FDA plans warnings on pills’ link to suicides

WASHINGTON -- A new Food and Drug Administration analysis backs earlier suggestions of a link between at least some antidepressants used by children and suicidal tendencies, prompting the agency to prepare new warnings.

Exactly what those warnings will say, and which drugs will be affected, hasn't been settled, according to FDA documents released yesterday. The agency will take the debate to its scientific advisers next month for help.

"While there remains a signal of risk . . . for some drugs in some trials, it is important to note that the data are not black-and-white in providing a clear and definitive answer," the FDA's psychiatric drugs chief, Dr. Thomas Laughren, wrote this week.

Last year, British health authorities declared that a list of popular antidepressants might sometimes increase the risk of suicidal behavior in children and teenagers, and declared all but one -- Prozac -- unsuitable for depressed youth.

In March, the FDA urged doctors to monitor closely patients of all ages for warning signs of suicide, especially when they first start the pills or change a dose. The reason: They may cause agitation, anxiety, and hostility in patients unusually prone to rare side effects. Or, in the time period when severe depression just starts to lift but isn't yet much better, patients who had been too lethargic to act on suicidal thoughts might gain the energy to do so.

Now the question is whether the drugs' labels need still more warnings -- or specific instructions not to prescribe certain ones to children and teenagers.

Among 25 studies involving 4,000 children and teens and eight antidepressants, there were no completed suicides.

The FDA analyzed those studies in February, sent them for a second opinion from Columbia University researchers, and then reanalyzed them together with the Columbia data.

The result: Lump all the studies together, and patients given any of the antidepressants were about 1.8 times more likely to have suicidal thoughts or behavior than patients given placebo pills, FDA reviewer Dr. Andrew Mosholder wrote his bosses on Monday.

However, most suicidal tendencies showed up in studies with the highest proportion of patients who had a history of suicidal behavior before they were enrolled, noted a separate review by the FDA's Dr. Tarek Hammad. Other studies didn't even admit those high-risk patients.

Further complicating the assessment, the risk varied widely not just from drug to drug but between studies of the same drugs, Hammad found.