FDA Issues Safety Advisory Recommending Against Use Of Selective Serotonin Re-Uptake Inhibitor (SSRI) Antidepressant Paroxetine (PAXIL) In Children

On June 19, 2003, the Food and Drug Administration (FDA) issued a public advisory concerning the safety of paroxetine (PAXIL), a member of the selective serotonin re-uptake inhibitor (SSRI) family of antidepressants, in children or adolescents less than 18 years of age. The advisory is based on reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents under the age of 18 taking paroxetine for major depressive disorder (MDD).

The FDA’s advisory followed a similar announcement nine days earlier, June 10, 2003, by the Committee on Safety of Medicines (CSM), the British counterpart to the FDA. New data from clinical trials in children and adolescents were received by the British regulators at the end of May 2003 and were reviewed by an Expert Working Group on SSRIs and the CSM. The British announcement said:

These data do not demonstrate efficacy in depressive illness in this age group and show an increase in the risk of harmful outcomes including episodes of self-harm and potentially suicidal behaviour in the Seroxat [British brand name for paroxetine] group compared to placebo. Various analyses suggest that the risk of these outcomes is between 1.5 and 3.2 times greater with Seroxat compared to placebo. On the basis of these data, CSM has advised that the balance of risks and benefits of Seroxat is unfavourable when used to treat depressive illness in this age group. CSM has advised that Seroxat should not be used in children and adolescents under the age of 18 years to treat depressive illness. The efficacy and safety of Seroxat for children in other indications have not been established.

Paroxetine is sold by GlaxoSmithKline of Research Triangle Park, NC in the U.S.

In this country, paroxetine has not been approved by the FDA for major depression or use in children under the age of 18 for any condition. The drug’s use in children under the age of 18 is known as an “off-label” use. Physicians can legally prescribe drugs for off-label uses even in the absence of substantial scientific evidence that the drug is safe and effective for an off-label use. The off-label use of drugs has accounted for a number of preventable drug tragedies in the U.S. and other countries.

A withdrawal reaction has been reported with all SSRI antidepressants. The symptoms generally start within one to three days after stopping the drug, and generally resolve within one to two weeks after the drug has been discontinued. Withdrawal symptoms may occur even when the dosage of the drug is gradually decreased. The main symptoms of this reaction are: dizziness, vertigo, uncoordination, nausea and vomiting, and flu-like symptoms that include fatigue, lethargy, muscle pain and chills.

This reaction appears to be more common with paroxetine.

What You Can Do

Parents of children taking paroxetine for major depression should consult the prescribing physician immediately.

DO NOT stop paroxetine treatment immediately. Discontinuation of this drug requires medical supervision.