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Cafergot (ergotamine tartrate and caffeine) Dear Healthcare Professional Letter Oct 2002


This is the text of a letter from Novartis. Contact the company for a copy of any referenced enclosures.




October 2002

Dear Health Care Provider

Novartis Pharmaceuticals Corporation would like to inform you of recent changes to the prescribing information (PI) for CAFERGOT® (ergotamine tartrate and caffeine) Suppositories and Tablets, which include a new BOXED WARNING section related to interactions with potent CYP 3A4 inhibitors as follows:

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. Hence, concomitant use of these medications is contraindicated.

Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities, with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when Cafergot (ergotamine tartrate and caffeine) was coadministered, at least one resulting in death. Because of the increased risk for ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole).

The sections CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and CLINICAL PHARMCOLOGY: Pharmacokinetics: Interactions of the PI have been updated accordingly, see the enclosed revised PI of Cafergot (ergotamine tartrate and caffeine) Suppositories and Tablets for complete prescribing information.

Novartis is committed to providing you with the most current product information available for the management of patients receiving Cafergot (ergotamine tartrate and caffeine). You can further our understanding of adverse events by reporting them.

Health care professionals should report all serious adverse events suspected to be associated with use of Cafergot (ergotamine tartrate and caffeine) to Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey 07936, or phone at (888) 669 - 6682 or the internet at http://www.pharma.us.novartis.com.

Alternatively, this information may be reported 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 the internet at http://www.accessdata.FDA.gov/scripts/medwatch.

Please see the enclosed revised PI Cafergot (ergotamine tartrate and caffeine) Suppositories and Tablets for complete prescribing information. Current and future patients being treated with Cafergot (ergotamine tartrate and caffeine) should be fully informed of the above information.

Alan L. Bess, M.D.
Vice President
Clinical Safety & Epidemiology
Stephen R. Cunningham, M.D., FRCP, FFPM
Vice President
Medical Affairs