FDA pushed 'voluntary' cold-meds change

You know last week's voluntary warning 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
- check out the story from the Associated Press

Suggested Articles

Former Retrophin CEO was hoping for a SCOTUS hail mary to escape his seven-year fraud sentences Turns out the court was interest in hearing his plea.

A new investigation shines light on how Purdue pushed back on negative coverage of opioids, placed opioid-friendly experts in think tanks and more.

After Merck and Bayer's vericiguat scored in a heart failure trial, you'd expect potential rivals to brace themselves. Not so for Novartis'…