FDA pushed 'voluntary' cold-meds change

You know last week's voluntary warning [1] on cold meds for kids under four? Turns out that it wasn't so voluntary. According to the Associated Press, the FDA pushed drugmakers to warn against using the OTC drugs in young children. And the four-year-old cut-off appears to have been a compromise proposed by FDA in behind-the-scenes talks with the companies involved.

A panel of FDA advisers last year suggested that the threshold should be six years. And some of those advisers weren't happy with last week's move. "There was no data suggesting that the drugs were effective in kids under 12," one expert adviser told the AP. And, as the news service points out, ER data shows that the meds sicken about 7,000 kids a year, mostly because of overdoses.

As you know, pediatricians have been lobbying the FDA to ban the cold products for kids under six, and an agency advisory panel agreed. But the FDA itself made the under-four suggestion instead.

- see the Health Blog post [2]
- check out the story [3] from the Associated Press

Related Articles:
No more cold meds for kids under four [1]
FDA to revamp rules on kids' cold meds [4]
FDA experts mull ban on child cold meds [5]
Drugmakers recall infant cold meds [6]