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Science Forum Index » Medicine - Nursing Forum » FDA reviewing safety of Botox
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| Ilena Rose |
 Posted: Fri Feb 08, 2008 2:20 pm |
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http://ilenarose.blogspot.com
Health Lover
FDA Notifies Public of Adverse Reactions Linked to Botox Use
Ongoing safety review of Botox, Botox Cosmetic and Myobloc taking
place
The U.S. Food and Drug Administration today notified the public that
Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc
(Botulinum toxin Type B) have been linked in some cases to adverse
reactions, including respiratory failure and death, following
treatment of a variety of conditions using a wide range of doses.
In an early communication based on the FDA's ongoing safety review,
the agency said the reactions may be related to overdosing. There is
no evidence that these reactions are related to any defect in the
products.
The adverse effects were found in FDA-approved and nonapproved usages.
The most severe adverse effects were found in children treated for
spasticity in their limbs associated with cerebral palsy. Treatment of
spasticity is not an FDA-approved use of botulism toxins in children
or adults.
The adverse reactions appear to be related to the spread of the toxin
to areas distant from the site of injection, and mimic symptoms of
botulism, which may include difficulty swallowing, weakness and
breathing problems.
The FDA is not advising health care professionals to discontinue
prescribing these products.
The agency is currently reviewing safety data from clinical studies
submitted by the drugs' manufacturers, as well as post-marketing
adverse event reports and medical literature. After completing a
review of the data, the FDA will communicate to the public its
conclusions, resulting recommendations, and any regulatory actions.
The notification is in keeping with the FDA's commitment to inform the
public about its ongoing safety reviews of drugs. The early
communication, which includes background information and advice for
health care professionals, can be viewed at:
http://www.fda.gov/cder/drug/early_comm/botulinium_toxins.htm |
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