Gen: Group Wants Botox Black Box Warning

From: art fougner, md (evsono@pipeline.com)
Fri Jan 25 06:39:03 2008


Botox and a similar injected drug have been associated with 16 deaths, four of them in children, and scores of serious injuries that occurred after the drug spread to vital organs, a health advocacy group says.

The drug, a neurotoxin that is used to relax muscles, should come with a far stronger warning label and patients should be given a letter detailing its risks, the group, Public Citizen, said in a petition filed Thursday with the Food and Drug Administration.

Julie Zawisza, a spokeswoman for the agency, said she could not comment while the petition was under review.

Executives at Allergan, the maker of Botox, issued a statement saying that adverse reactions were rare. And because many patients who get the drug are seriously ill, the company said, it is not proved that Botox caused the reactions. Solstice Neurosciences, the maker of a similar drug, Myobloc, did not return a message for comment.

http://www.nytimes.com/2008/01/25/health/policy/25botox.html?ref=health

Paging Nancy Pelosi ...

--
art fougner, md
"May The Wings of Liberty Never Lose a Feather." - Jack Burton




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