The antidepressant drugs -- Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Effexor, Wellbutrin, Serzone and Remeron -- are taken by 30 million Americans, according to some estimates. The first seven are serotonin reuptake inhibitors, and their sales in 2003 exceeded those of any other drug class except the group of painkillers that includes codeine.
An estimated 7% of the Americans taking the medications are children. Drug use is tracked by the number of prescriptions written. A total of 2.7 million antidepressant prescriptions were dispensed for children younger than 12 and 8.1 million were written for adolescents in 2002, according to the FDA, although some individuals received more than one prescription a year.
In studying reports from 28 clinical trials, most of them unpublished and thus not open to public inspection, Mosholder concluded the data showed a "statistically significant" risk of serious suicidal events among children taking the drugs. And he stressed that what he acknowledged were limitations in the data he was analyzing would not change his conclusion.
"Finding a statistical association despite these limitations makes the finding difficult to dismiss," he wrote in one of the documents, which was authenticated by government officials familiar with the document. FDA officials would not comment directly on the documents.
Dr. Robert Temple, associate director for medical policy at the FDA's center for drug evaluation, said Mosholder "thought those data were persuasive just as they were." But his superiors believed that it was "premature" to come to the conclusion that the drugs were linked to suicide, he said.
Temple and other senior FDA officials think that some of the data from the drug companies were flawed because they were based on the firms' own decisions about what constituted serious suicide-related events.
For instance, there were several cases of teenagers who cut themselves but were not planning to kill themselves. Still, those cases were counted as serious suicide-related events by the drug companies; senior FDA officials decided they should not have been counted. The FDA is having suicide experts at Columbia University reexamine the data.
"We would be doing something bad if we made them look like they are more dangerous than they are, just as we would be doing something bad to make them look much less dangerous than they are," Temple said. "It's important to do this right."
