Call it a distant possible death warning. Prompted by a study suggesting the drug may increase the risk of death, FDA has embarked on a safety review of Maxipime, a Bristol-Myers Squibb antibiotic. For now, the agency isn't recommending any prescribing changes. The review will take about four months. In the meantime, FDA wants healthcare providers to enter any Maxipime side effects into the MedWatch adverse event reporting system.
Marketed in the U.S. by Elan, Maxipime is an injectable used to treat serious infections such as pneumonia. The possible risks were first made public in May, when The Lancet Infectious Diseases medical journal published an article suggesting Maxipime patients were more likely to die than patients treated with other drugs in the same class. The company's own review of the data "concluded that the safety profile has not changed," a spokesman said.
- see the FDA's early communication about the safety review
- read the CNN Money report for more
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