FDA evaluating risk of death associated with Maxipime antibiotic injection

Carl Saiontz

By Carl Saiontz
Posted November 15, 2007


The FDA issued an early communication yesterday regarding a possible increased risk of death associated with Maxipime, an antibiotic injection used for pneumonia and other serious infections.  The federal drug regulators are reviewing safety data and have requested additional information from the manufacturer to complete a review of the rate of death among patients treated with the antibiotic.

>>FDA LINK: Maxipime Risk of Death

Maxipime for Injection is the brand name for cafeprime hydrochloride.  Bristol-Myers Squibb Company manufactures the antibiotic and it is licensed for exclusive marketing in the United States to Elan Biopharmaceuticals.  It is a broad spectrum B-lactam antibiotic which has been approved for treatment of a variety of serious infections, such as:

  • Pneumonia
  • Empiric therapy for febrile neutropenic patients
  • Uncomplicated and complicated UTIs, including pyelonephritis
  • Uncomplicated skin and skin structure infections
  • Complicated intra-abdominal infections.

Concerns about the Maxipime death risk surfaced after a report was published in the May 2007 issue of the Lancet Infections Diseases.  A meta-analysis reviewed several studies which suggested that the Maxipime death rate was higher than that associated with patients who took other drugs in the same class of medications.

The early communication issued by the federal drug regulators is not an indication that the FDA has reached a conclusion about whether the information warrants additional warnings or other actions by the agency.  They indicate that it will likely take about four months for the FDA to complete their evaluation of the Maxipime side effects, at which time any resulting recommendations will be released to the public.

At this time, the FDA has cautioned healthcare providers to be aware of the Maxipime risks and benefits.  Any side effects of Maxipime should be reported to the FDA’s MedWatch Adverse Event Reporting program at http://www.fda.gov/medwatch/report.htm.  If a friend or family member has died after receiving the injectable antibiotic Maxipime (cafeprime), contact our office to review the potential legal rights which may exist.  Request a free consultation.

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