Two to 3 percent of children treated with antidepressants had suicidal thoughts or behavior as a result of the drugs, officials said yesterday, based on the Food and Drug Administration’s most comprehensive analysis of past clinical trials of the widely used drugs.
In a sharp departure from a decade-old position, agency officials said the increase in suicidal tendencies was not a result of the children’s underlying depression but was caused by the medications themselves.
“Out of 100 patients treated, we may expect to see two to three patients (who) will experience increases in suicidality due to short-term treatment,” said Tarek Hammad, the FDA analyst who conducted the latest review. The increase, he said, “is beyond the suicidality as a result of the disease being treated.”
Senior FDA officials acknowledged that the results of the new analysis were substantially the same as the conclusions reached nearly seven months ago by an agency scientist who also found an increase in suicidal tendencies in children taking the medications.
At the time, the FDA declined to make the conclusions of staff scientist Andrew Mosholder public, citing a lack of confidence in his results.
Hammad spoke on the first day of a two-day hearing by an FDA advisory panel on the controversy over the reported risks of prescribing antidepressants to young people.
Robert Temple, the FDA’s associate director for medical policy, defended the decision not to present Mosholder’s conclusions in March. “Obviously people can disagree,” he said.
At a news briefing that included Mosholder and Hammad, Temple said the FDA realized that taking these drugs might increase suicidal tendencies.
“But depression alone is a cause of potential suicide,” he said, “so scaring people needlessly and overdoing it is worrisome also.”
Parents and other critics of the FDA had accused senior officials of having turned a blind eye to the worrisome data. But Temple, Hammad and Mosholder agreed that the studies lent themselves to differing interpretations, in part because they were not originally designed to answer questions about suicidal tendencies. While individual clinical trials sometimes contradicted each other, the FDA officials said a broad pattern of evidence had emerged that, on average, children taking the medications had about twice the risk of developing suicidal behavior or thoughts compared with children receiving a placebo.
“It’s very consistent,” Temple said, adding that regulators today would examine whether the drugs’ labeling should be modified and whether some drugs for children should be recommended to physicians ahead of others.
The controversy over the drugs is the subject of several congressional inquiries. Physicians and families have complained that pharmaceutical companies had kept secret the results of more than half the trials that found the drugs were no more effective than placebos.
Prozac is so far the only medicine approved by the FDA specifically to treat children’s depression, but physicians routinely prescribe other drugs of the same type, called selective serotonin reuptake inhibitors, to millions of American children.
Experts had previously said that studies of Prozac turned up no increase in suicidal tendencies, but its unique status came into question yesterday.
Hammad testified that a recent government-sponsored study, which researchers had described as convincing evidence of Prozac’s effectiveness, found it carried the same risk of triggering suicidal behavior as other drugs.
In March, the FDA officials issued an advisory to physicians reminding them to be vigilant to the possibility of suicide in children and adults taking the drugs.
The data presented yesterday suggested increased suicidal tendencies seen in the trials may be unique to children.