FDA Issues Warning About Botox

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The Food & Drug Administration has issued its strongest warning – a “black box” label – against Botox, the popular cosmetic drug used to reduce the appearance of fine lines and wrinkles.

According to the Wall Street Journal, the FDA is warning that Botox injections can lead to serious complications. Though rare, these complications include difficulty swallowing and breathing, and can be a problem if the toxin spreads beyond the injection site.

The FDA will require the warning to be listed on all boxes of Botox injections, and doctors will be required to hand out pamphlets detailing the risks to all patients. Similar drugs will also require the warning, including Dysport, an injectable drug that is also approved to reduce the appearance of frown lines.

The FDA notes that most cases of severe health complications occur with “off-label use,” when Botox injections are used for unapproved purposes. Many doctors use Botox to treat muscle problems in patients with cerebral palsy, which is an example of off-label use.

Fewer complications have been reported concerning Botox treatments for cosmetic use, which is the primary use of Botox Cosmetic.

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