The popular anti-wrinkle Botox has FDA-approval for just one cosmetic application – it can be used to treat wrinkles between the eyebrows. However, the use of Botox for off-label treatments (those treatments that are not approved by the U.S. Food and Drug Administration) may be putting a wrinkle in Allergans $650 million a year business.
Nine dangerous drug lawsuits have blamed Allergan for illnesses and deaths resulting from both on-label and off-label uses of Botox. At the same time, Allegran is suing the FDA for the right to tell doctors about more off-label uses of Botox.
Doctors may prescribe a drug for medically appropriate off-label purposes if it has approved for any use by the FDA. However, many off label uses have not been thoroughly tested. Doctors may have to guess at the appropriate dosage.
Common off-label uses of Botox include: treatment for incontinence, treatment of children with cerebral palsy, injection into the larynx to treat vocal problems, treatment of migraines, and the treatment of wrinkles in areas other than between the eyebrows.
Botox is a weakened version of botulinum toxin. Four-hundredths of an ounce of this toxin is enough to cause the fatal, paralyzing nerve disease botulism in one million people. However, to make Botox the toxin is diluted to the point that it cannot be measured in the bloodstream. Instead, Allergan measures the toxin in units based on how many lab mice die from the dose. A typical injection of Botox Cosmetic contains 20 times the botulinum toxin needed to kill half a test population of lab mice.
Because a human is about 3,000 times larger than a mouse, this dose is not considered dangerous. However, some individual may have shown symptoms similar to botulism after treatment with the drug.
Symptoms of botulism may include:
• Difficulty swallowing or speaking
• Difficulty breathing
• Blurred vision
• Droopy eyelids
• Facial weakness