June 27, 2012 — The FDA is warning that the antibiotic cefepime, which is marketed under the name Maxipime, may cause seizures in patients who have kidney impairment when doctors do not reduce the dosage. The FDA was concerned after receiving 59 reported cases of a type of seizure called a nonconvulsive status epilepticus. In 58 of the 59 cases, the patients had kidney problems. In 56 of the 59 cases, doctors did not follow FDA recommendations to lower the dosage.
Sixteen patients died after being given improper dosages of the antibiotic, however, the FDA did not conclude that the drug was the cause of death. However, seizures may have contributed to two of the deaths.
The FDA will force manufacturers to update the warning label on the drug to better inform doctors about the dose guidelines for people who have kidney problems.
The FDA also advised that patients who have a seizure while taking cefepime should probably be switched to another drug or take a reduced dosage.
This recent FDA warning is not the first FDA action on cefepime. In 2007, the FDA announced that they were conducting a safety review about the potential increased mortality in patients treated with cefepime. In 2009, they concluded that there was no increased risk of mortality.
Cefepime is a cephalosporin antibacterial drug that is used to treat pneumonia, urinary tract infections, skin infections, and intra-abdominal infections. It is mostly used in a hospital setting, where it is administered intravenously or injected into a large muscle. The FDA is advising health care professionals to reduce the dosage of cefepime in patients who have impaired kidney function.
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