Healthy Skepticism Library item: 10840

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Publication type: news

Silverman E.
FDA Won’t ‘Rule Out’ Repealing Black Box Warning On Antidepressants
Pharmalot 2007 Jul 7
http://www.pharmalot.com/2007/07/fda-wont-rule-out-repealing-black-box-warning-on-antidepressants/

Full text:

That’s what Tom Laughren, the FDA official who oversees psychiatric drugs, says may happen if CDC data on suicides in 2005, which will be released at year’s end, is compelling. The potential flip-flop comes amid growing noise by some psychiatrists that the agency’s Black Box warnings in 2004 that antidepressants are somehow linked to suicide in youngsters may be scaring some docs, parents and teenagers.

As evidence, some psychiatrists cite a recent study in The Journal of American Psychiatry, which found the number of scrips for pediatric depression, ages 5 to 18, fell more than 50 percent between 2003 and 2005. At the same time, the number of teen suicides jumped a record 18 percent between 2003 and 2004, the most recent year for which data exist.

“If I had known how much the label would rattle parents, I wouldn’t have voted for it,” Gail Griffith, who was the patient representative on the FDA panel that recommended the warnings, tells Newsweek.

For his part, Laughren notes that the study reflected “only one year of data,” but updated CDC may be revealing. “If the rates are up again, it’s likely we’ll go back to the board of advisers,” he tells the weekly mag, which notes the FDA has repealed only one Black Box warning in its history, on the acid-reflux medication Prilosec, which was withdrawn in 2003. “But I wouldn’t rule it out,” he adds. “The evidence is very compelling.”