I learned about this tonight at work . . . from an angry Mom who could not find "Tylenol with Cold" drops at the drugstore because they had been pulled from the shelves. I got an earful.
Cough and cold medicines for children under 2 "voluntarily" re-called.
"This is not a situation in which pediatric data are lacking and we are unable to say one way or the other," Dr. Jay Berkelhamer, the (American) academy's (of Pediatrics) national president, wrote the FDA last month. In multiple studies, they have "been found not to be effective in this population at all."
The FDA is bringing its scientific advisers together Oct. 18 and 19 to debate the issue, but its own preliminary review concluded that very young children shouldn't take some of these commonly used medicines. And while the FDA's main focus is on children under 6, it also will ask whether there's evidence that these drugs work in children up to age 12.
FDA praised the drug makers' withdrawals Thursday as important for protecting babies.
O really?
With regards "to protecting babies" where has the FDA been FOR YEARS as Pediatricians were verbally pummelled by angry parents for not prescribing prescription variations of these drugs (so they could be paid for by insurance . . . particularly Medicaid)?
For that matter, where were the big guns at the Academy of Pediatics?
I can't speak for my distinguished colleagues, but I can tell you where the FDA was.
Protecting profits for drug manufacturers.
Even now, I predict that the FDA's decisions will be NOT about "protecting" anyone . . . but instead covering the asses of companies now faced with tremedous liabiliy if their products are ruled "unsafe".
Maybe parents will get it now. I'm way tired of giving the speech.
On the bright side, if SCHIP is passed, it might be a way that the program (for poor children) can save serious money.
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