FDA: No Death Risk With Bristol-Myers Antibiotic
The Associated Press
06/17/09 - 01:04 PM EDT
WASHINGTON (AP) The Food and Drug Administration told physicians Wednesday that Bristol-Myers Squibb's Maxipime is safe for use, after reviewing data suggesting the antibiotic might increase patients' risk of death.
The FDA began examining the drug's safety in 2007 after a medical journal analysis detected a higher risk of death among patients taking Maxipime compared with other antibiotics.
In a letter to physicians posted online, the FDA said its review included additional data not included in the medical journal, and did not uncover a higher risk of death.
Maxipime is approved to treat pneumonia and other types of infections. The injectable drug is marketed in the U.S. by Elan Pharmaceuticals and elsewhere by Bristol-Myers Squibb.
Shares of New York-based Bristol-Myers Squibb Co. rose 73 cents, or 3.8 percent, to $20.11 in afternoon trading, while Ireland-based Elan Corp. sank 21 cents, or 2.8 percent, to $7.27.