FDA panel findings intensify struggles with prescribing of antidepressants

Physicians are urged to warn families of the possible side effects of antidepressants on teens and to monitor patients closely.

By Susan J. Landers, AMNews staff. Oct. 4, 2004.

Washington -- Physicians who treat depressed children and teens are even more carefully weighing the risks and benefits of prescribing antidepressant medications after the Sept. 14 recommendation of two Food and Drug Administration advisory panels that the agency place "black box" warnings on the medications' labels.

After considering evidence from 24 clinical trials, and testimony of numerous physicians and anguished parents whose children committed suicide after treatment with selective serotonin reuptake inhibitors, the Psychopharmacologic Drugs Advisory Committee and the Pediatric Advisory Committee jointly voted 15-8 to recommend that the strongest possible warning be placed on the drugs' labels to alert physicians to their dangers.

If adopted by the FDA, the black-box warning would urge physicians to monitor closely young patients for whom they prescribe SSRIs, particularly at the start of treatment and when doses change.

With child and adolescent psychiatrists in short supply in most of the nation and the increasing recognition that childhood depression can be lethal, many primary care physicians are now grappling with how to treat children. Some physicians say they plan to continue their current prescribing practices, while others say they will be more cautious or might not write these scripts at all.

Earlier warnings and publicity about the safety and efficacy of the antidepressants, for instance, led pediatrician Julianne Thomas, MD, of Cedar Rapids, Iowa, to change her approach. She previously started medication pending an appointment with a psychiatrist, which could take up to six weeks.