U.S., U.K. warn of suicide risk among youth taking paroxetine hydrochloride.

The U.S. Food and Drug Administration (FDA) is recommending that the anti-depressant medication paroxetine hydrochloride (marketed in the United States under the name Paxil) not be used to treat major depressive disorder in children and adolescents, though the agency warned that patients taking the drug not suddenly discontinue using it except under the advice of a physician.

The FDA's announcement on June 19 followed a similar recommendation nine days earlier by the Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K. Department of Health. The MHRA said that new data showed a rise in the incidence of self-harm and potentially suicidal behavior among children and teenagers under 18 taking paroxetine (licensed in the U.K. under the name Seroxat) for depressive illness. "It has become clear that the benefits of Seroxat in children, for the treatment of depressive illness, do not outweigh these risks," an MHRA news release stated.

According to the FDA, no evidence exists that Paxil is effective in children or adolescents with major depressive disorder (MDD), and Paxil is not currently approved in the United States for use in children and adolescents. Three well-controlled trials in pediatric patients with MDD failed to show that the drug was more effective than a placebo.

Paxil is approved for use in adults for the treatment of obsessive compulsive disorder, major depressive 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.

For more information about these advisories, visit the FDA Web site at www.fda.gov or the MHRA Web site at www.mhra.gov.uk.