Paroxetine may increase suicide risk in children. (Safety Data Pending).

Paroxetine should not be used to treat depression in children or adolescents with major depressive disorder, according to the Food and Drug Administration.

Paroxetine (Paxil) has not been shown to be effective for the treatment of depression in the under-18 age group, and there might be an increased risk of suicidal ideation and/or suicide attempts with its use in this group, according to the FDA.

But the drug should not be discontinued suddenly because of the risk of withdrawal reactions, the FDA cautions.

"There is no evidence that paroxetine is associated with an increased risk of suicidal thinking in adults," the FDA said in a statement.

The new safety data are still under review, but in the matter of efficacy "three well-controlled trials in pediatric patients with major depressive disorder failed to show that the drug was more effective than placebo," the FDA concluded.

At the end of May GlaxoSmithKline, the manufacturer of Paxil, submitted nine dinical trials on paroxetine to regulatory agencies around the world, including the FDA and the Medicines and Healthcare Products Regulatory Agency its British equivalent. Three of the trials the company submitted were on the use of paroxetine for depression in 1-to 18-year-olds, said Dr. Philip Perera, medical director of CNS clinical development at GlaxoSmithKline,

On June 10 MHRA's Committee on Safety of Medicines released a statement on the paroxetine data: "These data do not demonstrate efficacy in depressive illness in this age group [1-18 years]," and the risk of harmful outcomes in those under age 18 who have depression is between 1.5 and 3.2 times greater with paroxetine than with placebo.

Three of the nine trials were on the use of paroxetine in obsessive-compulsive disorder and three on its use in social anxiety disorder. The FDA and MHRA have not issued warnings on the drug's use in children and adolescents with these conditions.

"One of the worrying things about this is that physicians have found themselves with few or no options to treat depressive illness in children," said Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline.