Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) have been associated with undesirable side-effects, including respiratory failure, and on occasions death, says the US Food and Drug Administration (FDA). These adverse reactions can occur after treatment for a range of conditions and dosages.
These reactions may be caused by overdosing, the FDA reports in an early communication based on its ongoing safety review. The Agency stresses that these adverse reactions are not linked to any defect in the products.
Adverse effects have been detected in both approved and non-approved usages. The worst events were reported among cerebral palsy child patients for treatment for limb spasticity – this kind of treatment is not FDA-approved.
It seems the toxin spread far from the injection site and are similar to the symptoms found in botulism, including difficulty swallowing, breathing problems and weakness.
The Agency says it is not advising doctors to stop prescribing Botox products.
A safety data review from clinical studies submitted by drug manufacturers is being currently carried out by the FDA. The agency is also reviewing post-marketing adverse event reports. When the review is complete, the FDA will publish its conclusions, final recommendations, and implement regulatory actions (if they are needed).
It is common for the FDA to issue an early communication, such as this one.
US Food and Drug Administration
Written by – Christian Nordqvist