Prescription of antidepressants for children and adolescents by office-based physicians is typically done off-label
Pediatricians and other health care providers often prescribe antidepressant drugs off-label to children and adolescents, concludes a new study. Drugs prescribed off-label are those not approved for that particular indication or population by the U.S. Food and Drug Administration (FDA). The use of antidepressants in children and adolescents aged 6–18 years old has grown dramatically in the past decade, in small part due to FDA approvals for a handful of conditions. However, only 12 of 32 FDA-approved antidepressants have FDA approval for treating pediatric depression or are approved for use with patients at least 6 years old with obsessive–compulsive disorder or enuresis (bedwetting). Physicians can prescribe medicines for indications (or populations) for which the drug lacks FDA approval, and this study observed a high prevalence of off-label antidepressant prescribing for children and adolescents by office-based physicians.
The researchers analyzed data from the National Ambulatory Medical Care Survey from 2000 to 2006 to examine off-label prescribing patterns of antidepressants for children and adolescents. They found that among physicians' visits made by the pediatric study population, 3.7 percent involved prescribing, providing, or continuing any of the 12 drugs approved for an indication in pediatric patients ("antidepressant visits"). When the researchers looked only at the antidepressant visits, only 9.2 percent (or 0.34 percent of all visits) involved FDA-approved pediatric indications with age specification. Attention deficit-hyperactivity disorder was the most frequently associated off-label indication (35.5 percent), followed by depression (35.2 percent), and other diagnoses (including bipolar disorder, anxiety, oppositional defiant disorder, and affective psychosis).
Visits to pediatricians were 2.4 times more likely to be associated with off-label antidepressant orders than were visits to pediatric psychiatrists. Visits to general and family practitioners and to all other specialists resulted in off-label antidepressant prescriptions 1.9 times more frequently than did visits to pediatric psychiatrists. The researchers suggest that the lack of available approved drugs for the pediatric population may account for much of this off-label prescribing. The study was supported in part through a grant from the Agency for Healthcare Research and Quality (HS11673).
More details are in "Off-label prescribing patterns of antidepressants in children and adolescents," by Euni Lee, Pharm.D., Ph.D., Anna R. Teschemaker, Ph.D., Rosemary Johann-Liang, M.D., and others in the February 2012 Pharmacoepidemiology and Drug Safety 21(2), pp. 137-144.