The FDA announceed Monday it approved a revised — "black box" — labeling warning on Botox Cosmetic, following up on its April 2009 announcement about tougher warnings.
In addition to the boxed warning change for Botox and Myobloc, the FDA said it was changing the generic names for both products to avoid medication errors. The brand names and product formulations are not changing.
The new warnings came after reports of breathing problems and a "handful" of deaths in some patients when Botox or Myobloc were being used for offlabel use. Most of the deaths and serious problems were reported in children being treated for cerebral palsy-associated limb spasticity.
The FDA said it had not received "definitive" reports of distant spread of toxin associated with Botox when used at recommended doses for treating frown lines as well as severe underarm sweating, another use for which the product is approved. The agency also said it’s not received reports involving distant spread of toxin involving Botox when used at approved doses for eyelid twitches or for crossed eyes.
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.
[Source: Dow Jones/AP]