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Generic Name: botulinum toxin type A

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a skeletal muscle relaxant -

FDA Alerts: Special Alerts:

[Posted 02/07/2008] FDA issued an early communication about an ongoing safety review regarding Botulinum Toxin Type A (Botox and Botox Cosmetic). FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins type A and type B (Myobloc) for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA’s “Early Communication about an Ongoing Safety Review” for Agency recommendations and additional information for healthcare professionals. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#colchicine and http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm.
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What is the most important information I should know about botulinum toxin type A?

Botulinum toxin injections should be given only by a trained medical professional, even when used for cosmetic purposes.

Do not seek botulinum toxin injections from more than one medical professional at a time. If you switch healthcare providers, be sure to tell your new provider how long it has been since your last botulinum toxin injection. Using this medication more often than prescribed will not make it more effective and may result in serious side effects.

You should not receive this medication if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected.

Before receiving a botulinum toxin injection, tell your doctor if you have ALS ( Lou Gehrig's disease), myasthenia gravis, Lambert-Eaton syndrome, or heart disease.

The effects of a botulinum toxin injection are temporary. Your symptoms may return completely within 3 months after an injection. After repeat injections, it may take less and less time before your symptoms return, especially if your body develops antibodies to the botulinum toxin.

Call your doctor at once if you have drooping eyelids, vision problems, severe muscle weakness, or trouble breathing, talking, or swallowing. Some of these effects can occur up to several weeks after a botulinum toxin injection.

What is this drug?

Botulinum toxin type A is made from the bacteria that causes botulism. Botulinum toxin blocks nerve activity in the muscles, causing a temporary reduction in muscle activity.

Botulinum toxin type A is used to treat cervical dystonia (severe spasms in the neck muscles), or severe underarm sweating (hyperhidrosis).

Botulinum toxin type A is also used to treat certain eye muscle conditions caused by nerve disorders. This includes uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes do not point in the same direction.

Botulinum toxin type A is also used to temporarily lessen the appearance of facial wrinkles.

Botulinum toxin type A may also be used for purposes other than those listed here.

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