America's drugs 'watchdog', the Food and Drug Administration (FDA), is finally waking up to a drug scandal that is involving children as young as two years of age.
These children are being prescribed powerful antidepressants that could be making them suicidal, and so the FDA has agreed to review the practice.
Today, it's been reckoned that 2 per cent of all youths in the USA are now prescribed an antidepressant. Prescriptions to children increased by 400 per cent between 1988 and 1994 alone, a study has found.
Researchers have discovered that children as young as two have been prescribed an antidepressant such as Prozac, although usage more usually begins at the age of six and then carries on until the age of 19.
Nobody knows for sure how many children have committed suicide, attempted suicide or had suicidal thoughts while on these drugs, and regulators the world over have always hidden behind the fact that these children may have been suicidal because of their depression.
The FDA has nonetheless conceded that the drugs are more likely than a placebo to cause suicidal thoughts. It based its conclusion on a review of 20 placebo-controlled trials, involving over 4100 children and adolescents who were prescribed one of eight antidepressants. The 'gang of eight' includes citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone,paroxetine, sertraline and venlazafine.
Worse, perhaps, the FDA concluded that the drugs were not even effective.
Of the drugs reviewed, only Prozac (fluoxetine) has been approved for pediatric use, and fluvoxamine is not even approved as an antidepressant in the USA.
Pfizer, the manufacturer of sertraline, marketed as Lustral in the UK and as Zoloft in the USA, has been quick to try and distance itself from the review.
In a study of 376 depressed children aged from 6 to 17 years, sertraline was 'effective and well-tolerated', the researchers concluded. A generous conclusion for a study that saw 17 of the children having to stop treatment because of a side-effect, and two who tried to commit suicide. It's perhaps worth pointing out that Pfizer kindly sponsored the research.
But even leaving all that aside, there is no doubt that the drugs should not be prescribed to children anyway. Aside from Prozac, none of the drugs has been licensed for pediatric use, and so the drugs regulators should be stopping the practice for that reason alone.
(Sources: Pediatrics, 2002; 109: 721-7; Journal of the American Medical Association, 2003; 290: 1033-41).