FDA plans to expand Antidepressant Warning

Antidepressant drugs increase the risk of suicidal behavior in more patients than previously believed, thus broad safety warning on such medications is required, the US Food and Drug Administration advisory panel said Wednesday.

According to a federal advisory panel, which voted 6-2 to recommend the warnings after a daylong hearing, strong warning labels on antidepressants about suicide risk should be extended to include not only children and adolescents but also young adults.

In 2005, the FDA recommended 'black box' warnings be placed on all antidepressant medications indicating that they may result in increased risk of suicidal tendencies in children and adolescents only. The agency officials yesterday said they would now move to widen the warning to include adults up to 25 years old.

After reviewing 372 studies involving about 100,000 patients and 11 brands of drug used to treat depression including Prozac and Cymbalta from Eli Lilly, Paxil from GlaxoSmithKline and Effexor from Wyeth, the US health agency, which usually follows recommendations from its advisory panels, decided to expand the warning labels that until now applied only to children and adolescents.

When the US agency analyzed the results by age, it found clear-cut evidences of an elevated, though small and short-term, risk for suicidal thoughts and behavior among adults 18 to 24. "There's a clear pattern in the estimates with increasing age,” said Mark Levenson, an FDA scientific reviewer.

"We want to extend the age in the black box and at the same time not discourage treatment," said panel member Dr. Andrew Leon, a psychiatrist at Weill Medical College of Cornell University in New York.

The FDA said that the increased risk could mean the growth of 14 more cases of suicidal thoughts or behavior in every 1,000 children treated with antidepressants, while for adults 18 to 24, there could be four additional such cases per 1,000.

The federal government agency also recommended that patients of all ages should continue to be observed carefully for signs of suicidal tendencies when they are beginning treatment on these drugs.

Besides related drugs including Effexor and Wellbutrin, the agency’s latest move applies to selective serotonin reuptake inhibitors (SSRI's) such as Prozac and Paxil.

Meanwhile, psychiatrists are split on the recommendation of additional warnings. Some psychiatrists think that further warnings could lead to more suicides. They also think that additional warnings could curtail use of the drugs and eventually do more harm than good.

Dr. Carolyn Rabinowitz, president-elect of the American Psychiatric Association, said, "We're talking about a devastating, chronic and recurrent disorder, and a black-box warning may serve as another barrier to care that people need," Dr. Rabinowitz said.

According to mental health experts, updating the "black box" or other warnings on the medications could deter patients from seeking or beginning treatment.

But some psychiatrists think otherwise. In support of the expanding warnings, they say the labeling might make doctors be more careful about how they prescribe the drugs, keeping them in reserve for severely depressed patients.