FDA Orders 20 Unapproved Ergotamine Medications Discontinued

"In addition to the reasons stated by the FDA, it's probably a good thing as ergotamine can lead to medication overuse headache."

Companies have 15 days to respond to the FDA with a discontinuation plan for their products. Manufacturers have 60 days to cease manufacturing of new product, and distributors have 180 days to cease further shipment of existing products. Previously manufactured unapproved ergotamine products may still be found on pharmacy shelves for a short period of time.

Warning letters for ergotamine-containing medications were issued to the following companies for the products listed:

• Actavis Totowa LLC: Bellamine S Tablets, Belladonna Alka Ergotamine and PB Tablets, Bel-Phen-Ergot S Tablets, Bellaspas Tablets, Phenobarbital, Ergotamine, and Belladonna Tablets, and Bellamine Tablets
• Anabolic Laboratories: Bel Phen Ergot S Tablets, Bel-Tabs tablets, Cafatine PB Tabs tablets, Bellamine Tablets, Spastrin Tablets, and Urkaf-PB Tablets
• Bio Pharm Inc.: Migracet-PB Suppositories and Ergocaff PB Suppositories
• Breckenridge Pharmaceutical Inc.: Spastrin Tablets and Bellcomp-PB Suppositories
• Centrix Pharmaceutical Inc.: Ergocaff PB Suppositories
• DRX Pharmaceutical Consultants Inc.: Bellamine S tablets
• DSC Laboratories: Bellcomp PB suppositories
• Excellium Pharmaceutical Inc.: Eperbel S Tablets
• Ferndale Laboratories Inc.: phenobarbital, ergotamine, and belladonna tablets; Bellamine Tablets; and Spastrin Tablets
• IVAX Pharmaceuticals Inc. (formerly Goldline Laboratories Inc.): Bel-Phen-Ergot S Tablets
• Kaiser Foundation Hospitals: Belladonna Alka/Ergotamine and PB (Bellamine S) Tablets
• Lini Inc.: Bell Phen Ergot S Tablets, Bellaspas Tablets, and Bellamine Tablets
• Murfreesboro Pharmaceutical Nursing Supply: Bellamine S Tablets and Eperbel S Tablets
• Nucare Pharmaceuticals Inc.: Bellamine S Tablets
• Qualitest Pharmaceuticals, Inc.: Bellaspas Tablets
• Sandoz Inc.: phenobarbital, ergotamine, and belladonna tablets
• The Harvard Drug Group LLC (formerly Major Pharmaceuticals Inc.): Bellamine Tablets; Cafatine PB Tabs tablets; and caffeine, ergotamine, and pentobarbital suppositories
• United Research Laboratories Inc. and Mutual Pharmaceutical Company: Bel-Tabs tablets
• Vintage Pharmaceuticals Inc.: Bellaspas Tablets

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Sources:

FDA News Release. "FDA Takes Action to Halt Marketing of Unapproved Ergotamine Companies Ordered to Cease Manufacturing and Distribution of Illegal Drugs to Treat Migraine Headaches." March 1, 2007.

Bridges, Andrew. "FDA warns migraine medicine makers." Associated Press. March 1, 2007.

Interview. Dr. John Claude Krusz. March 5, 2007.