FDA Warns Against Prescribing Paxil to Children

Dear Doctor Column, September 1, 2003

Question:

My child has been taking Paxil for depression for several months, but her doctor recently prescribed a different antidepressant, saying that new studies show that Paxil doesn't work in children. My child seemed to be doing better on the drug. What can you tell me about this?

Answer:

The United States Food and Drug Administration (FDA) released a statement on June 19, 2003, announcing it is reviewing reports of a possible increased risk of suicidal thinking and suicide attempts in children and adolescents under the age of 18 treated with the drug Paxil (paroxetine) for major depressive disorder (MDD).

The announcement was based on the results of three well-controlled clinical trials carried out in children (under 18 years of age) with MDD comparing the effect of Paxil and placebo (sugar pills). The studies found that Paxil did not work any better than placebo in the treatment of MDD. The pediatric studies also showed that certain, possibly suicide-related behaviors, including suicidal thoughts and attempts, were more common in children receiving Paxil. The risk of these events was about three times greater with Paxil compared with placebo. There were no deaths in these trials.

Following its review of the same data, the United Kingdom (UK) Department of Health issued a press release about 2 weeks prior to the announcement issued by the FDA stating that Paxil (brand name Seroxat in the UK) must not be used to treat children and teenagers under the age of 18 years for depressive illness, due to an increase in the rate of self harm and potentially suicidal behavior in this age group when the drug is prescribed for depression.

Although the FDA has not completed its evaluation of the new safety data, the agency is recommending that Paxil not be used in children and adolescents for the treatment of MDD.

Paxil is one of a class of medicines called selective serotonin reuptake inhibitors. These drugs increase the activity of an important brain chemical called serotonin, a chemical known to be deficient in patients with depression. In addition to MDD, the drug is approved for use in adults for the treatment of obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and post-traumatic stress disorder. There is no evidence that Paxil is associated with an increased risk of suicidal thinking in adults.

Paxil is not approved by the FDA for treatment of depression in children. However, doctors may prescribe the drug as an off-label prescription for pediatric patients.

Children and teenagers already taking Paxil should not suddenly stop the pills, the FDA stressed. Some doctors may feel the drug is helping enough to keep a particular patient on the drug, which the FDA warning does not forbid. Those who do stop taking Paxil need medical supervision to taper off and avoid rebound side effects.

Why would Paxil cause such a side effect in depressed children but not adults? The FDA said it is not clear, but noted that childhood depression itself is different from adult depression, probably because of changes the child's brain undergoes as it grows. A number of adult antidepressants have failed to work in children. Plus, children often suffer different side effects from a variety of medications than adults do.

There is one FDA-approved treatment for depression in children, the competing drug Prozac. On the Web, FDA Paxil info: www.fda.gov/cder/drug/infopage/paxil/paxilQ&A.htm