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Senior Citizen Alerts
FDA Notifies Public of Adverse Reactions, Deaths
Linked to Botox Use
Ongoing safety review of Botox, Botox Cosmetic
and Myobloc taking place
 Feb. 8, 2008 - The U.S. Food and Drug
Administration today said 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 part of the 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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