US Orders New Youth Warnings on Antidepressants

The U.S. government ordered antidepressant makers on Friday to put tough warnings on the drugs to alert doctors, parents and patients the medicines increase risks of suicidal behavior among children and teens.

The Food and Drug Administration said the information, to be written in bold letters and highlighted in a black box, must also state whether the drug has been cleared for use by children. Only Eli Lilly and Co.’s Prozac is FDA-approved for treating pediatric depression. The new warning labels should appear in the next month or two, the FDA said. Some mental health groups and drug makers expressed reservations about using a black box, the strongest warning the United States can put on prescription drugs. Noting that depression itself elevates suicide risk, the American Psychiatric Association worried the boxed warning “may have a chilling effect” for patients who could benefit from the drugs. “This would put seriously ill patients at great risk,” the group said in a statement. The warning will stress the need to monitor the behavior of youths who start taking the medications. The chances of suicidal behavior appear greater during the first few months of treatment, the FDA said in a statement. “The new warning language does not prohibit the use of antidepressants in children and adolescents. Rather, it warns of the risk of suicidal (behavior) and encourages prescribers to balance this risk with clinical need,” the FDA said. The warnings will apply to all antidepressants “because the currently available data are not adequate to exclude any single medication from the increased risk,” the FDA said. The agency is developing a pamphlet explaining the safety risks in patient-friendly language for distribution with each antidepressant prescription or refill. To make sure patients receive the pamphlet, the FDA told manufacturers to devise special packaging that contains only one course of therapy, rather than distributing the drugs in bulk. Patients will get a container sealed by the drug maker with the pamphlet included. Drug companies will need to convey the information in the black box in television and print advertisements. They also will be forbidden from running “reminder ads” for the drugs that mention the product name but do not explain benefits and risks, FDA officials said. More than 10 million antidepressant prescriptions were written in 2002 for children ages 1 through 17, the FDA estimates. In clinical trials of nine antidepressants, none of the more than 4,400 children or teens actually committed suicide. But 4 percent reported suicidal thoughts or behaviors, compared with 2 percent of those who were given a placebo. In the event of unusual behavior, patients or their parents should contact their physicians, the FDA advised. Treatment should not be abruptly halted, officials said. The FDA has been criticized for being slow to recognize the link between the drugs and suicidal thoughts and actions. One agency reviewer warned about the danger months ago, but top officials did not acknowledge a connection until September. The new safeguards closely follow the recommendations of a committee of outside experts that urged the FDA to require prominent warnings. Top-selling antidepressants include Prozac, Pfizer Inc.’s Zoloft, Wyeth’s Effexor and GlaxoSmithKline Plc’s Paxil. Prozac also is sold generically under the name fluoxetine. (Source: Reuters Health News: Lisa Richwine: October 2004.)