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Patients with renal impairment who are taking the antibacterial drug cefepime need to have their dosage adjusted, the FDA reminded clinicians on Tuesday, citing new information on the risk for nonconvulsive status epilepticus in such patients.
The agency has received 59 reports of nonconvulsive status epilepticus in cefepime users with renal impairment, most of whom did not have their dosage adjusted. In most cases, the seizures were reversible and stopped once cefepime was discontinued or after hemodialysis.
To reduce the risk for seizures, the FDA says, clinicians should adjust the dose of cefepime in patients with creatinine clearance at or below 60 mL/minute. If seizures occur, clinicians should consider discontinuing the drug or further adjusting the dose.
The risk for nonconvulsive status epilepticus will be added to the drug's label.