Depressed over Prozac

The FDA, in its Health Advisory issued in March, asked drug companies to add stronger warnings to their package inserts, cautioning physicians and families to "closely monitor" both adults and children for suicidal thinking, and "certain behaviors that are known to be associated with these drugs," including mania and hostility, especially at the beginning of treatment, or when the doses are increased or decreased. The FDA stopped short of requiring the companies to issue these warnings, though, and made it clear that the matter of cause and effect has not been settled yet.

The FDA appointed a panel of independent experts to review clinical trials of antidepressant use in children and teens, trying to determine if these studies report more suicide attempts in patients prescribed the drugs compared to those given a placebo pill. The review follows allegations that GlaxoSmithKline failed to report trials that showed an increase in suicide attempts, as well as those trials that showed that Paxil was no more effective than a placebo for younger patients. According to the Wall Street Journal, which obtained a draft of the panel's review last week, the clinical trials show children and teens on the drugs were indeed more likely to have thoughts that appeared to be suicidal.

Earlier this month, Health Canada, the Canadian version of the FDA, issued a warning that newborns may suffer withdrawal and other possible symptoms (seizures, constant crying, etc.) when pregnant women take SSRIs during the third trimester of their pregnancies.

In June, the National Association for the Mentally Ill (NAMI) Policy Research Institute issued a report urging that psychotropic drugs should be prescribed for children "only when the anticipated benefits outweigh the risks." Next month, a congressional committee will hold hearings about the safety of antidepressants and the FDA's alleged censoring last winter of a staff member who argued that the drugs are dangerous for young people.

"From those who have seen the internal company documents," says Tracy, "we know that there is no distinction in age groups with these suicidal reactions. These reactions are the same across the board, no matter the age."

Utah cases

Tracy argues that the perpetrators of some of Utah's famous violent crimes — Margaret Kastanis, who stabbed herself and her three children in 1991; Sergei Babarin, who shot five people at the LDS Family History Library in 1999; Lenny Gall, who killed his mother with an axe in 2001 — were violent because they were either on antidepressants or had gone off them too abruptly.

Lenny Gall's father, Len, contacted Tracy six months ago, before his son's sentencing hearing. Tracy then went through Lenny's medical records, Gall says, and found that "he had a very significant reaction to Paxil when he was 16" and was put on the antipsychotic drug Zyprexa "shortly before" the murder. "He's never had a shred of violence in him," Gall says.