April 30, 2009
FDA To Require Black Box Warning For Botox
U.S. regulators warned consumers and doctors on Thursday about potentially deadly complications that can arise from off-label use of Allergan Inc.'s Botox and similar drugs.
The U.S. Food and Drug Administration (FDA) said the wrinkle-smoother Botox and two other injections carry risks of rare botulism symptoms, especially when given to children to treat muscle spasms.Botulinum toxin can paralyze or relax muscles. Although the drug is perhaps best known for its use as a wrinkle smoother, it is also used to treat conditions ranging from underarm sweating to neck spasms.
In some cases, the toxin can spread to other parts of the body, causing complications such as troubles breathing or talking, muscle weakness, blurred vision and loss of bladder control, the agency said.
Rare hospitalizations and deaths have been reported in adults and children treated with botulinum toxin for medical conditions, officials said.
"Botulinum products have benefits but also can cause serious problems so it's important that anyone who administers or receives these products understand the risks involved," said Dr. Ellis Unger, the FDA's acting deputy director, told reporters.
"The hospitalizations are very few. Deaths are very rare, but they have been reported," Unger said.
Unger noted that no conclusive reports of serious harm have been seen with injections given at approved doses for cosmetic applications, such as smoothing forehead wrinkles.
The FDA called for "black box" warnings, the strongest type for prescription drugs, for three approved botulinum toxin products "“ Allergan's Botox, Myobloc from Solstice Neurosciences Inc. and Medicis Pharmaceutical Corp, and Ipsen's Dysport.
Ipsen announced the approval of Dysport earlier on Thursday, and said the agency had requested the boxed warning, according to a Reuters report.
The FDA said that most reports of harm in children involved the unapproved use of the drugs as treatment for cerebral palsy.
The majority of complications seen in adults followed use of the products to treat spasticity and cervical dystonia, both unapproved uses of the drugs.
However, the agency said it could not definitively attribute any of the deaths in adults to botulinum toxin because the patients also had complications from other conditions.
In a statement, Allergan said it would work with the FDA to update its Botox label.
The FDA said it will require doctors to distribute patient-friendly guides describing the risks.
Sales of the Botox topped $1.3 billion last year.
Shares of Allergan shares fell 1.3 percent on Thursday, closing at $46.66 on the New York Stock Exchange.
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