Use of potentially risky, non-FDA approved hormone therapies may soon be as common as use of FDA-approved hormone therapies, according to a study by University of Virginia gynecology researcher JoAnn Pinkerton.
, recent consumer and pharmacy data from the above survey "suggest that there has been a sharp increase in the use of compounded menopausal hormone therapies since 2002, and that there is a lack of awareness that these compounded formulations, which require a prescription, are not approved by FDA
noted that "all" the major medical societies (ACOG, the Endocrine Society
, NAM, ASRM) "recommend FDA-approved well-studied therapies as first line due to published data on safety, efficacy, and presence of labels and black box warnings when appropriate.
However, some providers may believe the hype and myths that compounded therapies are 'safer than approved therapies' and, 'have no risks' or 'fewer risks' despite the absence of well-controlled clinical trial efficacy and safety data on the compounded products themselves."
In other words, Pinkerton
said, "Providers may not be aware of unique risks associated with compounding."
There are many dangers here, said Pinkerton
"Unsubstantiated claims lead women to think that these products have no risk, low risk or may even prevent cancer.
For example, she
said, a compounded form of an estrogen called estriol "has been touted to prevent breast cancer without any data to back up the claim.
Estriol is a weak estrogen but has potential to stimulate breast and uterus if dosed high enough."
University of Virginia gynecologist and researcher JoAnn Pinkerton, M.D. (Source: University of Virginia)
The lack of a label or any warning about "risks of the hormone therapy, relative and absolute contraindications, along with a lack of understanding of unique risks associated with compounding, may lead to a false sense of safety or security," Pinkerton
said, potential risks of compounded hormone therapies "beyond the lack of rigorous testing, thus limiting safety and efficacy data and lack of appropriate labeling, regulation or monitoring, include possible presence of contaminants, lack of sterility, and concerns of overdosing or underdosing, which could increase health risks such as cancer."
In short, Pinkerton
said, FDA-approved menopausal hormone therapies provide "tested and regulated therapy, while compounded therapies provide less tested and less well regulated therapies."
Patients can protect themselves by checking box labels, said Pinkerton
emphasized, like Lobo, that all major medical societies "with menopausal specialists are unanimous that FDA-approved estradiol and progesterone therapies are preferred."