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Drug Notebook

Generic Name: botulinum toxin type A

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Botox, Botox Cosmetic
A skeletal muscle relaxant - It is used to treat moderate to severe frown lines on the face
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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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botulinum toxin type A
What is this medicine?What is the price of this medication and similar alternatives?What side effects may I notice from receiving this medicine?How should I use this medicine?What if I miss a dose?What may interact with this medicine?Who should NOT use this medication?What should I watch for while using this medicine?What should I tell my health care provider before I take this medicine?Can I stop taking the medication if I feel better?I am on so many medications; do I have to take them all?Where can I get more information?

What is this medicine?
ONABOTULINUMTOXINA is a neuro-muscular blocker. It is used to treat moderate to severe frown lines on the face.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Botox 100UNIT Solution ALLERGAN1/$609.98 or 3/$1809.87

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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
  • breathing problems
  • changes in vision
  • chest pain or tightness
  • eye pain, infection
  • fast, irregular heartbeat
  • fever, flu-like symptoms
  • numbness
  • speech problems
  • swallowing problems

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • bruising or pain at site where injected
  • drooping eyelid
  • headache
  • nausea
  • sensitivity to light
  • tearing

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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How should I use this medicine?
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. Special care may be needed.

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.

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What if I miss a dose?
This does not apply.

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What may interact with this medicine?

  • aminoglycoside antibiotics like gentamicin, neomycin, tobramycin
  • muscle relaxants
  • other botulinum toxin injections

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.

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Who should NOT use this medication?

  • Hypersensitivity to botulinum toxin type A or any ingredient in the formulation.
  • Infection at the proposed injection site(s).

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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.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • cerebral palsy spasms
  • infection where this medicine is going to be used
  • myasthenia gravis or other neurologic disease
  • nerve or muscle disease
  • an unusual or allergic reaction to botulinum toxin, albumin, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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