Botox Story Illustrates Danger of Off Label Prescribing

One of my pet peeves—yes, I know, I keep peeves like a crazy old man who keeps hundreds of cats—is off label prescribing. Off label prescribing allows a drug that has been approved for efficacy and safety for one condition, to be used instead to treat a different malady for which it has never been adequately tested. I think it should be illegal as a form of human experimentation, or at the very least, patients should be told as part of informed consent that the treatment is not specifically FDA approved to treat their condition.

Admittedly, some good has come from this. But also some evil, such as this story (perhaps) illustrates of deaths associated with Botox, the drug used in cosmetic procedures to erase wrinkles:

In a public alert issued Friday, the Food and Drug Administration said Botox, along with a similar drug called Myobloc, has been linked to life-threatening symptoms such as strained breathing and severe difficulty in swallowing, which can lead to a form of pneumonia. The FDA is advising doctors to monitor patients for such reactions while it decides whether to strengthen warnings on the drugs’ labels.

Many of the most serious reactions—deaths and hospitalizations—occurred among children treated for cerebral palsy-associated limb spasticity, the agency said. The drugs are not FDA-approved for that use in children or adults.

FDA-approved drugs often have off-label uses, where physicians take medications approved for one disease to treat another. This practice often benefits patients and drug manufacturers, but can increase risks…

Botox and Myobloc are each forms of a toxin produced by bacteria that can paralyze muscles and lead to botulism, a fatal food poisoning. But in small amounts, the injected toxins can calm muscle spasms. A third product, Botox Cosmetic, is FDA-approved to improve the appearance of wrinkles between the eyebrows.

I have always been dubious of purely cosmetic procedures figuring that even an infinitesimal risk of harm isn’t worth the false look of youth. In any event, the propriety of off label prescribing needs some pondering.