British drug regulators warned Wednesday that common antidepressants other than Prozac should not be prescribed to children because of a risk that the drugs could make young patients suicidal.
A study of evidence from drug companies concluded that the risks from selective serotonin reuptake inhibitors, or SSRIs, to those under 18 outweighed the benefits, according to the Medicines and Healthcare Products Regulatory Agency.
Of the type of drug examined, only fluoxetine, marketed as Prozac, was not included in the warning, the agency said.
The regulatory agency said side effects included suicidal feelings, anxiety, insomnia, weight loss and headaches.
These drugs are not licensed for use by people under 18 years old, but an independent advisory group said some doctors independently prescribe them to youths, based on their own judgment.
In October, the U.S. Food and Drug Administration issued a 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 disorders in children.
Alasdair Breckenridge, chairman of the British agency, warned that patients on antidepressants should not suddenly stop taking them, but should talk to their doctor about treatment.
The drugs specified in the government announcement were sertraline, citalopram, escitalopram and fluvoxamine. Earlier this year warnings also were given about the risks of paroxetine and venflaxine. The regulatory agency said that leaves only Prozac, which appeared to have “a positive balance of risks and benefits” in treating under-18s.
Professor Gordon Duff, chairman of the independent advisory Committee on Safety of Medicines, said comprehensive advice was issued on the use of these drugs in children after a thorough review of all the evidence available.
The regulatory agency said it was going to release data from the clinical trials on antidepressants and children that had been supplied by the drug companies to allow doctors to assess the information on which the advice was based.