Botox has been approved by the U.S. Food and Drug Administration for the treatment of increased muscle stiffness in the elbow, wrist, and fingers in adults with upper limb spasticity, a condition that may occur following a spinal cord or traumatic brain injury or in patients affected by multiple sclerosis or adults with a history of cerebral palsy.
Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis, and can make performing daily activities difficult.
This debilitating condition impacts approximately 1 million Americans, many of whom suffer from spasticity in the upper limbs following a stroke.
Botox more than just a miracle wrinkle eraser
Botox or BTXA, as it is called in medical parlance, is now approved by the FDA to treat adults with spasticity in the flexor muscles of the elbow, wrist, and fingers.
The FDA said Tuesday that it approved Botox, a popular drug sold by Allergen Inc., to treat spasticity in the flexor muscles, a condition make the muscles stiff and painful, affecting patients' daily activities.
"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."
According to the agency, Botox works by temporarily blocking the connections between nerves and muscles, thus temporarily paralyzing the spastic muscle.
Botox contains box warning
Botox carries a strong warning indicating that the drug is produced from the same bacterium that causes botulism and the effects of the drug may spread from the injection site to other parts of the body, causing life-threatening symptoms including swallowing and breathing difficulties.
The FDA has stressed that Botox hasn't been proven effective in treating similar problems in other upper-limb muscles, including spasticity in the legs, or for treatment of fixed contracture, and it isn't meant to substitute for physical therapy or other rehabilitative care.
"Upper limb spasticity can manifest weeks, months or even years after the original injury, possibly after a patient has stopped seeing a neurologist, physiatrist or their rehabilitation specialist, which is why it is severely undertreated and there's a low awareness of the condition," said Mitchell F. Brin, MD, Allergan's Senior Vice President Global Development, Chief Scientific Officer, BOTOX.
"The approval of BOTOX marks another important evolution in medical care, as we look to raise greater recognition and understanding of upper limb spasticity among patients affected by the condition, and refer them to a neurologist or physiatrist to explore their various treatment options."
About Botox
Botox (botulinum toxin type A) is a neurotoxin protein produced by the bacterium Clostridium Botulinum. It is one of the most poisonous naturally occurring substances.
The most common use of Botox is known to almost all of us. Doctors use the drug to smooth facial wrinkles by paralyzing the muscles that cause them to form.
Apart from treating facial wrinkles, Botox is also used to treat other ailments including cervical dystonia or rigid neck muscles, migraine headaches, uncontrollable blinking, crossed eyes, excessive underarm sweating as well as certain pain disorders and several other disorders that cause repeated muscle twitching.
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