In considering the "off-label" use of any medication, it is important to fulfill several criteria for safe use: the condition should have health consequences significant enough to warrant treatment, the treatment should have demonstrated safety and efficacy, and the proposed treatment should be superior to the presently available alternatives. It is also important that the patient and family/guardian be fully informed of the risks, benefits, and alternatives to treatment and that the prescribing physician be very familiar with the medication, its side effects, and possible complications. Under some circumstances, these criteria are fulfilled for the use of metformin in the adolescent with PCOS/FOH. In particular for the obese adolescent with demonstrated insulin resistance, treatment with metformin should be considered since the long-term effects of untreated insulin resistance, obesity, and dyslipidemia have been well documented. Treatment with oral contraceptives alone may not be adequate therapy for the well-documented long-term consequences of PCOS/FOH. What remains to be proven is whether treatment with insulin sensitizers in adolescents with PCOS/FOH will ameliorate these long-term effects. However, given the demonstrated benefits of insulin sensitizers on ovulatory function and obesity, this alone provides justification for off-label use of these drugs.
ASJC Scopus subject areas
- Obstetrics and Gynecology
- Pediatrics, Perinatology, and Child Health