Cafergot Gets A New Black Box Warning From The U.S. FDA. 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 for ‘Cafergot’.
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.
Serious Vasospastic Adverse Events
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.