FDA reviewing safety of Botox

The Food and Drug Administration is reviewing the safety of Botox and related drugs after receiving reports of respiratory failure and death in a small number of people treated with the medications.

The most serious cases involve off-label uses of the drugs in children. And the maker of Botox is now being investigated by the U.S. Department of Justice for inappropriate promotion of off-label uses. But the FDA says that there have been at least a few reports in adults who got the shots for cosmetic or other approved purposes.

Botox and related drugs use very low doses of botulinum toxin, a powerful natural poison, to paralyze overactive muscles. The shots are approved to treat not only wrinkles but also neck spasms, excessive sweating, crossed eyes, and certain other conditions. Some doctors also use the toxin, without FDA approval, for problems such as spasticity in the legs and arms.

Doctors have long known that in people who have pre-existing neuromuscular disorders the shots can trigger effects far from the injection site, including difficulty swallowing and breathing. The new reports suggest that those effects may occur in other people too. The FDA says that to date only a "small" number of hospitalizations or deaths have been reported to the agency, but there may be unreported cases. The FDA is considering a new warning for all botulinum-containing drugs, including Botox, Botox Cosmetic, and Myobloc.

Here's how to protect yourself:

• People taking or considering Botox for cosmetic reasons should think about the potential risks.


• Those taking or considering Botox or related drugs for medical reasons, especially off-label ones, should make sure that their doctor has considered alternatives. If the shots are necessary, ask your doctor to use the lowest effective dose.


• People taking the drugs for any reason should contact their doctor if they experience any of these warning signs: difficulty breathing, talking, or swallowing; muscle weakness; and shortness of breath.

This article first appeared in the May 2008 issue of Consumer Reports On Health