FDA Orders Black Box Warning For Botox Products

The Food and Drug Administration (FDA) is ordering Botox and similar anti-wrinkle drugs carry stringent warning labels, prompted by reports of serious adverse events.

The label changes will include a boxed warning and a Risk Evaluation and Mitigation Strategy (REMS) are necessary for all botulinum toxin products.

Botulinum toxins may spread from the injection area to other areas of the body causing symptoms similar to those of botulism, including trouble of breathing, trouble swallowing, blurred vision and various other adverse effects.

The FDA said Botox and two other injections carry risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

A black box warning is considered the FDA’s most urgent warning and is intended to highlight the dangerous risks associated with a particular drug. The boxed text is displayed more prominently then the text surrounding it and therefore provides a better safety warning to users. Anti-depressants, for instance, carry black box warnings which alert the user to an increased risk of suicidal thoughts and actions.

Botulinum toxins are purified forms of botulism that work to temporarily reduce or stop muscle activity. The FDA approved Botox for use in treating eyelid spasms, crossed eyes, severe underarm sweating and cervical dystonia. Botox is also widely used for muscle-spasm conditions.

This new action for black-box warnings was spurred by a petition from the watchdog group, Public Citizen, last year following a safety analysis of Botox procedures from FDA records covering 1997 to 2006. Altogether there were 658 adverse effects from Botox injections. Among those included potentially life-threatening pneumonia and fluid in the lungs and difficulty swallowing. There were also 16 deaths.

The products required to add the new label and a Risk Evaluation and Mitigation Strategy (REMS) are: Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan; Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and a new FDA-approved product, Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd.

“Updated labels for these products will help health care professionals as well as patients to better understand the associated 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.

“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 FDA approved the drug Dysport, an injectable drug derived from botulinum toxin, just yesterday. Dysport, which has been approved in Europe for many years, will be the first competition to Botox in the United States. #