Levadex dihydroergotamine regulatory update

EMA's CHMP recommended restricting the use of medicines containing ergot derivatives, including dihydroergotamine, from treating several conditions involving blood circulation problems, problems with memory and sensation or to prevent migraines because the risks are greater than the benefits in the indications. CHMP based the recommendation on a review of available data that showed an increased risk of fibrosis and ergotism with the medicines. Marketing authorization for ergot derivatives that are only indicated for these conditions will be suspended, but ergot derivatives approved for other indications will remain authorized for those indications. CHMP's recommendation will now be sent to the European Commission for the adoption of a legally binding decision throughout the EU. Ergot derivatives included in the review were dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline and the combination of dihydroergocryptine with caffeine. ...