FDA Issues New Warnings on Antidepressants

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.

Despite that, the FDA defends the need for the black box warnings on these drugs. Dr. Robert Temple, director of the Office of Drug Evaluation for the Center for Drug Evaluation and Research, said, "I don't feel bad that we told people the truth about what the drugs do. I mean, that's our job."

Cathy Harter of Troy, Ohio, also believes the FDA is right in issuing its black box warnings. Harter's 19-year-old son Stephen committed suicide in September 2004, just days after he starting taking Paxil for anxiety.

Cathy said Stephen got the medication from his family doctor, who warned him it might cause nausea, diarrhea or sexual side effects. But Harter said the doctor did not even know the medication could lead to thoughts of suicide, and never warned her son about that.

It was just two weeks after Stephen was buried that the FDA announced its black box warnings for all antidepressants.

Harter insists that patients and their families should know about the risks of antidepressants or any drugs. "We have a right to know," Harter said. "Nobody has the right to withhold that information from us."

Harter said she is not against the use of antidepressants but believes people must be allowed to weigh both the benefits and the risks.

As for whether the new warnings will frighten away patients who might need the medication, Harter said, "They're using the defense that it's scaring people away, people are afraid of the drugs now, and actually I think people are more afraid of what they're not being told."

But the FDA does admit it is worried about the decline in use of antidepressants. It's why the agency also wants new language on the label to let patients know that depression itself is harmful. The warning would read, "Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions."

The FDA said the purpose of its black box warnings is not to discourage antidepressant use. The agency said it is trying to warn patients to use the drugs carefully, and with close monitoring by doctors, especially when medication is first started. That is the time of highest risk.

Dr. Andrew Leon, of Cornell University's Weill Medical College, sat on the advisory committee that recommended the new labels. He put it this way: "I don't want a primary care doctor to give them a blister pack [of the medication] and say come back in 30 days."

For the FDA's comprehensive list of the medications affected by the labeling change, click here.