FDA Issues New Warnings on Antidepressants

Additional "black box" labeling on depression drugs warns of suicide risk.

ByABC News
May 4, 2007, 11:07 AM

May 4, 2007 — -- As the Food and Drug Administration moved this week to expand warnings on antidepressants, it has once again inflamed the debate over this emotional issue.

In 2004 the FDA first warned that antidepressant use increased suicidal thoughts and behaviors among teens and adolescents in the first few weeks and months of use. The agency added the strongest warning, a black box warning, to the popular medications.

Now the FDA wants that warning extended to ages 18 to 24 as well.

But some psychiatrists worry this new warning will continue to steer people away from medications they desperately need.

The FDA first sounded the alarm over antidepressants in 2004. That year, according to the Centers for Disease Control and Prevention, teen suicides jumped 18 percent, the first increase in more than a decade.

Some believe that may be attributed to decreased use of the prescription medications. MedCo Health Solutions found a 13 percent decline in use of antidepressants by those 19 and younger in 2005, compared to 2004. And IMS Health also found a slight dip, 3 percent, in overall antidepressant prescriptions in 2005.

Chicago attorney Hanna Stotland, who began using antidepressants as a teenager, worries that the government warnings go too far. "I'm concerned anything that the government does to increase people's fear of these medications might discourage some people from seeking treatment that could save their lives," she told ABC News.

Many psychiatrists agree, and insist that antidepressants clearly work for many suicidal teens and young adults.

"When you look at the whole evidence puzzle in general," said Dr. Kelly Posner of Columbia University, "all the pieces pretty much point in the same direction, that antidepressants save lives, that untreated depression is what kills people."

Just last month a study in the Journal of the American Medical Association analyzed data from 27 studies and concluded that for children and teens "the benefits of antidepressants appear to be much greater than risks" The analysis also found that fewer than one out of 100 had an increased risk of suicidal thoughts.