FDA conducts safety review of Maxipime antibiotic

WASHINGTON The Food and Drug Administration is conducting a safety review of the drug Maxipime, an injectable antibiotic made by Bristol-Myers Squibb used to treat serious infections like pneumonia, according to money.cnn.com

The FDA decided to initiate the review after a study from the medical journal The Lancet suggested that patients on the drug had a higher rate of death compared with patients treated with other drugs in the same class of medications, known as B-lactams. The study also shows that patients with febrile neutropenia – a condition marked by fever and a significant drop in white blood cells – had a higher risk of death.

In a statement posted on its Web site, the FDA said it was working with Bristol-Myers “to further evaluate the finding of increased mortality in patients who received cefepime.” The agency also said it wants health-care professionals and patients to report side effects from the use of cefepime to the FDA’s MedWatch adverse event reporting system.

Tony Plohoros, a Bristol-Myers spokesman said, “We have reviewed safety data from our database as well as government databases to determine if there’s a change in the safety profile of cefepime and have concluded that the safety profile has not changed.”

U.S. sales of Maxipime totaled $107 million during the first nine months of 2007, according to Dow Jones.