FDA issues adverse reaction warning about Botox

WASHINGTON The Food and Drug Administration has notified the public that Botox, Botox Cosmetic and Myobloc (botulinum toxin type b) have been linked to adverse reactions in patients including respiratory failure and death.

The agency has stated that early indications, based on review of materials, links the reactions to overdosing of the medications and not defects in the products.

The adverse effects were found in FDA-approved and nonapproved products. 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 Botox products in children or adults.

The adverse reactions appear to be related to the spread of the drug to areas distant from the site of injection, and copy symptoms of botulism, which may include difficulty swallowing, weakness and breathing problems.

The FDA is not advising health care professionals to discontinue prescribing these—Allergan and Solstice Neurosciences—products and stated that it is currently reviewing safety information from clinical studies performed by the manufacturers of the drugs.