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Botox Settlements Reported

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Botox, best known as a wrinkle eraser, has been in the news quite a bit of late, but not for anything good. Most recently, Allergan, the maker of Botox, admitted it had illegally promoted the drug for off-label uses. The company has also faced lawsuits over Botox side effects, one of which it recently settled out-of-court.

Allergan pleaded guilty to the marketing charges in settlement agreement with the US Justice Department last month. Federal prosecutors launched the investigation into Allergan when two whistle blowers – a physician and a Botox sales representative – filed a complaint in Atlanta. The company was accused of making it “a top corporate priority to maximize sales of Botox” for unapproved uses between 2000 and 2005, according to documents released by the Justice Department. As part of the plea agreement, Allergan will pay penalties of $600 million.

That same moth, Allegan also reportedly agreed to settle a Botox wrongful death lawsuit filed on behalf of a 70-year-old Texas woman who died in 2008 after receiving 100 units of Botox. Sondra Bryant had received the Botox injections to treat pain in her shoulder. Bryant’s family claimed she was not told about the potential side effects of Botox use before she was injected.

In April 2009, the U.S. Food & Drug Administration (FDA) mandated a black box label for Botox and similar products that warned of the risk of adverse events when the effects of a botulinum toxin injection spreads beyond the site where it was injected. The label revision followed an FDA safety review prompted by reports of adverse reactions that resembled botulism infections in patients receiving the injections. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity.

Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. However, doctors are permitted to use approved drugs in anyway they see fit, though drug makers are legally barred from promoting such use.

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