[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.
BOTULINUM TOXIN TYPE A (BOTT you lye num) is a neuro-muscular blocker.
This medicine is used to treat crossed eyes, eyelid spasms, and severe neck muscle spasms. It is also used to treat excessive underarm sweating.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This medicine is for injection into a muscle. It is given by a health care professional in a hospital or clinic setting.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years old for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
This list may not describe all possible interactions.
Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor for regular check ups.
This medicine will cause weakness in the muscle where it is injected. Tell your doctor if you feel unusually weak in other muscles. Get medical help right away if you have problems with breathing, swallowing, or talking.
This medicine contains albumin from human blood. It may be possible to pass an infection in this medicine, but no cases have been reported. Talk to your doctor about the risks and benefits of this medicine.
If your activities have been limited by your condition, go back to your regular routine slowly after treatment with this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
This list may not describe all possible side effects.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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