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Editor: Robert Binstock
Profession: Paxil Side Effect Attorney

Category: Paxil Suicide

The Food and Drug Administration (FDA) has ordered drug makers to add warnings on antidepressant medications, stating the drugs can increase risk of suicidal behavior and thinking in young adults.

The labels, which include similar warnings for children since 2005, will now apply to people that are younger than 25.

The new expanded warnings that will appear in a black box, displayed blatantly on the prescribing information, are the strongest of cautions that regulators can enforce.

The FDA also recommends that the labels remind prescribing doctors to balance the risk against "clinical need" for treatments that include drugs such as Paxil and Zoloft and are associated with increased suicide risk in patients that are 25 and older and appear to reduce the risk in those 64 and older.

About 11 percent of adults younger than 44, or 12 million Americans, received at least one prescription for an antidepressant last year, say estimates by Medco, the largest prescription manager. Census figures suggest that 19- to 24-year-olds could make up about a fourth of that group.

It is highly unusual for warning labels to mention benefits like the lower risk of suicide in older adults, but the mixed message reflects the years-long debate over the risks and benefits of antidepressants, experts said. It also reflects concerns that the debate, and the headlines it has generated, have scared consumers and doctors away from medications that could help, the experts said.

The label changes follow recommendations from an advisory panel of outside experts that includes consumer representatives and psychiatrists that met in December. The panel heard scientists and people have lost loved ones to suicide after being prescribed an antidepressant.

The FDA reached this conclusion after studying 295 studies of antidepressants that included 77,000 adults from college students to retirees. Analysis found no increased risk of suicides in patients taking the medications.

But 21 suicide attempts were reported among the 3,810 19- to 24-year-olds taking the drugs, working out to a 0.55 percent risk, twice the risk in adults of the same age who took placebo pills, the analysis found.

By age 25, the risk was not significantly different, the agency said. The agency said it did not know why the risk would drop suddenly after age 25. But neuroscientists say there is some evidence that brain development continues into the early 20s.