It's a difficult issue to sort out because depression itself can lead to suicide, and studies clearly show that antidepressants have helped many people recover from depression.
Still, until the question is settled, FDA's own scientific advisers had urged stronger warnings that certain antidepressants may cause agitation, anxiety and hostility in a subset of patients who may be unusually prone to rare side effects.
Monday, FDA followed that recommendation, stressing that the most vulnerable time is when a patient starts therapy or changes the dose.
"We think this is good advice whether the drugs increase the risk or not," said FDA medical policy chief Dr. Robert Temple. "There's a reason people are put on therapy their depression is worse or somebody's worried about it. Maybe that's what drives it (reports of suicides) or maybe it's the drugs. In either case, you really need to pay attention in the early days."
While FDA's investigation into the possible suicide link initially focused on children and teenagers, Monday's warning includes adults, too. The FDA had investigated reports of suicide among adult antidepressant users in the early 1990s and concluded there was no link but on Monday revealed that it is reanalyzing that question.
The drugs of concern are newer generation antidepressants: Prozac, Paxil, Zoloft, Effexor, Celexa, Lexapro, Luvox, which are called SSRIs or SSRI-like drugs, and Remeron, Serzone and Wellbutrin, which operate differently.
Manufacturers didn't immediately say if they'd comply.