FDA Warning

Agency Requiring Label Changes for Botox Products

By News Staff
5/7/2009

The FDA is requiring safety label changes -- including a boxed warning -- and a risk evaluation and mitigation strategy for all botulinum toxin products.

FP Greta McLaren, M.D., injects a cosmetic filler into an FP volunteer during a workshop at the 2005 AAFP Scientific Assembly in San Francisco.

The agency said it took the action because of reports that the effects of the products may spread from an injection site to other parts of the body. This distant spread can cause symptoms such as muscle weakness, hoarseness or trouble talking, trouble speaking clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision, and drooping eyelids.

The FDA said symptoms primarily have been reported in children with cerebral palsy who were being treated for muscle spasticity, which is an unapproved use of botulinum toxin. Symptoms also have been reported in adults receiving the drug for both approved and unapproved uses.

The agency is requiring manufacturers to collect safety data in children and adults with muscle spasticity.

Four products are being required to make label changes:

Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan;
Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and
Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd.

The FDA said Botox, Myobloc and Dysport are approved for the treatment of cervical dystonia. Botox Cosmetic and Dysport are approved for dermatologic use in temporarily improving the appearance of glabellar lines. In addition, Botox is approved for the treatment of primary axillary hyperhidrosis, strabismus and blepharospasm.

According to FDA officials, no definitive serious adverse events have been reported when botulinum toxin products have been used to treat glabellar lines in accordance with the approved label.

In requiring the label changes, the agency said it wanted to highlight the potential for serious risks associated with the lack of interchangeability among licensed botulinum toxin products.

"Updated labels for this class of products will help health care professionals and patients better understand the risks and benefits," said Russell Katz, M.D., director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, in an April 30 news release. "Botulinum toxin products have benefits but can cause serious health problems, and it is important that anyone who administers or uses these products understands these risks."

The agency urged physicians who provide botulinum toxins to follow these steps:

understand that dosage strength expressed in units is different among the products, and clinical doses expressed in units are not interchangeable from one product to another;
be alert to and educate patients and caregivers about the potential for adverse effects;
understand that these effects have been reported as early as several hours and as late as several weeks after treatment; and
advise patients to seek immediate medical attention if they develop any of these symptoms.

Physicians and patients may report serious adverse events or product quality problems to the FDA's MedWatch Adverse Event Reporting Program online or by calling (800) 332-1088.

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