The FDA finally issued formal black box warnings for BOTOX and three other products containing botulinum toxins (BOTOX Cosmetic, Myobloc and Dysport). These new warnings underscore the potentially harmful spread of these drugs from the injection site to distant parts of the human body, potentially affecting a patient's ability to breathe or swallow.
The agency acted on a 15-month-old petition sent by Public Citizen, spurred by 180 reports of serious health problems and 16 deaths connected to such products. During its investigation, the FDA identified 225 additional reports linked to the spread of the drug beyond the injection site. Many of these side effects were related to off-label uses, primarily the treatment of muscle spasticity in children suffering from cerebral palsy.
On the heels of the black box warnings, the FDA also approved Dysport, a variation of the very same toxin to treat cervical dystonia (a neck problem that may cause severe pain and abnormal head positioning), for sale in America.
FDA.gov August 3, 2009
AboutLawsuits.com August 4, 2009
New York Times April 30, 2009
BOTOX is a trademark of Allergan Inc.
Dysport is a trademark of Medicis Pharmaceutical.
Myobloc is a trademark of Solstice Neurosciences.
BOTOX Cosmetic is a trademark of Allergan Inc.