FDA Issues Botox® Warning

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Consumer Alert: FDA Orders Warning Label for Botox and Similar Drugs

In April 2009, the FDA ordered that Botox and other similar anti-wrinkle drugs must carry the agency’s strictest warning label – the so-called ‘black box’ warning. The move came after reports that such drugs have the potential to move from the injection site and spread to other parts of the body, resulting in serious difficulties, like problems with breathing or swallowing.

“Updated labels for this class of products will help health care professionals and patients better understand the risks and benefits,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Botulinum toxin products have benefits but can cause serious health problems and it is important that anyone who administers or uses these products understands these risks.”

New FDA Requirements

The black box warning was just one of several moves the FDA announced regarding Botox. Manufacturers are also now required to:
Inform users in writing about the potential risk for distant spread at the time of injection.
Warn doctors and patients about the risks associated with substituting one botulism product for another. The products have different dosing units, which are incompatible, so switching products can result in dangerous overdosing.
Follow a group of children and adults using Botox, Myobloc, or Dysport off-label to treat involuntary muscle movement and submit safety data to the agency.

Botox Death

In 2008, the consumer group Public Citizen said it found 16 deaths reported with usage of Botox or Myobloc from November 1997 through 2006. The group filed a petition with the FDA seeking the black-box warning discussing difficulty swallowing, pneumonia as a result of food getting into the lungs and, in rare instances, death from pneumonia.

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