The Food and Drug Administration required two weeks ago that all manufacturers of anti-depressant medications to start placing labels on products warning of the drugs' potential to induce suicidal thoughts in children and adolescents.
This decision came as a result of FDA clinical trials that showed a 2 percent increase in suicidal thoughts in children taking anti-depressants versus those on placebos. The warnings are mandated on all anti-depressants because of the inability of the FDA to distinguish their individual effects on children and adolescents.
The warning label, commonly referred to as a "black box," is the most serious of all warnings that can be placed on prescription drugs. Prior to this ruling, only 10 children's anti-depressant medications required a warning, according to the FDA.
The requirement stems from a test the FDA conducted 24 times on 4,400 patients with major depressive disorders, according to Tamara Rose, a consumer safety technician with the FDA's Baltimore district. Over a period of four months, nine anti-depressants were tested, including Prozac, Zoloft and Wellbutrin.
While these trials were focused on children, the FDA is recommending that all patients, regardless of age, be monitored for the first few months of treatment.
AU students who are taking anti-depressant medications should abide by their warnings and are encouraged to ask their doctors about concerns they might have, Counseling Center Director Abigail Lipson said.
"College age is a stage of life during which many students experience significant changes in their physical and emotional development," Lipson said. "For this reason, medications can work somewhat differently as a student matures and as their life situation changes."
The warning is designed to remind doctors to distribute the drug only when a medical condition makes it necessary. The American Psychiatric Association has urged the FDA to track and monitor potential negative changes in patients' behavior due to reduced access to medication, The Washington Post reported.
The severity of the warning has psychiatrists and drug manufacturers concerned that the warning will affect their sales. They believe clinically depressed persons who need the drugs may refuse them, due to the warning label.
The FDA defends the labels as necessary for public health and safety.
"Our conclusions are based on the latest and best science," acting FDA Commissioner Lester Crawford said, according to Rose. "They reflect what we heard from our advisory committee last month, as well as what many members of the public have told us."
The FDA suggests the warning labels include reference to the potential increased suicidal thoughts in children and adolescents with major depressive disorders, a list of drugs appropriate for children and adolescents, and recommended observation of patients who begin treatment. As of now, Prozac is the only medication the FDA has certified for use in children and adolescents.
Along with the warning labels, the FDA also plans to distribute a guide to patients with information about the effects of anti-depressants, Rose said.
Lipson said she hoped the new warning labels would increase the awareness of psychiatric medications and encourage students to use medications responsibly under professional supervision.
If AU students have problems, they can contact the Counseling Center at x3500 to arrange to speak with a counselor or visit www.american.edu/ocl/-counseling.
