Botox and Other Drugs Get New Warning and Generic Names
The FDA announced on August 3, 2009, that they approved a new warning on Allergan Inc.’s Botox and a similar product of the risk of life-threatening breathing and swallowing problems, following up on an earlier announcement about tougher warnings.
In addition to signing off on a boxed warning for Botox and Myobloc, made by Solstice Neurosciences Inc., of Malvern, Pennsylvania, the FDA said it was changing the generic names of each to avoid medication errors. The brand names and product formulations are not changing.
In April, the FDA said it would require the agency’s toughest boxed warning regarding the risk of adverse events when the effects of the toxin or the active ingredient used in the products spread beyond the site where it was injected and a medication guide explaining such risks to patients.
At the time, the agency also approved a comparable product, Dysport, with the same boxed warning. Medicis Pharmaceutical Corp. of Scottsdale, Arizona, markets Dysport in the United States to treat frown lines, and Ipsen based in Paris, will market the product to treat cervical dystonia.
The strengthened warnings were touched off by reports of breathing problems and a “handful” of deaths in a number of patients when Botox or Myobloc were being used for an unapproved, off-label use. Most of the deaths and serious problems were reported in children being treated for cerebral palsy-associated limb spasticity. Neither product is approved for such use in the U.S.
The FDA also 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.
