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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May 8, 2009
10:57 am
having trouble with my left eye and face after botox injections
May 11, 2009
3:03 pm
My right eye is always red and inflamed. My opthamologist has diagnosed severe dry eye. As a result, I have to use eyedrops at least once every hour, and the heavy greasy oily stuff at night. I am due for Botox, however, I am concerned about what I am reading regarding this treatment.
May 16, 2009
7:46 pm
Hi,
My BOTOX went fine no side effects with the exception of droopy hooded eyelid area…Had the prodedure done 5 days ago. Every website indicates that this is a temporariy side effect but doesn’t indicate how long it will last??
Sincerely Sally
May 31, 2009
1:28 pm
Are there similar risks associated with restylane and radiesse? Thanks.