FDA Approves Botox for Elbow, Wrist, Fingers
Yesterday, the U.S. Food and Drug Administration approved Botox (onabotulinumtoxin A) for spasticity treatment in flexor muscles of the elbow, wrist, and fingers in adults. Spasticity often occurs after stroke, traumatic brain injury, or the progression of multiple sclerosis.
“Muscles affected by spasticity have increased stiffness and tightness, which may lead to pain, difficulties with hygiene and other activities of daily living, and may affect how a patient looks,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “In clinical trials, treatment with Botox was found to be beneficial to patients with upper limb spasticity.”
Botox blocks the connections between nerves and muscles for a brief time, producing temporary paralysis of the spastic muscle.
Botox has a Boxed Warning that says the effects of botulinum toxin could spread from the injection area to other parts of the body, causing symptoms similar to those of botulism. Those symptoms include potentially life threatening swallowing and breathing difficulties and even death. Usually, these dangerous conditions have been reported in children with cerebral palsy who were being treated with the botulinum toxin for muscle spasticity, but symptoms have also been reported in adults treated for both approved and unapproved uses.
Most common adverse reactions reported by adult patients were nausea, fatigue, bronchitis, muscle weakness, and pain in the arms.
Interestingly, Botox has not proved safe and effective treatment for other upper limb muscles, spasticity in the legs, or for use affecting range of motion, called fixed contracture. The FDA reminds patients that Botox is not a substitute for physical therapy or other rehabilitative care.
Posted on Wednesday, March 10th, 2010 at 2:05 pm under 