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

An analysis by U.S. regulators found Bristol-Myers Squibb and Elan Corp’s 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.

Officials at Elan could not immediately be reached.

Elan reported first-quarter revenue of $5 million from Maxipime, a 50 percent drop from a year earlier. The company said the decrease was mainly due to generic competition launched in 2007.

Elan shares fell 2.41 percent to close at $7.30 on the New York Stock Exchange. Bristol-Myers shares gained 2.8 percent to close at $19.92, also on the NYSE.

The FDA notice was posted at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm167427.htm.

WASHINGTON (Reuters)