FDA Reports Botox Linked to Serious Illness and Death

February 2008

The U.S. Food and Drug Administration (FDA) has warned the public of adverse reactions linked to anti-wrinkle drug Botox and its competitor Myobloc. Cases of severe reactions, including respiratory failure and death, have been reported.

It is believed that in rare cases botulinum toxin, used in both Botox and Myobloc, spreads away from the injection site. This spreading results in problems such as paralysis of the respiratory muscles and difficulty swallowing. The most severe adverse effects were reported in children with cerebral palsy being treated for limb spasms, though the FDA does have reports of adverse side effects in those who were given the drug for a variety of conditions.

The FDA is currently evaluating data compiled about the drugs’ safety and will inform the public of its conclusions and recommendations. This current warning comes two weeks after the consumer advocacy group Public Citizen petitioned the FDA to strengthen consumer warnings about Botox and Myobloc.