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Clarity for Consumers on Botox Complication and Death Reports
Date:2/22/2008

NEW YORK, Feb. 22 /PRNewswire-USNewswire/ -- The Physicians Coalition for Injectable Safety has issued a statement offering consumers clarity on the safety of Botox(R) injections after reports of serious complications following treatment with Botox for clinical indications.

"Consumers who have had Botox(R) injections for cosmetic indications or who are considering Botox(R) for cosmetic indications should not be alarmed by recent reports of adverse events, but must put this report into perspective," said Coalition Leader Mark L. Jewell, MD, past president of the American Society for Aesthetic Plastic Surgery. Botox(R) has 6 FDA label approvals including cosmetic indications to treat facial expression lines caused by the contraction of facial muscles. Clinical applications of Botox(R) to treat serious neuromuscular disorders such as cervical dystonia and cerebral palsy are the source of data regarding the reported adverse events. The Botox(R) Cosmetic brand is specifically labeled and approved for cosmetic indications. Myobloc(R) is not approved for cosmetic indications.

"The present concern about adverse events following Botox treatment is focused on cases where botulinum (Botox(R) or Myobloc(R)) was injected to treat very serious neuromuscular disorders and serious medical illness," noted Coalition leader Ira D. Papel, MD, past president of the American Academy of Facial Plastic and Reconstructive Surgery. It is estimated that since 2002, 17 million injections of Botox(R) have been safely administered(1) for cosmetic purposes. A total of only 1031 adverse events have been reported with Botox or Myobloc, and the vast majority are clinical uses in patients with very serious illness. Of the 1031 reported events, 995 were considered by the FDA to be non-serious; serious complications represent one in 16,500 patients. "By comparison, the adverse event rate for aspirin is estimated to be over 300 times higher,(2)" said Dr. Papel.

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SOURCE Physicians Coalition for Injectible Safety
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