'People Have a Right to Know'

Even before its black-box decision, the FDA earlier this year asked the makers of 10 leading antidepressants to include labels alerting both doctors and consumers to danger signs like agitation, anxiety or hostility in patients of all ages. But critics say such warnings can get lost in the fine print.

"Any severe risk should be spelled out," says Vera Hassner Sharav, president of the Alliance for Human Research Protection, a patients' rights organization. "People have a right to know. We're not going to scare people off with a warning. It's just to help them make a thoughtful decision--not an impetuous one based on advertising."

Kweder says the agency will not consider requiring the same black-box warnings for adults until it has re-evaluated the data for dozens of trials. That process is expected to take much longer than the examination of data for under-18s because there are more studies involving adults. "It could last easily a year, if not longer," she says. "It's a much, much bigger undertaking."

The FDA first investigated reports of suicide among adult antidepressant users when Prozac began to be widely used in the early 1990s. "I was hoping they would have done it [required the warning] then, but they weren't recognizing the problem," says Dr. Martin Teicher, director of the laboratory of developmental psychopharmacology at McLean Hospital in Belmont, Mass. In early 1990, Teicher authored a study published in the American Journal of Psychiatry describing the emergence of violent suicidal thoughts in six adults taking Prozac. Teicher's report spurred a series of stories--and lawsuits--questioning whether the popular antidepressant was to blame for some patient suicides. But the FDA concluded that there was not sufficient evidence of a link between the two.

Since then, however, practitioners have noted increased "suicidality" (defined as suicidal thoughts or behavior) in a small number of adult patients after starting an antidepressant or altering the dosage. ""They tamper with the brain's chemistry in ways we don't fully understand and may be at times dangerous," says Dr. Joseph Glenmullen, a Harvard psychiatrist. "While antidepressants work in a lot of people and help a lot of people, they are very harmful to others."

Glenmullen wrote the critical 2001 book "Prozac Backlash" (Simon & Schuster) after observing the side effects in some of his own patients in the mid-1990s. More recently, he's investigated the risks of starting antidepressants and altering dosages for his next book, "The Antidepressant Solution: The Only Step-by-Step Guide to Safely Overcoming Antidepressant Withdrawal, Dependence, and Addiction" (Free Press) due out early next year. While he agrees there are differences between the brains of children and adults, Glenmullen dismisses claims that the risks of suicidality are limited to children as "industry spin" based on "junk science." Teicher, who is now studying how depression affects the brains of patients between 18 and 22 years old, says tremendous changes in the brain do occur during childhood and early adolescence that may make younger patients more "sensitive" to the medication. Still, he says that adults are likely to face similar risks to children.