WASHINGTON - Federal drug regulators failed to act aggressively when they learned in 1996 that children taking the antidepressant Zoloft exhibited increased suicidal behavior, according to evidence presented at a congressional hearing yesterday.
During a hearing of the House oversight and investigations subcommittee, lawmakers accused the Food and Drug Administration of knowing about the risks of the drugs years earlier than it has acknowledged. The FDA did not begin to examine the issue until 2002.
"There's something terribly rotten at the FDA," said Rep. Peter Deutsch, a Democrat of Florida. "No agency charged with protecting the public health should have behaved with such indifference to the public safety as is evidenced in this case."
The FDA disagreed that it ignored the issue for six years, saying that the 1996 Zoloft study, and a 1997 study of the drug Luvox that showed increased agitation in children, were not scientifically significant.
The risk of suicidal behavior for children taking Zoloft in a 1996 clinical trial was five times that of adults on the same drug, according to an FDA review. That caused enough concern that Dr. James Knudsen of the FDA wrote to Zoloft maker Pfizer Inc. asking for an explanation.
But a few months later the FDA discounted the study.