Drug Notebook

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.

What should I discuss with my healthcare provider before I receive botulinum toxin type A?

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 are allergic to any drugs, or if you have:

  • amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");

  • myasthenia gravis;

  • Lambert-Eaton syndrome; or

  • heart disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive this medication.

Botulinum toxin type A is made using human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

FDA pregnancy category C. Botulinum toxin may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether botulinum toxin passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
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