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Botox & its rivals get a black box warning

Should you have missed this story, you may want to reconsider diving into that Botox fountain of youth ...

In case you missed the most recent news, here’s  The New York Times article “F.D.A. Orders Warning Label for Botox and Similar Drugs,” Botox will now be labeled with a black box warning–“the most stringent kind of warning label,” by the Food and Drug Administration.

“Requiring a drug to carry a box with bold-face risk information – a so-called black-box warning – is one of the strongest safety actions the F.D.A. can take. Black boxes are typically reserved for medications known to have serious or life-threatening risks. Antidepressants, for example, carry black boxes warning of the increased danger of suicidal thoughts and actions,” says NYT author Natasha Singer.

The F.D.A. may have been steered into action after receiving a petition from the public advocacy group Public Citizen, which called for the black boxes to warn of the dangers in Botox migration from the injected site. “Botulinum toxins are proteins produced by a bacterium, Clostridium botulinum. Botulinum toxin acts by blocking the transmission of nerve impulses to muscles, causing those muscles to relax and resulting in a loss of muscle control. In the case of food poisoning from botulinum toxin, in which the toxin spreads widely around the body, early symptoms include dry mouth, difficulty swallowing, slurred speech, drooping eyelids, and muscle weakness. Subsequent paralysis of respiratory muscles can lead to death.

In the case of injected therapeutic or cosmetic use of botulinum toxin, if the product spreads from the injection site to another area of the body, this loss of muscle control can be similarly harmful. For example, when muscle control to the esophagus is lost, one loses the ability to control swallowing; food and drink can then accidentally reflux and be aspirated into the respiratory tract and lungs, causing a serious complication, aspiration pneumonia, and occasionally lead to death.”

Here’s the chart below included in the petition. Yikes! Maybe we should really learn to love our frown lines …

Reaction All cases Total deaths§ (deaths of minors) Hospitalizations†
All cases 180 16 (4) 87
Dysphagia 129 1 (0) 55
Aspiration and/or pneumonia 31 9 (3) 18
Both 20 6 (1) 14
* Only cases reported to the FDA by drug manufacturers are counted. Foreign cases are excluded.
§ One death with the Preferred Term “suicide” was excluded from our count.
† Excluding any cases also marked as deaths

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The New York Times, “F.D.A. Orders Warning Label for Botox and Similar Drugs,” Natasha Singer, April 30, 2009

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2 Comments
Lola Potts says: May 19th, 2009 at 7:53 pm

what about the use of botox for chronic pain, muscle spasm and orthopedic medicine??

Harriett says: May 19th, 2009 at 8:03 pm

Hi Lola,
Suggest you talk with your doctor(s) on those issues as they probably vary for everyone depending on need and condition. Sorry I can’t be more helpful.
Harriett

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