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Topic: Cafergot/ergotamine & serious drug interaction (Read 325 times) |
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Bob_Johnson
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Cafergot/ergotamine & serious drug interaction
« on: Nov 15th, 2002, 10:54am » |
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Cafergot Plus CYP 3A4 Inhibitor Linked With Fatal Ischemia
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 https://www.accessdata.fda.gov/scripts/medwatch.
The full revised prescribing information is available on the FDA Web site in PDF format at http://www.fda.gov/medwatch/SAFETY/2002/cafergot_PI.pdf.
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"Ischemia" is a serious restriction in blood flow which can lead to organ damage or death.
Protease inhibitors are, for example, ritonavir.
Macrolide antibiotics, e.g., troleandomycin, clarithromycin, erythromycin.
The revised patient information available at the FDA site, above, also notes INDERAL can cause these problems.
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Bottom line: if you are using any of these medications, call this report to your physician's attention and stop using them in the combinations noted here until cleared by your doc.
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Bob Johnson
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Karla
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Re: Cafergot/ergotamine & serious drug interaction
« Reply #1 on: Nov 15th, 2002, 11:10am » |
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Thank you for sharing the news with us. This is very important to some users.
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Karla
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