World Pharma News - FDA Notifies Public of Adverse Reactions Linked to Botox Use

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FDA Notifies Public of Adverse Reactions Linked to Botox Use

Posted by worldpharmanews 283 days ago (http://www.worldpharmanews.com)
Category: Research & Development | Tags: fda botox

The U.S. Food and Drug Administration 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.
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