Lustral (sertraline), or Zoloft, as it’s sold in the US, is back in the news, but for all the wrong reasons. It is among the ‘gang of eight’ antidepressants named by the Food and Drug Administration, the US drugs regulator, likely to trigger suicide or suicidal thoughts when given to young children and adolescents.
The FDA has studied 20 placebo-controlled trials, involving over 4100 young people, and has concluded that each of the drugs is more likely than a placebo to cause suicidal thoughts.
Its manufacturer, Pfizer, has been quick to distance itself from the other seven, including Prozac. In a study of 376 depressed children aged 6-17, sertraline was ‘effective and well-tolerated’ – a generous conclusion for a study that saw 17 of the children stopping treatment because of a side-effect, and two who tried to commit suicide. It’s also worth pointing out that the study was paid for by . . . Pfizer (JAMA, 2003; 290: 1033-41).
But neither the FDA nor the research team seems to be asking the more basic question: Why are children of six being given an antidepressant not approved for use in this age group?
The British National Formulary (BMA, 2003) is clear on its use, as is the FDA. Sertraline should not be given to children with depression, although it can be prescribed to children of six who suffer obsessive-compulsive disorder.
The unlicensed use of sertraline for depression is just one example of a growing trend to give antidepressants to young children. One study found that its use among children had increased by 400 per cent between 1988 and 1994, and that 2 per cent of all youths in the US were taking an antidepressant (Pediatrics, 2002; 109: 721-7).