March 2, 2007
Subject: FDA – MedWatch – Unapproved Ergotamine Products – Twenty Companies Ordered to Cease marketing Unapproved Drug Products Containing Ergotamine tartrate
MedWatch – The FDA Safety Information and Adverse Event Reporting Program
FDA informed healthcare professionals and consumer that the Agency ordered twenty firms to stop marketing unapproved drug products containing ergotamine tartrate. Ergotamine tartrate products are used to treat vascular headaches, including migraines. Unapproved drugs pose real risks to the American public because they have not been subject to FDA review, and the safety, effectiveness, and quality of such products are unknown. This action does not affect FDA-approved products containing ergotamine. Consumers who are using ergotamine products and have questions or concerns are urged to contact their health care provider.
Read the complete MedWatch 2007 Safety summary, including links to the FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01575.html and Warning Letters
http://www.fda.gov/cder/drug/unapproved_drugs/ergotamine_WL.htm regarding this issue at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Ergotamine
