Ergotamine Tablets

05 October 2007

Products Affected - Description

Discontinued Products:

• Bel-Tabs tablets (Mutual) - discontinued
• Bellamine tablets (Harvard Drug Group, formerly Major) - discontinued
• Bellamine S tablets (Harvard Drug Group, formerly Major) - discontinued
• Belladonna alkaloids, ergotamine, and phenobarbital tablets (Actavis, Ferndale, and various other distributors or repackagers) - discontinued
• Bellaspas tablets (Qualitest) - discontinued
• Bellaspas elixir (Vintage) - discontinued
• Bellergal S tablets (Sandoz, formerly Novartis) - discontinued
• Caffeine, ergotamine, and pentobarbital suppositories (various distributors and repackagers) - discontinued
• Cafatine PB tablets (Harvard Drug Group, formerly Major) - discontinued
• Eperbel-S tablets (Excellium) - discontinued

Reason for the Shortage

Products containing combinations of ergotamine/belladonna/phenobarbital, ergotamine/belladonna/pentobarbital, ergotamine/pentobarbital/caffeine, and ergotamine/belladonna/pentobarbital/caffeine have been discontinued. The manufacturers would not provide a reason for the discontinuations; however, these products are not FDA-approved. In March, 2007 the FDA asked manufacturers to stop marketing these unapproved agents.

Estimated Resupply Dates

Ergotamine/caffeine is the only FDA-approved ergotamine-containing product for headache (Cafergot, generics). Products with other ingredients, such as belladonna alkaloids or barbiturates, are not FDA-approved and therefore cannot be AB-rated.

Updated

October 5, 2007; University of Utah, Drug Information Service

Back to Drug Shortage Product Bulletins