For Immediate Release: March 9,
2010
Media Inquiries: Sandy Walsh, 301-796-4669;
sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
The U.S. Food and Drug Administration today approved Botox
(onabotulinumtoxin A) to treat spasticity in the flexor muscles of
the elbow, wrist, and fingers in adults. Spasticity is common 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 works by temporarily blocking the connections between
nerves and muscles, resulting in a temporary paralysis of the
spastic muscle.
Botox has a Boxed Warning that says the effects of the botulinum
toxin may spread from the area of injection to other areas of the
body, causing symptoms similar to those of botulism. Those symptoms
include swallowing and breathing difficulties that can be
life-threatening.
The most common adverse reactions reported by patients with upper
limb spasticity were nausea, fatigue, bronchitis, muscle weakness,
and pain in the arms.
Botox has not been shown to be safe and effective treatment for
other upper limb muscles, spasticity in the legs, or for treatment
of fixed contracture – a condition that affects range of
motion. Treatment with Botox is not intended to substitute for
physical therapy or other rehabilitative care.
Botox is manufactured by Allergan Inc. of Irvine, Calif.