FDA Approves Botox for Upper Extremity Spasticity

The United States Food and Drug Administration (FDA) has approved Botox® (onabotulinumtoxin A) for the treatment of spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Manufactured by Allergan, Inc., this drug is administered via injection by a medical professional and is available through prescription only.

Spasticity or muscle stiffness and tightness is experienced by many people with multiple sclerosis (MS), stroke, brain injury, or other neurological conditions. Spasticity can severely limit the use of one’s arms and hands as well as produce pain. On March 9, 2010, after evaluating the results of several clinical trials, the FDA approved Botox injections for spasticity in the elbow, wrist, and fingers in adults. The approval includes its use for individuals with MS.

Botox is given by an injection directly into the affected muscles. It blocks conduction between nerves and muscles which temporarily paralyzes spastic muscles, usually for a few months. According to a news release from Allergan, "Botox neurotoxin is expected to diffuse locally and expected to produce a safe and effective result by producing a localized and temporary reduction in the overacting muscle or gland, usually lasting up to approximately 3 to 6.7 months depending on the patient and indication."

This drug was first approved 20 years ago by the FDA for the treatment of certain eye-muscle disorders. Since that time it has also been approved by the FDA to treat three other disorders, which include a condition causing abnormal head position and neck pain; symptoms of severe underarm sweating; and the cosmetic use of temporarily improving the appearance of severe frown lines between the eyebrows.

Allergan notes that Botox has been studied in approximately 11,000 patients over the past 20 years and has been recognized by regulatory authorities worldwide as an effective treatment for 21 different indications in approximately 80 countries. The company estimates that 29 million treatment sessions have been performed during the past 20 years.

Several years ago MSAA conducted a needs-assessment study of more than 700 MSAA clients. The symptom of stiffness or spasms was the 4th most cited symptom (out of 16 categories), with 29 percent being severely affected, and 51 percent being somewhat affected (for a total of 80 percent) during the "past week."

The risks and benefits associated with Botox should be discussed with one’s doctor. The most common side effects include nausea, fatigue, bronchitis, pain, and muscle weakness. Breathing and swallowing difficulties have been reported.

Botox injections add another treatment to the growing list of medications that may help MS symptoms. Botox is a symptomatic treatment only and is not a disease-modifying therapy for MS; it should not be used as a substitute for these therapies. The FDA points out that Botox "is not intended to substitute for physical therapy or other rehabilitative care." Individuals who may benefit from this treatment for spasticity in the elbow, wrist, and fingers should consult their physician for specific recommendations.

Individuals with questions may speak with an MSAA consultant by calling (800) 532-7667 between the hours of 8:30 am and 7 pm (ET) Mondays through Thursdays, and between 8:30 am and 5 pm (ET) on Fridays. Spanish-speaking individuals may contact a bilingual consultant between 9:00 am and 5 pm on weekdays by dialing extension 108.

Written by Jack Burks, MD, MSAA Chief Medical Officer
and Susan Wells Courtney, MSAA Senior Writer & Creative Director