- The Washington Times - Sunday, February 8, 2004

Last week’s hearings examining whether popularly prescribed antidepressants increase the risk of suicide among American teenagers came years after concerns first surfaced about adequate testing.

Dr. Thomas Laughren, the Food and Drug Administration’s team leader for psychiatric-drug products, told The Washington Times in September 1998 that only a “handful of studies” had looked at the effects of Prozac and other antidepressants on hundreds of thousands of minors.

Prescribing doctors, Dr. Laughren said at the time, essentially were guessing about proper doses for the nonadult population.

The FDA demanded more pediatric and adolescent testing. Drug companies, initially unwilling, complied after Congress passed legislation awarding the companies an additional six months of patent exclusivity on drugs if they tested children and defined appropriate dosages for younger people.

By the end of the decade, no medications were approved for use by children with depression. Today, only Prozac officially is approved, although other medications approved for adults routinely are dispensed to the young.

The number of Americans 17 and younger who were prescribed one of the three top-selling antidepressants — Prozac, Paxil or Zoloft — climbed from 669,000 to 792,000 between 1996 and 1997, according to IMS Health, a pharmaceutical research firm in Plymouth, Pa.

The three drugs are part of a new generation of mood-altering medications known as SSRIs, or serotonin selective reuptake inhibitors, whose use in children is being reviewed by the FDA.

In a telephone interview Tuesday, Dr. David G. Fassler, a child and adolescent psychiatrist in Burlington, Vt., said data presented at the FDA hearings last week “suggest at least a million [American] children under 18 are taking SSRI medications.”

Many should be doing so as part of a “comprehensive treatment plan,” Dr. Fassler said, “given that 3 [percent] to 5 percent of all children and adolescents struggle with depression.”

“The medications are extremely helpful for some children,” Dr. Fassler said, noting that some parents testified Monday that they believed the medications “saved their children’s lives.”

But other parents testified that their teens killed themselves soon after starting treatment with an SSRI.

Asked about concern over a link between the drugs and teen suicides, Dr. Fassler said, “There have been discussions about suicide and antidepressants going back 10 or more years in adults.”

But after hearings on the issue in 1991, the FDA concluded there was “no association” between the drugs and adult suicide, he said.

An FDA advisory panel determined that patients who committed suicide while on Prozac probably had not been treated aggressively enough.

FDA regulators who testified last Monday said, for the first time, that clinical trials of antidepressants such as Prozac and Zoloft show a greater risk of suicide among children taking the drugs than among those taking placebos.

To date, 25 studies of the suspect medications involving 4,000 young people found 109 incidents of suicide attempts or suicidal thoughts, Dr. Laughren said.

The FDA’s disclosure was a surprise to some, as it is at odds with longstanding claims of U.S. psychiatrists that SSRIs are highly safe in children.

An FDA advisory committee deferred action, first asking Columbia University to do a second review, which should be completed by summer.

The scientific advisory panel urged the FDA to issue stronger warnings about the possible risks of SSRIs to children and adolescents.

One authority who is not impressed with the suicide data is Dr. Graham Emslie, a psychiatry professor at the University of Texas Southwest Medical Center in Dallas who conducted early studies that found Prozac and Paxil effective in depressed teens and children.

“It’s not convincing yet. There were no deaths in any of the clinical trials,” Dr. Emslie said in a telephone interview.

His “big concern,” he said, is that the FDA might outlaw the use of SSRI antidepressants in minors.

“The balance is getting lost here,” Dr. Emslie said.

Teens with “severe suicide risks are excluded” from clinical trials, he noted.

Postmortem studies also found that the “majority of kids who killed themselves had no blood levels of medicine in them,” the Dallas professor added.

What’s more, Dr. Emslie said, British authorities say SSRIs have only a 2 percent to 3 percent efficacy in minors.

In contrast, he said, his and other American studies found that 60 percent of youths on those drugs improved. That compared with a 40 percent improvement rate in those on placebos, he said.

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