Meeting of the FDA Psychopharmacological Drugs Advisory Committee and the FDA Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee Regarding Suicide and the Use of Antidepressants by Children
The widespread use of antidepressant drugs by children and youth in the United States is cause for great concern. Data that have been recently analyzed by the Food and Drug Administration (FDA) indicate that children who took one of several popular antidepressants for a short time were twice or three times as likely to have serious suicidal thoughts and behaviors.
This depressing situation is made worse by the approach that FDA has taken thus far: cautiously protecting the pharmaceutical companies rather than cautiously protecting the patients. At this point, there is no persuasive evidence that most antidepressants are effective or safe for children, and no evidence that the benefits outweigh the risks. However, rather than require labels that make this situation clear, the FDA has thus far issued a Talk Paper that merely reminds “physicians, their patients, and families and caregivers of patients about the need to closely monitor both adults and children with depression, especially at the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose.”
Our children’s lives are at stake. Physicians that prescribe antidepressants spend little time with their patients, and therefore do not closely monitor them. Children talking anti-depressants are in school at least 6 hours each day, and therefore not available for parents to closely monitor their activities. And of course, adolescents are inherently difficult to “monitor closely.”
Our children’s lives are at stake. Physicians that prescribe antidepressants spend little time with their patients, and therefore do not closely monitor them. Children talking anti-depressants are in school at least 6 hours each day, and therefore not available for parents to closely monitor their activities. And of course, adolescents are inherently difficult to “monitor closely.”
Depression is a very serious, debilitating disease that can be fatal. Antidepressant drugs are not the only option. Years of research has shown that cognitive behavioral therapy is a very effective treatment for depression. However, I know from my experience as a university researcher that not all therapists used in clinical trials are experienced and effective, and that will influence the outcome of those studies. In addition, Prozac has some evidence of safety and effectiveness with adolescents. It is therefore absolutely essential that well-designed research studies compare the effectiveness of Prozac and other antidepressant drugs to cognitive behavioral therapy by experienced therapists, as well as to placebo. In the meantime, patients and their families need warnings indicating the increased risk of suicidal thoughts and behaviors on every bottle of several popular anti-depressants.
The National Research Center for Women & Families uses research information to advocate for programs and policies that will improve the health and safety of women, children, and families. The Center does not take contributions from companies whose products it praises or criticizes. The goal is to safeguard health and help consumers make educated choices.