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Article: EP position and perspective on BOTOX[R]: EP Global Communications, Inc. and Exceptional Parent magazine add perspective on the recent FDA public notification concerning adverse events reported in children with celerbral palsy who have received treatment with Botulinum Toxin (BOTOX[R]) injections.(Exceptional Parent, Food and Drug Administration)
- Article from:
- The Exceptional Parent
- Article date:
- April 1, 2008
CopyrightCOPYRIGHT 2008 EP Global Communications, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Recently, the Food and Drug Administration (FDA) expressed concerns about the safety of BOTOX[R] injections to treat spasticity in children with cerebral palsy. It is important to recognize that it has not been established whether these adverse events are causally related to Botox treatment. Notwithstanding the tendency of the media to cast a spin of hysteria on this announcement, it is important to note that the serious adverse events reported occurred in four children with cerebral palsy. The FDA is currently reviewing safety data from clinical studies submitted by the drug's manufacturers, as well as post-marketing adverse event reports and medical literature. It is ...
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