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U.S. Department of Health and Human Services

Safety

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Cafergot (ergotamine tartrate and caffeine)

Audience: Neurologists and other healthcare professionals

FDA and Novartis strengthened the labeling, including a new BOXED WARNING and updates to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY sections of the prescribing information.

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. Because CYP 3A4 inhibition elevates the serum levels of Cafergot, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Because of the increased risk of serious vasospastic adverse events, concomitant use of these medications is contraindicated.

[October 2002 - Letter - Novartis]