FDA Warns of Cefepime Seizure Risk

June 27, 2012 — The FDA has issued a new public safety warning about the risk of seizures associated with cefepime (Maxipime), a type of antibiotic. Between 1996 and 2012, a review of the FDA adverse event database found 59 cases of seizures in people with impaired kidney function who had been given improper dosages of cefepime. The FDA had previously recommended that health care professionals reduce the dosage of the drug for patients with impaired kidney function, but nearly all of the cases occurred in patients who were given improper dosages. The FDA will be updating the label on cefepime to make the recommendation more clear.

 

Cefepime is a type of antibiotic in the cephalosporin class, which is used primarily in the treatment of pneumonia and infections of the urinary tract, skin, and intra-abdominal region. It is mostly administered in a hospital, given intravenously or injected into a large muscle.

Unfortunately, if normal doses of cefepime are given to a patient with impaired kidney function, the patient could suffer a type of seizure called a nonconvulsive status epilepticus.

Of the 59 patients who suffered this seizure after being given cefepime, 58 of the patients had kidney problems, and 56 of the patients received improper dosages of the drug. Sixteen of the patients died, but the FDA stopped short of saying the deaths were caused by cefepime. In two of the deaths, however, the FDA said that cefepime-induced seizures may have played a role.

The FDA will update the warning label on cefepime to better inform health care professionals about the risk of seizure if they do not lower the dosage for patients who have impaired kidney function.

The FDA also recommended that doctors should be aware of the risk of seizures with cefepime. If a patient has a seizure while taking the drug, the doctor should consider switching them to another antibiotic or reducing the dosage.

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