortality in patients treated with cefepime versus similar drugs noted in a meta-analysis published by Yahav et al. 1, and that FDA had requested additional data from the manufacturer, Bristol-Meyers Squibb (BMS) (Early Communication About an Ongoing Safety Review: Cefepime (marketed as Maxipime). FDA expected its preliminary review to take about 4 months and committed to communicate its conclusions and any resulting recommendations to the public at the completion of its review.
The details can be read here.
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