Off Label

Most of you are familiar with BOTOX® as a cosmetic drug to reduce wrinkles. Small injections of BOTOX® reduce muscle activity by blocking nerve impulses that cause excessive muscle contractions. BOTOX® also blocks nerve impulses causing hyperactive glandular activity, which is why BOTOX® can be used for excessive perspiration. The FDA approved the use of BOTOX® for cosmetic use to reduce wrinkles of the forehead in 2002. Before that BOTOX® had been approved for treatment of strabismus (eye muscle problems) and blepharospasm (spasms of the eyelids) back in 1989. Finally, in 2010, BOTOX® was FDA approved for preventing migraine headaches in adults. Research is continuing on BOTOX®, in fact, BOTOX® has been dubbed a “miracle drug” by some.

As the research continues, some doctors have used the drug “off label,” meaning in ways that have not specifically been approved by the FDA, such as in the case of excessive perspiration mentioned above. About 20% of medications prescribed to adults are off label. For instance recently, a bold and successful usage of BOTOX® that had been splashed across the media involved singer John Mayer. A combination of surgery and BOTOX® injections allowed Mayer to rest his vocal cords and heal from constant stress, drinking, and acid reflux. A University of Michigan study found that BOTOX® helped patients with spasmodic dysphonia, or spasms of the vocal cords, however no long term data is available. The FDA has not approved BOTOX® for this usage yet, however, in Mayer’s case, this seems to be working well. Interestingly, some cosmetic surgeons are offering controversial BOTOX® breast lifts! BOTOX® is injected into the pectoralis minor chest muscle, and this forces the back muscles to compensate by lifting the breast. However, this is controversial and many surgeons believe it is a waste of money, and working on one’s posture would help just at much. I agree.

In other cases “off label” uses are not always successful. There have been incidents when BOTOX® has been used for children’s spasticity, sometimes causing debilitating injuries such as respiratory failure. It is legal for physicians to prescribe BOTOX® for “off label” uses. What is illegal, is for drug companies to market a drug for off label uses. Every day physicians weigh the risks against the benefits when it comes to using a drug off label. Some illnesses are so debilitating in themselves that prevention of the symptoms outweigh the risks and must be treated. In fact, BOTOX® is commonly used for Facial tics, voice disorders and stuttering, urinary incontinence, piriformis syndrome (a neuromuscular disorder of the the sciatic nerve), thoracic outlet syndrome, Parkinson’s disease, myofascial pain syndrome, ischemic digits (ulcers on the fingers or toes), and involuntary muscle movements. What is critical is that the physician explain the risks when using a drug off label.

Off label use of BOTOX® to reduce symptoms of an illness, disability, or disease often works when there is no other solution in sight. So if you were wondering why John Mayer had BOTOX®, it was not about vanity. So, is BOTOX® a miracle drug? Quite possibly, but more research is required in order to prove that. BOTOX® is offered at Little Rock Cosmetic Surgery Center cosmetically and for off label uses when deemed appropriate.

Dr. Branman

Call Melinda at the front desk to set up your consultation with me. 501-277-0707