June 11, 2003 — British officials are warning doctors against prescribing the antidepressant Paxil for depression in children and teens. But U.S. officials at the FDA say they have not yet decided whether to issue a similar warning.

An advisory issued Tuesday by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) states that Paxil — sold under the brand name Seroxat in Britain — is associated with an increased risk of self-harm and suicidal behavior and thoughts in people under the age of 18.

“It has become clear that the benefits of [Paxil] in children for the treatment of depressive illness do not outweigh these risks,” the MHRA statement reads. The warning does not apply to the use of Paxil in adults.

Suicidal Thoughts, Attempts Double

The decision was made after Paxil manufacturer GlaxoSmithKline submitted data involving more than 1,000 pediatric patients taking Paxil for depression. Investigators found that suicidal thoughts and attempts were roughly twice as high among children and adolescents taking Paxil than among those taking placebos (3.2% vs. 1.5%).

Although Paxil is not specifically approved by the FDA for use in children, it is commonly prescribed for this age group in the U.K. and the U.S. U.K. Department of Health spokeswoman Alison Langley tells WebMD that roughly 8,000 of the close to 4 million prescriptions for Paxil issued in the U.K. last year were for children under the age of 18.

In a statement issued Tuesday, GlaxoSmithKline officials noted that no actual suicides occurred among the children taking part in the studies and that the British warning is for depression and not other psychiatric conditions. The FDA is considering a petition from the company to approve the drug for the treatment of obsessive-compulsive disorder in children.

GlaxoSmithKline is a WebMD sponsor.

The Other Side of the Story

GlaxoSmithKline spokesman Michael Fleming tells WebMD that the company does not feel the move by the British regulatory agency was warranted by the data and that the company is working with the FDA and other agencies to determine how to best interpret it. He pointed out that the overall rate of suicidal thoughts and attempts by children and teens with major depression is actually higher than the 3.2% seen in the study patients on Paxil.

“We do believe that the move by the MHRA will limit the choices that are available to doctors treating children and teenagers,” Fleming says.

FDA spokeswoman Susan Cruzan tells WebMD that the agency is considering the studies submitted by the drug’s manufacturer and will decide soon whether to take action.

Antidepressants for Kids

Child psychiatrist and researcher Neil Ryan, MD, says the available data indicate that Paxil and similar antidepressants — called selective serotonin reuptake inhibitors (SSRIs) — work better for childhood and adolescent depression than older antidepressants. The FDA approved the SSRI Prozac for use in children last January, but Ryan says that doesn’t necessarily mean that it is safer than Paxil.

“These drugs are different, but they aren’t that different,” he says. “It would be very surprising to me if one of these drugs produced these side effects while the other ones didn’t. But it is impossible to dismiss something like this. We just have to evaluate it as the data come out. That is not a great position to be in, but it is all that I can really say.”