FDA: No Death Risk Associated with Maxipime Side Effects

The FDA has completed their analysis of potential safety problems with the injectable antibiotic Maxipime, and concluded that available data does not indicate that the drug increases the risk of death.

Concerns about potential side effects of Maxipime surfaced after a May 2007 study was published in the medical journal Lancet Infectious Disease, suggesting that the fatality rate among Maxipime users was higher than that associated with other drugs in the same class.

Maxipime (cefepime) is an injectable antibiotic manufactured by Bristol-Meyers Squibb and distributed by Elan Corp. It was approved by the FDA in 1996 for treatment serious infections like pneumonia.

“The FDA has determined that the data do not indicate a higher rate of death in cefeprime-treated patients,” wrote the FDA in a statement posted on their website June 17, 2009. “Cefepime (Maxipime) remains an appropriate therapy for its approved indications.”

An early communication about the potential Maxipime problems was issued by the FDA in November 2007, indicating that they were reviewing safety data from the study and requested additional information from the manufacturer to complete a review of the rate of death among patients treated with the antibiotic.

Although they originally indicated that the safety review would only take about four months, an update was issued in May 2008 stating that no definitive conclusion had been reached and that they were continuing to review a large number of studies.

In the June 17 update, the FDA indicates that data does not suggest a higher risk of death, but they are continuing to review the safety of the drug. Both the FDA and Bristol Meyers Squib are conducting separate analyses of the potentially Maxipime death risk using hospital drug use data. It is expected that these analysis will likely be reported in about one year.