"How does one justify balancing the risk of fatal liver failure against one day less of ear pain?" Dr. Rosemary Johann-Liang, an official in the FDA's Office of Drug Safety at the agency, wrote in an internal memorandum, a copy of which was obtained by The New York Times.
So, finally, Sanofi Aventis stop the paediatric trials of Ketek.
Exactly, Dr Johann-Laing!
Another "local heroine", just like Jennifer Hrachovec, perhaps?
Or, maybe one of the many "lions" in the FDA being led by "donkeys"!
2 comments:
While Ketek might not be the best choice for otitis media, it's certainly not a bad drug. Statistically, even.
hmmmm...risk of liver failure in kids a true concern? That's odd, last I looked we were still giving our kids, zithromax and biaxin and augmentin and motrin for ear infections and fevers. Check your facts hun, they all have liver failures listed in their PI's they all have deaths related to liver failures listed in their PIs. The odds of having liver failure while on Ketek is actually less than that of augementin. Kids are the one group that NEED a new antibiotic, they have very little to choose from.
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