February 11, 2008
BOTOX® Gets Stricter Warning from FDA
What You Should Know - Click Here

FDA: Public Health Concerns Raised by False and Misleading Advertising of BOTOX®

In a letter dated June 23, 2003, the U.S. Food and Drug Administration (FDA) gave the following warnings to the makers of BOTOX® (Allergan, Inc.):

"We are very concerned that by continuing to promote BOTOX® COSMETIC in a false and misleading manner these materials are raising significant public health concerns."

"...Allergan continues to promote BOTOX® COSMETIC in a way that misrepresents approved indications."

"[Allergan's advertising] minimizes important risks associated with the use of BOTOX® [and] minimizes the data from the clinical trials which document that almost one-half of all BOTOX® COSMETIC subjects exhibited adverse events."   (emphasis added)

This is not the first warning the FDA has issued concerning BOTOX®.  On at least seven other occasions, the FDA has issued letters and/or review memoranda objecting to Allergan's promotional activities.  To view additional exerpts and the full text of three FDA letters, Click Here.

Problems Reported After BOTOX® Injections

Many problems have been reported following injections of BOTOX®. These have included:

• Bell's Palsy (facial paralysis or facial palsy)

• Systemic muscle pain and weakness, including burning or tingling sensations in the arms or legs (may be diagnosed as paresthesia or Guillain-Barre syndrome)

• Severely decreased tear production, resulting in "dry eye" symptoms and potentially permanent cornea damage (may be diagnosed as Sjogrens syndrome)

• Long term muscle paralysis

• Impaired swallowing leading to aspiration, pneumonia, and in rare cases asphyxiation and death

• Pediatric / Adult Deaths

Free Consultation

If you have had a BOTOX® injection, have suffered serious injuries, and would like a FREE & PRIVATE consultation WITH A LAWYER Click Here.

Other Information:

For an adverse event voluntary reporting form concerning BOTOX®, Click Here.

To view FDA warning letters concerning BOTOX®, Click Here.

To read the prescribing information Allergan is required to disclose to doctors, Click Here (PDF).

For links to other published articles on BOTOX®-related problems, Click Here.

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