Off-Label Ergotamine Migraine Therapies
The FDA has become more active in going after illegal marketing of off-label migraine drugs. Ergotamine, is a vasoconstrictor that comes from ergot, a rye fungus. There are many variations of this product being sold today. The FDA is warning that ergotamine-based derivatives should not be used with CYP3A4 inhibitors, such as mcarolide antibiotics (erythromycin, troleandymycin, clarithromycin), HIV protease or reverse transciptase inhibitors (ritonavir, nelfinavir, delvirdine) and antifungals.
Other less potent inhibitors include clotrinazole, fluosetine, fluvoxamine, saquinavier and grapefruit juice. CYP3A4 is a metabolic enzyme that affects drug elimination.
There are 5 ergotamine-containing products that are approved for marketing in the US: Cafergot tablets, Ergotamine tartrate with caffeine tablets, Ergomar sublingual tablet, Migergot suppository. These products are labeled for treating vascular headaches/migraines.
Ergotamine products are often coupled with anti-emetics because of side effects. Overuse often leads to rebound headaches. Neurologists are less likely to revert to oral ergotamine therapies and may opt for IV or IM dihydroergotamine for intractable migraine.
Patients seeking this type of information can contact the neurologists for further information. Feel free to contact us with questions:
gizell.larson@neurosciencegroup.com susan.hibbs@neurosciencegroup.com
steven.price@neurosciencegroup.com lisa.kokontis@neurosciencegroup.com
thomas.mattio@neurosciencegroup.com