Cefepime Seizure Side Effects Lead to FDA Warning

The FDA has issued a warning to health care professionals about the potential risk of seizures from side effects of cefepime, which is an antibiotic that is marketed under the brand name Maxipime.

According to a drug safety announcement issued by the FDA on June 26, the use of cefepime has been linked to reports of a type of seizure known as nonconvulsive status epilepticus.

The seizure problems with cefepime have primarily been seen among individuals with kidney impairment who did not receive appropriate changes in their dosage for their renal function. However, some cases have occurred among patients who did receive dosage adjustments appropriate for their degree of renal impairment.

The FDA indicates that the “Warnings and Precautions” and “Adverse Reactions” sections of the drug’s label will be updated to highlight the risk of cefepime seizure side effects, indicating that doctors should adjust the dosage of the medication among patients with creatinine clearance less than or 60 mL/min and consider stopping the medication if seizures do occur.

Cefepime is a cephalosporin antibacterial drug similar to penicillin that attacks sensitive bacteria. It is used to treat pneumonia, urinary tract, skin, and intra-abdominal infections. It’s administered intravenously through a vein or by injection into a large muscle.

While cefepime is typically administered to individuals who are hospitalized, some patients may continue to receive the drug after they are discharged from the hospital.

Symptoms of a seizure from cefepime may include altered mental status, confusion, and decreased responsiveness. If these side effects are noticed while taking cefepime, the FDA advises that patients should seek medical attention right away.

According to data submitted to the FDA’s Adverse Event Reporting System (AERS) database, at least 59 cases of seizures during cefepime administration were reported between 1996 and February 2012. Just over half of these cases involved individuals who were over 65 years old, and more than two-thirds were female. Renal dysfunction was noted in all but one of the cases, where the status of the individuals kidney function was not known.

In the majority of the cases, the cefepime seizures were reversible and resolved after the medication was stopped or after hemodialysis

An FDA review of case reports and case series in medical literature suggested that patients who experienced signs of neurotoxicity on cefepime were generally over 50 years old, had underlying kidney problems and often did not receive dose adjustments necessary. Underlying central nervous system problems or a prior history of seizures were also seen among some patients.

The FDA previously expressed concerns about potential side effects of cefepime, launching an investigation in 2007 after a study published in the medical journal Lancet Infections Disease indicated that the medications was associated with an increased risk of death compared to similar drugs. However, in June 2009, the FDA completed their analysis of the potential problem and concluded that data did not indicate a higher rate of death with cefeprime patients, concluding that it remains an appropriate therapy for the approved indications.