FDA Warns Public About Botox and Myobloc Use

The Food and Drug Administration (FDA) has issued a warning over the continued use of Botox, Botox Cosmetic and Myobloc after learning that the drugs may have been linked to respiratory failure and death. The FDA has said that it is currently reviewing safety data from clinical studies submitted by manufacturers as well as post-marketing adverse event reports and the medical literature.

FDA responds to consumer group study

The FDA warnings came two weeks after the consumer group, Public Citizen, revealed that botulinum toxins, used cosmetically to reduce wrinkles and therapeutically for other purposes, have been linked to 180 reports of serious injury and 16 deaths. The toxins are sold as Botox, Botox Cosmetic and Myobloc. The national, nonprofit consumer advocacy organization said that it analyzed date from November of 1997 through December 2006 and found that there were 658 reported cases of people suffering adverse effects from injections of botulinum toxin. Of those, 180 cases were associated with aspiration (fluid in the lungs), dysphagia (difficulty swallowing) and/or pneumonia and 87 cases required hospitalization.

Warning details

According to a February 8th 2008 press release, the FDA has notified the public that Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been linked in some cases to adverse reactions, including respiratory failure and death, following treatment of a variety of conditions using a wide range of doses. The press release provided the following details:

• In an early communication based on the FDA's ongoing safety review, the agency said the reactions may be related to overdosing. There is no evidence that these reactions are related to any defect in the products.
• The adverse effects were found in FDA-approved and nonapproved usages. The most severe adverse effects were found in children treated for spasticity in their limbs associated with cerebral palsy. Treatment of spasticity is not an FDA-approved use of botulism toxins in children or adults.
• The adverse reactions appear to be related to the spread of the toxin to areas distant from the site of injection, and mimic symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.

While the FDA hasn't advised healthcare professionals to discontinue prescribing the products, it said that it is reviewing safety data from clinical studies submitted by the drugs' manufacturers, as well as post-marketing adverse event reports and medical literature and will comment further on the matter. To see the FDA's warning, go to http://www.fda.gov/bbs/topics/NEWS/2008/NEW01796.html.