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Botox® (onabotulinumtoxinA)

Botox injections have been extremely common in recent years for those who want wrinkles removed from their faces, and for a time this strategy seemed to work wonders for those who trusted it. These injections were fast, relatively affordable and easily overcome in terms of any lasting effects, most of which were reported merely as minor pain.

Read the complete MedWatch Safety Summary including a link to the FDA’s Early Communication about an Ongoing Safety Review regarding this issue.

Why is Botox prescribed?

Botulinum toxin is used to treat a number of problems including muscle spasticity, reduction of facial wrinkles and to treat disorders of hyperactive nerves including excessive sweating, neuropathic pain, and some allergy symptoms.

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What are the FDA approved uses for Botox?

Botulinum toxin is used to treat a number of problems including muscle spasticity, reduction of facial wrinkles and to treat disorders of hyperactive nerves including excessive sweating, neuropathic pain, and some allergy symptoms.

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What are the side effects of Botox?

Rare but severe side effects include:

arrhythmia, heart attack, respiratory depression, severe allergic reaction., abdominal pain, breathing difficulties, chest pain, facial and/or tongue swelling, feelings of anxiety, hives and/or skin rash, lightheadedness, nausea and/or vomiting, palpitations and sweating.

More frequent, but less severe side effects can include:

bruising and/or tenderness at the injection site, localized pain, paralysis of the wrong muscle group, skin rash, weakness of muscle group beneath the injection site.

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Botox warnings and alerts

The FDA issued an early communication in 2008 about an ongoing safety review regarding Botox and Botox Cosmetic. The FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B 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.

However, recent reports have hit the media involving the reporting of serious side effects as a result of using Botox injections, and these reports were generated by the Ralph Nader-founded consumer advocacy group known as Public Citizen, which tracked 180 reports of problems with Botox to the FDA and found three side effects to be the most serious.

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Botox drug contradictions

Botox is contraindicated in patients who are hypersensitive to any botulinum toxin preparation or to any of the components in the formulation.

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Botox FAQs

Can I file a lawsuit if I have suffered damages from taking Botox?

Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:

  • Past and future medical expenses
  • Past and future pain and suffering
  • Lost wages
  • Loss of future earning capacity
  • Emotional distress

If you or a loved one has experienced any health problems while taking Botox, you should contact your doctor immediately. You may also wish to contact an experienced Botox lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.

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