London — Most varieties of the common class of antidepressants are not suitable for children because they could do more harm than good, Britain's drug regulator says.
The Medicines and Healthcare Products Regulatory Agency has reviewed scientific studies and concluded that there is no solid evidence that the benefits outweigh the possible side effects for patients younger than 18.
The drugs, known as selective serotonin reuptake inhibitors (SSRIs) have never been licensed for use in children in Britain. Nearly all the research on the pills was done on adults.
Although the drugs are not licensed for children, it is known that some doctors prescribe them anyway, said Gordon Duff, chairman of the independent advisory Committee on Safety of Medicines.
“This gives parents, young people and those who treat these devastating illnesses the information they need to make informed decisions about treatment,” Mr. Duff said of the new advice.
The panel said that only Prozac (fluoxetine) has enough research on children behind it to indicate that the benefits outweigh the side effects, which can include suicidal feelings, anxiety, insomnia, weight loss and headaches.
The Department of Health estimates that 30,000 to 40,000 children and teenagers are prescribed SSRIs in the United Kingdom and that about half of them are treated with Prozac.
The advisory panel was set up in May to look into the effects on children of paroxetine — marketed in Europe as Seroxat and in North America as Paxil — and other SSRIs.
The group announced in June its concerns over Seroxat. The latest advice completes the panel's assessment of all the SSRIs and expands the list of those unsuitable for children to include sertraline (marketed in Britain as Lustral and in North America as Zoloft), citalopram (Cipramil or Celexa), escitalopram (Cipralex or Lexapro) and fluvoxamine (Favarin or Luvox).
In October, the U.S. Food and Drug Administration issued a similar but more general health advisory alerting physicians to a possible link between antidepressant drugs and suicidal feelings in the young.
Only Prozac is approved in the United States for treatment of major depressive disorder in children.
Alasdair Breckenridge, chairman of the British agency, warned that patients on SSRIs should not suddenly stop taking them and should consult their doctors first.
The regulatory agency said it was going to release data from the clinical trials on SSRIs and children to allow doctors to assess the information on which the advice was based.
Professor Ian Weller, chairman of the working group, said there was no evidence to suggest the risks of treatment outweighed the benefits in adults.
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