Women who fill prescriptions for custom-blended hormone therapy may get capsules or creams that don’t contain the correct amount of medicine, a recent study suggests.
Researchers focused on what’s known as compounded hormone therapy — prescriptions that are custom-blended by pharmacists instead of factory-made by drug companies and approved for sale by the US Food and Drug Administration (FDA). Sometimes these formulations are marketed as “bioidentical,” and touted as being more like naturally occurring hormones than regular pharmaceuticals.
“Unique concerns about safety surround the use of compounded bioidentical hormone therapy, including the lack of regulation and monitoring, the possibility of overdosing or under dosing, the lack of scientific efficacy and safety data, and the lack of a label outlining risks,” said JoAnn Pinkerton, a professor of obstetrics and gynaecology at the University of Virginia Health system and executive director emeritus of the North American Menopause Society.
“This study showed that the dose of a compounded product received may be different from the actual prescribed dose,” Pinkerton, who wasn’t involved in the research, said by email.
For the current study, Frank Z Stanczyk of the Keck School of Medicine at the University of Southern California in Los Angeles and colleagues tested prescriptions filled at 13 pharmacies for hormone capsules with 0.5mg of estradiol and 100mg of progesterone per gram and for creams with a similar hormone concentration.
In fact, the capsules contained 0.365mg to 0.551mg of estradiol and 90.8mg to 135mg of progesterone per gram. And creams contained 0.433mg to 0.55 mg of estradiol and 93mg to 118mg of progesterone per gram.