Young Adult Antidepressant Risk Higher

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Young Adult Antidepressant Risk Higher - FDA Staff

(December 6, 2006) - Antidepressants appear to raise the risk of suicidal thoughts and behavior in adults younger than 25, U.S. Food and Drug Administration staff said in an analysis released on Tuesday ahead of an advisory panel meeting set for next week.

Antidepressants already include strong warnings that they may trigger suicidal thoughts and attempts in some children and teenagers, but the Food and Drug Administration has been studying whether adults are also at risk and if similar cautions are needed for older patients.

"When results are analyzed by age, it becomes clear that there is an elevated risk for (suicidal thoughts or behavior) among adults younger than 25 years of age that approaches that seen in the pediatric population," an FDA staff summary said.

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Some doctors said the switch at age 25 was an interesting development that could help determine an age-limit for use of the medications, adding the overall results were consistent with earlier findings about suicide risk.

The FDA staff said antidepressants may protect adults between 25 and 64 years old from suicidal action. They also appear to reduce suicidal thoughts and behavior in those 65 and older.

The agency will present its review of 372 trials that compared antidepressants to placebos and involved nearly 100,000 patients to an advisory panel of doctors and scientists at a public meeting due to be held Dec. 13.

Agency reviewers said the results were generally consistent among various antidepressants but found an "intriguing" lower risk of suicidal thoughts or acts with Pfizer Inc.'s Zoloft though it was unclear why that particular drug stood out, according to the documents.

A Pfizer spokeswoman said the company was reviewing the FDA analysis, adding Zoloft data had already been made public. Other makers did not return calls or had no comment.

Dr. David Fassler, a psychiatrist at the University of Vermont College of Medicine, said the possibility of an increase in suicidal tendencies among young adults deserved further study. "However, the incidence of such events was also well below what one would generally expect in depressed patients," he added.

Still, Dr. Kelly Posner, a Columbia University researcher who worked with the FDA to analyze the data, cautioned against drawing a link between the drugs and younger patients. A number of factors, including the medicines allowing patients to discuss their suicidal tendencies, could be at play.

FDA reviewers said there was also "a slight suggestion" that drugs in the serotonin-norepinephrine reuptake inhibitor (SNRI) class may have a "greater effect" in those younger than 25 compared to selective serotonin reuptake inhibitors (SSRIs). It was unclear if the reviewers meant the suicidal risk was higher in either class.

SSRIs are some of the most widely used medications for depression and include Forest Laboratories Inc Lexapro, GlaxoSmithKline Plc's Paxil, Eli Lilly and Co.'s Prozac and Pfizer's Zoloft. SNRIs include Wyeth's Effexor and Lilly's Cymbalta.

Glaxo said in June it added findings to the Paxil label from a study showing young adults who took the drug in clinical trials were more likely to report suicidal behavior than others who got a placebo. The company said at the time it was hard to tell if the drug caused the behavior.

Complicating matters is that suicidal thoughts or behaviors can be symptoms of depression itself -- an illness that can leave patients feeling anxious, sad, and hopeless, with less interest in activities and decreased appetite.

About 9.5 percent of American adults experience some kind of mood disorder, including depression, each year, according the National Institute of Mental Health.

The FDA first began addressing suicide risk with antidepressants in 2003 after it received reports of children and teenagers who thought about or attempted suicide.

It ordered new warnings for youth on the drugs in 2004 and said it would also study the risk in adults.

The FDA said it would ask the advisory panel to discuss the analysis and agency plans to modify antidepressant labels. The panelists will not vote on specific questions, and the FDA will make the final decision, the agency said.

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The FDA documents did not say what label changes are being considered. FDA spokeswoman Susan Cruzan said the agency would discuss options at the panel meeting.

The FDA staff summary is posted on the agency's Web site.

By Susan Heavey
Source: HealthDay Reporter

Reuters

Last updated: 12/06

Young Adult Antidepressant Risk Higher - FDA Staff

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