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Title: Drug interaction warning:ergotamine & dihydroergot Post by Bob_Johnson on Mar 8th, 2003, 9:38am New Contraindications for Medications Containing Ergotamine and Dihydroergotamine Novartis is cautioning physicians and patients about the risk of stroke and/or gangrene when medications containing ergotamine or dihydroergotamine are taken at the same time as certain antibiotic, antiviral and antifungal drugs. DORVAL, QC -- February 18, 2003 -- Following discussions with Health Canada, Novartis Pharmaceuticals Canada Inc. has informed physicians and pharmacists, through a Dear Health Professional Letter, that prescription products containing ergotamine (er-go-tah-meen) or dihydroergotamine (dye-hi-dro-er-go- tah-meen) must not be taken with drugs that can cause the amount of ergotamine in the body to rise to toxic levels. This new CONTRAINDICATION applies to the following Novartis products: Used as Migraine Therapy: - MIGRANAL® (dihydroergotamine mesylate) nasal spray - DHE (dihydroergotamine mesylate injection USP) injectable - CAFERGOT® (ergotamine tartrate and caffeine) suppositories and tablets - CAFERGOT-PB® (ergotamine tartrate, caffeine, belladona alkaloids and pentobarbital) suppositories Used for symptoms associated with menopause: - BELLERGAL® Spacetabs® (belladonna alkaloids, ergotamine tartrate and phenobarbital) tablets These five products must not be taken at the same time as drugs that strongly inhibit certain liver enzymes ("CYP 3A4" enzymes) because the breakdown of ergotamine in the body is slowed down by these drugs. This can lead to high levels of ergotamine in the body, which can cause serious decreases in blood flow to the brain or to the limbs (known as vasospasm or ischemia). Cases of stroke and gangrene have been reported from ergot toxicity, with some cases resulting in death or amputation. Patients should be aware that the symptoms of a blood flow problem include: persistent numbness or tingling in the fingers or toes; ice-cold limbs; muscle pain, cramps and/or weakness in the arms or legs. Patients should contact their physician immediately, or go to the hospital, if one or more of these symptoms develops. Examples of drugs that are strong "CYP 3A4" liver enzyme inhibitors include: - Protease inhibitors used in the treatment of HIV such as ritonavir, nelfinavir, indinavir, saquinavir, - Macrolide antibiotics such as erythromycin, clarithromycin - Antifungal agents such as ketoconazole, itraconazole, fluconazole, clotrimazole There are additional medications and products which are not CONTRAINDICATED, but which may also pose a potential risk of ischemia when taken with ergotamine-containing products; these include: - Several anti-depressant medications, such as nefazodone, fluoxetine and fluvoxamine, as well as grapefruit juice. These lists are not exhaustive, and therefore patients and their doctors should consider the effects of taking other drugs (including prescription, over-the-counter and alternative) at the same time as products containing ergotamine or dihydroergotamine. In addition, products containing ergotamine or dihydroergotamine should not be taken every day, nor taken to prevent symptoms. Novartis has sent a health care professional letter to Canadian physicians and pharmacists informing them of these important new contraindications associated with BELLERGAL® Spacetabs®, CAFERGOT®, CAFERGOT-PB®, DHE® and MIGRANAL® to enable them to optimally counsel patients. The Product Monographs for these drugs will be revised to reflect the above changes, and will also be expanded to provide additional background information. ---------------------------------------------------- If you have concerns about these interactions, you can ask your pharmacist to review your meds, showing this report to him/her. --BJ |
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