Compounded bioidentical hormone therapy: Does the regulatory double standard harm women?
While use of menopausal hormone therapy products has trended downward in recent years, evidence suggests U.S. women increasingly are turning to compounded bioidentical hormone therapy (cBHT) to combat hot flashes and other symptoms.
While use of menopausal hormone therapy products has trended downward in recent years, evidence suggests U.S. women increasingly are turning to compounded bioidentical hormone therapy (cBHT) to combat hot flashes and other symptoms. Pharmacists polled last year, for example, estimated that 26 million–33 million cBHT prescriptions are filled each year. The problem, warn Cynthia A. Stuenkel, MD, of the University of California, San Diego, and JoAnn E. Manson, MD, DrPH, of Harvard Medical School, is that cBHT has been demonstrated neither as safe nor effective and, therefore, has not been sanctioned by FDA as such. Considering that cBHT is not a proven intervention and that there are numerous FDA-approved bioidentical menopausal hormone therapies (BHT) that actually have been shown to help women, the authors question why patients are leaning toward cBHT. One reason, they suggest, is that some women are not fully informed, with many wrongfully believing the therapy has an FDA stamp. Meanwhile, hormones that are approved by the agency carry a "black box" warning detailing potential risks. Because compounded products are not under FDA authority, they are not required to bear such labels—but perhaps they should be, Manson and Stuenkel argue. They urge state pharmacy boards to take the lead by requesting that compounding pharmacists include a patient package insert when dispensing cBHT. Otherwise, they add, state legislatures could pursue legislation making such disclosures mandatory; or Congress could empower FDA with full legal authority over cBHT products.