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06/05/2009 - News

Botox Gets Boxed Warning

By: June Chen, MD

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Last week, the U.S. Food and Drug Administration (FDA) notified manufacturers of botulinum toxin products that they need to add a boxed warning about the risk of serious side effects that may occur when the effects of the toxin spread beyond the injection site.

 

The FDA issued an order that Botox and other similar anti-wrinkle drugs must carry warning labels explaining that botulinum toxin has the potential to spread from the injection site to other parts of the body. This spread is associated with the risk of serious complications, such as difficulty with swallowing or breathing, and even death. In addition to adding this boxed warning, manufacturers of these drugs will be required to develop and implement a risk evaluation and mitigation strategy to ensure that the benefits of these products outweigh the risks of using them.

 

Most of the reports of distant spread of botulinum toxin’s effects have occurred in cases where the drug was used off-label to treat muscle spasm. However, the FDA alerts healthcare professionals to be sure that they understand that different botulinum toxin products come in different strengths. Patients also need to be educated about the potential side effects of these products and be advised to seek immediate medical treatment if they experience any symptoms, such as muscle weakness, difficulty speaking, loss of bladder control, trouble breathing or swallowing, drooping eyelids, or vision changes.

 

Source: FDA News Release. April 30, 2009.

Created on: 05/05/2009
Reviewed on: 06/05/2009

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