Panel Urges Child Antidepressants WarningSep 15, 2004 | AP
The warning, among the strongest in the Food and Drug Administration's arsenal, should reach doctors no matter how they get drug information and would extend to drug advertising directed at patients.
That's the majority opinion of federal advisers, who heard testimony Monday about antidepressants' powers and perils from doctors, researchers and relatives of patients who killed themselves after taking such medication. The panel spent the bulk of Tuesday deliberating before issuing its recommendation.
The black box option is more strident than the bold-letter warnings the same federal advisers suggested be added to antidepressant labels this March. Antidepressant prescription rates to children were unchanged by the earlier warning.
Unlike the earlier red flag, advisers said this new warning should make clear that antidepressants have been linked to two to three more children per 100 having heightened suicidal thoughts and behaviors.
The FDA will spend the next few weeks reviewing transcripts of the committee's comments before it decides which actions to take. The FDA isn't required to follow the recommendations of its advisory committees, but usually does so.
A suggestion that the agency create an antidepressant guide written in laymen's terms appears to be a slam dunk, since three dozen drugs already include them and the FDA advisory panel unanimously endorsed that concept.
The black box warning, endorsed by some families, garnered 15 supporters and eight dissenters among FDA advisers. Two voting members of the panel left the marathon meeting before Tuesday's crucial vote.
"When the decision is divided, it's less of a sure thing," Dr. Robert Temple, director of the FDA's Office of Drug Evaluation, told reporters later.
Wyeth Pharmaceuticals, which manufactures the antidepressant Effexor, will note that split decision when it discusses the best warning option with FDA officials, said Dr. Joseph Camarado, senior vice president of medical affairs.
A dozen psychiatrists who testified during the two-day hearing will probably weigh in with more details of antidepressants' benefits for children, said Dr. David Fassler, trustee at large for the American Psychiatric Association.
"It's important to note it was a split vote. I think that's consistent with the fact the data is not entirely consistent or clear," Fassler said. "I don't think the discussion is over."
On Monday, Fassler testified that 3 percent to 5 percent of children are depressed and that more than 500,000 depressed children attempt suicide each year.
Many FDA advisers said they were conflicted: Grieving families clearly wanted heightened warning labels. Yet, mental health professionals fretted about the chilling effect of black box warnings, a note that comes at the top of the drug's label, whether it arrives electronically or by paper.
Dr. Matthew Rudorfer, a mood disorder specialist at the National Institute of Mental Health, voted against the black box warning. The 2 percent to 3 percent increased risk of suicidal thoughts that alarmed the panel was overshadowed by the 15 percent risk of suicides by children with untreated depression. "I fear the black box would impede access to treatment," Rudorfer said.
FDA advisory committee chairman Dr. Wayne Goodman, psychiatry chairman at the University of Florida, acknowledged complications for prescribing physicians while still voting for the proposal. "I anticipate there will be alarm from parents and the child," Goodman said. "I think that's worth that complication, because it will raise the threshold" for prescribing the drugs to children.
The black-box warning should be joined by data showing which antidepressants work for depressed children, FDA advisers suggested. The recommendation, if endorsed by the drug agency, would mean that Prozac, shown in three studies to effectively treat depressed youth, would carry that notice. Paxil's shortcomings in treating 700 depressed children in clinical trials, meanwhile, could become more transparent.
The panel stopped short of asking for an outright ban on antidepressants for children.
A black-box warning would have made a "huge difference" in alerting patients to risks, said Kathleen Bodnar, whose 21-year-old daughter killed herself last March while taking Celexa. Liz Torlakson switched to Celexa from a liver-damaging competitor 16 months earlier, when "she demanded that her doctor give her something safe," Bodnar said.