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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.

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

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Richard Alexander