America's most-prescribed antidepressant may kick off suicidal thoughts and self-harm in young people, says the drug manufacturer. A recent study by GlaxoSmithKline, the British drug company that produces Paxil, has led British officials to recommend that doctors refrain from prescribing it to children under 18.
The U.S. Food and Drug Administration followed suit. Reporting that it has not completed its evaluation of the new safety data, the agency emphasized that patients should not suddenly discontinue use of the drug.
In the Glaxo study, Paxil (Seroxat in the U.K.) more than doubled emotional side effects including mood swings, crying episodes, suicidal thoughts and self-harm in children, compared to those taking a placebo. It was the first study to document such side effects of the drug, one of the commonly prescribed antidepressants called SSRIs (selective serotonin reuptake inhibitors).
The reaction of the American psychiatric community has been conspicuously muted. Richard Kadison, M.D., director of health services at Harvard University, says that Paxil does lead to a higher incidence of weight gain and withdrawal symptoms when compared to other SSRIs. But he has not observed a significant increase in suicidal thoughts or behaviors.
"We've probably all seen one incident of increased depression with any of the SSRIs," says Kadison, "but I don't see any reason to pick Paxil out." He and his colleagues do not use Paxil as a "first-line" drug because of withdrawal problems and weight gain, a side effect that is particularly objectionable to young adults.
Columbia University psychiatrist John Mann, M.D., an expert on suicide, calls "premature" the warning against prescribing Paxil to children. Glaxo's data are insufficient for establishing a direct relationship between Paxil and instances of emotional side effects, he contends.
The warning may backfire. "Physicians may be afraid to use medications that are potentially helpful and important in prevention of suicide," says Mann. "If that is the case, there may actually be more suicides rather than fewer."
Mann points to a decline in suicides in the US as use of SSRIs has increased four-fold, suggesting the drugs may aid suicide prevention.
Following the warning, Glaxo spokesmen were quick to note that none of the children studied succeeded in committing suicide while taking Paxil.
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