New report slams antidepressants for children

Sharon Kirkey
CanWest News Service

OTTAWA -- The benefits of antidepressants prescribed to thousands of Canadian toddlers, children and teens have been exaggerated and the risks downplayed, according to a disturbing new report that's raising concerns about the drugs' potential for harm.

And the researchers who wrote it conclude there is no evidence to justify prescribing these drugs to children.

The Australian team reviewed six published studies of Prozac, Paxil and Zoloft _ drugs known as SSRIs, or selective serotonin reuptake inhibitors _ as well as Effexor.

According to the study, published in today's edition of the British Medical Journal:

- Children who took a placebo showed strong improvement and those who took the real drugs didn't do significantly better. Two small studies found no advantage for the antidepressants over the placebo.

- In one study, 11 of 93 adolescents taking Paxil had a serious adverse event, compared to two of 87 children taking a placebo. The Australian team says that, despite this striking difference, the study's authors concluded Paxil was ''generally well tolerated'' and that most side effects were not serious, even though seven of the youth on Paxil had to be admitted to hospital during treatment. Five were admitted with side effects that have been linked with SSRIs, including suicidal thinking. But ''only one serious event (headache) was judged by the treating investigator to be related to paroxeteine (Paxil) treatment.''

- Drug companies paid for the trials and ''otherwise remunerated'' the authors of at least three of the four bigger studies. Two of the authors of one study testing Paxil in teens were employees of GlaxoSmithKline, which makes the drug. In another study of the Pfizer drug Zoloft, Pfizer paid all the authors, and the study supervisor held stock options in Pfizer. Funding for another study of Prozac was originally attributed to the U.S. National Institute of Mental Health, but U.S. Food and Drug Administration records show Eli Lilly, manufacturer of Prozac, paid for the study.

- The authors of the four larger studies ''exaggerated the benefits, downplayed the harms, or both,'' raising serious concerns over whether the medical journals that published their work bothered to properly scrutinize their data.

- Overall, the numbers of children studied were small, the followup period short and the dropout rates high. The Australian team fears biased reporting and ''overconfident recommendations'' are misleading doctors, patients and their families and that many are overlooking non-drug treatments that are ''probably both safer and more effective.''

The study, led by researchers at the Women and Children's Hospital in North Adelaide, comes on the heels of a U.S. report showing that the number of children and adolescents taking Paxil and other antidepressants increased 49% between 1998 and 2002, with the biggest jump in preschoolers.

None of the drugs has been approved in Canada for anyone under 18, but doctors are prescribing them ''off-label'' -- which they are allowed to do -- to children as young as three for depression, anxiety, social phobia, attention problems and obsessive-compulsive disorder.

In a statement, Pfizer said that it plans to send a detailed response to the British Medical Journal, regarding ''inaccuracies and omissions'' in the report.

Health Canada issued a public advisory in January about the increased risk of suicide in children taking SSRIs. In February, an expert advisory panel asked Health Canada to require drug makers to add new warnings in materials provided to doctors.