FDA: Botox must carry strong risk warning

Washington

- Botox (botulinum toxin type A, Allergan) and similar products must carry a strong warning about the risk of severe complications if the toxin spreads in the body, according to the Food and Drug Administration (FDA).

The agency made the decision following the investigation of deaths and hospitalizations of adults and children treated for medical conditions. Most of the children were treated for cerebral palsy; adults who experienced severe complications were treated for spasticity or cervical dystonia, Reuters reports.

According to the FDA, no definitive serious adverse events related to toxin spread were identified after dermatologic use of Botox at specific approved doses, and deaths reported in adults could not be attributed to the toxin, because the patients also suffered from complications from pre-existing conditions, Reuters reports.

The new warnings, which currently must be carried by Botox, Myobloc (Solstice Neurosciences) and Ipsen’s just-approved Dysport, must be highlighted in a boxed warning.