FDA Updates Cefepime Label

The Food and Drug Administration (FDA) warns that the antibacterial drug Maxipime (cefepime) may cause a certain type of seizure in patients with kidney impairment.

The FDA says there have been cases of a seizure called nonconvulsive status epilepticus linked to the use of Maxipime, mostly in patients with renal impairment who did not receive appropriate dosage adjustments of the drug.

The agency is ordering that the drug’s warning label be revised to highlight this risk in patients with renal impairment.

From the time of its 1996 approval, the FDA has received 59 reports of nonconclusive status epilepticus during Maxipime administration. In 56 of the 59 patients, Maxipime dosing was not properly adjusted for renal impairment as recommended by the label.

Maxipime is used to treat pneumonia, urinary tract, skin, and intra-abdominal infections, according to an FDA press release.

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