FDA requires strong ’black box’ warning for Botox, others

May 1, 2009

Botulinum toxin products must carry a strong "black box" warning on potentially lethal risks, the U.S. Food and Drug Administration (FDA) announced April 30.

Washington - Botulinum toxin products must carry a strong "black box" warning on potentially lethal risks, the U.S. Food and Drug Administration (FDA) announced April 30. The warning applies to Botox (Allergan), Myobloc (Solstice Neurosciences) and Dysport (Medicus, Ipsen.)

The move follows reports of deaths of adults and children treated with botulinum toxin for medical conditions, according to a report at uk.reuters.com.

While serious complications have resulted from unapproved uses of botulinum toxin, no definitive reports of serious harm have been seen when the injections are given for cosmetics purposes, such as smoothing wrinkles between the eyebrows, officials say.