FDA plans to expand antidepressant warning
A Food and Drug Administration federal panel Wednesday recommended the agency issue its strongest possible warning to alert patients and doctors that antidepressants can increase the risk of suicidal thoughts and behavior in young adults.
The panel called for placing the so-called black-box warning on product labels and in medication guides distributed to patients.
Following the vote, FDA officials said they intended to expand the warning to include young adults.
Since 2004, antidepressants have had a black-box warning about an increased risk of suicidal thoughts and behavior in children and adolescents.
The recommendation to extend that warning to patients in their late teens and 20s came after the FDA’s review of 372 clinical trials. The review found the risks were related to age and the dangers seemed to disappear at age 25.
Still, some panel members said that 25 seemed like an arbitrary cutoff and that the risks for a 25-year-old were probably not much different from those for a 24-year-old.
“I am concerned that there is a false sense of security to some of these age brackets,” said panel member Dr. Marcia J. Slattery, a University of Wisconsin psychiatrist.
She said all patients taking antidepressants should be monitored for signs of suicidal thoughts and behavior.
In the end, the panel decided to leave the age limit of the warning for the FDA to decide. Patients younger than 25 account for about 8% of all antidepressant prescriptions.
The panel’s 6-2 vote came amid concerns the black box might discourage young adults who need help from using the drugs, which many doctors said were among the most effective treatments for depression.
Several panelists called for balancing the warning with a statement underscoring the necessity of treating depression.
“We are dealing with a very vulnerable population,” said panel member Gail W. Griffith, a patient representative from Washington.
The FDA’s review, which looked at 100,000 patients, found a small but significant risk of suicidal thoughts and behavior among 18- to 24-year-olds who took antidepressants. The agency said that four of 1,000 patients were at increased risk.
The FDA study found no increased risk for patients ages 25 to 30. The drugs seemed to protect against suicidal thoughts and behaviors after age 30 and particularly after age 65, the agency said.
The FDA had no explanation for the apparent age-related effects of antidepressant drugs.
Half of the patients studied took the drugs for depression, while the rest were testing the medicines for psychological disorders, such as anxiety, or behavior modification, including smoking cessation and obesity.
Across all the studies, eight people committed suicide, 134 attempted suicide and 528 thought about killing themselves or prepared to do so. The FDA said suicides were too infrequent to draw any association to the drugs.
The research focused on 11 commonly used antidepressants: selective serotonin reuptake inhibitors Celexa, Lexapro, Luvox, Paxil, Prozac and Zoloft; serotonin-norepinephrine reuptake inhibitors Cymbalta and Effexor; other antidepressants Remeron, Serzone and Wellbutrin.
The panel’s decision applies to all antidepressants, including an older class known as tricyclics.
About 19 million people in the U.S. have depression and 16 million are treated with antidepressants, according to Mental Health American, an advocacy group.
The vote came after an emotional hearing in which family members pleaded for strong warnings on drugs that they believed had caused loved ones’ suicides.
“We deserve to be told all the side effects,” said Kim Witczak of Minneapolis, whose husband, Woody, 37, hanged himself in 2003 after being prescribed Zoloft for insomnia.
But members of medical associations argued against the black box, saying it could indirectly lead to an increase in suicides because doctors might be afraid to prescribe the drugs for people who need them.
Dr. Carolyn Robinowitz, president of the American Psychiatric Assn., said suicides among 10- to 14-year-olds rose 16% to 244 in 2004 as antidepressant prescribing fell in advance of the FDA warning about suicidal thoughts and behaviors in adolescents.
“The black box has had unintended consequences,” she said. “Depression can be lethal.”
Last year, prescriptions for antidepressants fell 13% among children and adolescents and 8% among adults under 25, according to the prescription-tracking firm Verispan.
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