UPDATE 3-U.S. FDA: No higher deaths with Bristol, Elan drug

Wed Jun 17, 2009 11:52pm BST
 
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* No increased death rate with Maxipime antibiotic-FDA

* FDA reviewing deaths since 2007 (Adds shares, Bristol-Myers comment)

WASHINGTON, June 17 (Reuters) - An analysis by U.S. regulators found Bristol-Myers Squibb (BMY.N) and Elan Corp's (ELN.I) (ELN.N) antibiotic Maxipime was not associated with a higher rate of death compared with similar drugs, the Food and Drug Administration said on Wednesday.

Maxipime "remains an appropriate therapy for its approved" uses, the FDA said in a notice on its website.

The agency said in November 2007 it was reviewing a study that suggested there may be a higher death rate in patients treated with the drug, known generically as cefepime.

"FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients," the agency said in its announcement.

The FDA will continue to review the safety of the drug, the agency said. Separate analyses from the agency and Bristol-Myers are ongoing, and results likely will be reported in one year.

Maxipime is approved to treat pneumonia and other infections. Elan distributes the drug in the United States under a license from Bristol-Myers.

Bristol-Myers said its own analysis also showed no increase in deaths with Maxipime when compared to similar drugs.  Continued...

 

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