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Botox & Myobloc: What Are They & Why Has The FDA Issued A Warning?

The Food and Drug Administration (FDA) issued a public warning that Botox, Botox Cosmetic and Myobloc, which are botulinum toxins used cosmetically to reduce wrinkles and therapeutically for other purposes, may be dangerous. But what are these drugs and why has the FDA issued a warning about their use?

Botox: What is it?

Botox is prescribed as Botox, Botox Therapeutic or Botox Cosmetic. According to Allergan, Inc., the manufacturer of Botox:

  • Botox. Botox is indicated for the treatment of severe primary axillary hyperhydrosis (severe underarm sweating) that is inadequately managed by topical agents.
  • Botox Therapeutic. Botox Therapeutic is indicated for the treatment of cervical dystonia (an often painful condition that affects the neck and shoulders) in adults to decrease the severity of abnormal head position and neck pain associated with cervical dystonia. It is also indicated for the treatment of strabismus (a condition in which the eyes deviate, or turn, when looking at an object) and blepharospasm (a condition in which there is sustained, forced, involuntary closing of the eyelids) associated with dystonia including benign essential belpharospasm or VII nerve disorders (a facial nerve disorder) in patients 12 years of age or above.
  • Botox Cosmetic. Botox Cosmetic is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines (the smooth area between the eyebrows just above the nose) associated with corrugator (a muscle near the eyebrow) and/or procerus muscle (a muscle near the nose) activity in adult patients 65 years of age or younger. Source: www.botox.com

Myobloc: What is it?

According to the Myobloc's manufacturer, Solstice Neurosciences:

  • Myobloc is indicated for the treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia. Source: www.myobloc.com

FDA Warning

The FDA issued its warning after Public Citizen, a consumer group, provided the FDA with data that these drugs may have been linked to 180 reports of serious injury and 16 deaths. The national, nonprofit consumer advocacy organization said that it analyzed date from November of 1997 through December 2006 and found that there were 658 reported cases of people suffering adverse effects from injections of botulinum toxin. Of those, 180 cases were associated with aspiration (fluid in the lungs), dysphagia (difficulty swallowing) and/or pneumonia and 87 cases required hospitalization. To see the FDA's warning, go to http://www.fda.gov/bbs/topics/NEWS/2008/NEW01796.html.

Approved FDA Usage

The FDA has approved the drugs for the following uses:

  • Botox. Botox (botulinum toxin type A) is approved for treatment of conditions such as blepharospasm, cervical dystonia and severe primary axillary hyperhydrosis.
  • Botox Cosmetic. Botox Cosmetic (also botulinum toxin Type A) is approved for temporary improvement in the appearance of moderate to severe facial frown lines.
  • Myobloc. Myobloc (botulinum toxin Type B) is approved for the treatment of adults with cervical dystonia; the safety and effectiveness of Myobloc for cervical dystonia in children have not been established.

If you've been injured after using one of these drugs, contact an attorney to discuss your situation. For a free, no-obligation consultation with a qualified attorney whose practice focuses in this area of law, please click here.



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