FDA Approves New Warning for Botox

Boxes will carry new message regarding treatment.

The Food and Drug Administration (FDA) approved a new warning on Allergan Inc.'s Botox and a similar product about the possibility of life-threatening breathing and swallowing problems, according to recent reports. This follows an earlier advisement about stronger warnings.

Along with signing off on a boxed warning for Botox and Myobloc, made by Solstice Neurosciences Inc., the agency said it was changing the generic names for both products to avoid medication errors. The formulations and brand names will remain the same.

The FDA said Botox's generic name is onabotulinumtoxinA, after previously being known as Botulinum toxin type A, while Myobloc's name is rimabotulinumtoxinB after previously being called Botulinum toxin type B. Dysport was approved in April with the generic name of abobotulinumtoxinA, said reports.