Cafergot Plus CYP 3A4 Inhibitor Linked With Fatal Ischemia

November 14, 2002

Medscape Staff Report

Nov. 14, 2002 — Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of Cafergot with potent CYP 3A4 inhibitors, including protease inhibitors and macrolide antibiotics, the U.S. Food and Drug Administration (FDA) reported today. Cafergot is indicated for the treatment of migraine and vascular headache.

CYP 3A4 inhibition elevates the serum levels of Cafergot (a combination of ergotamine tartrate and caffeine), which increases the risk of vasospasm leading to cerebral ischemia and/or ischemia of the extremities. Because of the increased risk of serious vasospastic adverse events, concomitant use of these medications is contraindicated.

In a letter to healthcare providers about its drug, Novartis Pharmaceuticals pointed out changes to the prescibing information for Cafergot, including a new boxed warning regarding the threat of serious and/or life-threatening peripheral ischemia.

Healthcare professionals should report all serious adverse events suspected to be associated with use of Cafergot to Novartis at (800) 448-5938 or to the FDA's MedWatch Reporting System by phone at 1-800-FDA-1088, by fax 1-800-FDA-0178, by mail using the Form 3500 at MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20857; or via the internet at

The full revised prescribing information is available on the FDA Web site in PDF format at

Reviewed by Gary D. Vogin, MD


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