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Cafergot FDA Alerts

The FDA Alerts below may be specifically about Cafergot or relate to a group or class of drugs which include Cafergot.

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.

Recent FDA Alerts for Cafergot

Cafergot (ergotamine tartrate and caffeine)

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]
[July 2002 Full, Revised Label, changes highlighted - Novartis]

More Cafergot Resources