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)
• Long term muscle paralysis
• Severe and recurring migraine headaches
• Impaired swallowing leading to aspiration, pneumonia, and in rare cases asphyxiation and death
• Systemic muscle pain and weakness, including burning or tingling sensations in the arms or legs (may be diagnosed as fasciculation and/or paresthesia)

Free Consultation

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

For links to other published articles on BOTOX®-related problems, click here.

For Legal Information and Disclaimer, click here.

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