Common Hormone Therapy Not Proven Safe for Menopausal Women

Compounded hormone therapy often used in menopause by patients who were not informed of potential risks

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Women considering hormone therapy may need to speak to their doctors about the safety of their treatment options.

A new study found that most menopausal women using compounded hormone therapy (CHT) were not aware that these medications were not proven to be safe and effective.

Using two surveys, the authors of this study found that women using CHT did not know that the US Food and Drug Administration, or FDA, had not approved the therapy.

“Providers have an educational opportunity to ensure that women considering hormone therapy understand the risks and benefits of inadequately regulated CHT,” wrote the authors of this study, conducted by JoAnn V. Pinkerton, MD, of the University of Virginia in Charlottesville, and Nanette F. Santoro, MD, of the University of Colorado School of Medicine in Aurora.

Tiffany Jackson, MD, a gynecologist at Baylor Medical Center at Garland in Texas, told dailyRx News that "A woman may choose to take compounded bioidentical hormone therapy because she has been informed or believes that these hormones are lower risk because they are 'more natural.' Furthermore the idea of having a formulation that is custom made for you according to your biochemical profile is very appealing to many women."

Between one and 2.5 million women in the US use CHT during and after menopause, Drs. Pinkerton and Santoro wrote.

Hormone therapy can help treat symptoms caused by changing levels of hormones tied to menopause, such as hot flashes, migraines and reduced sex drive. Most hormone therapy prescriptions are for FDA-approved formulations containing estrogen and/or progestin, like Premarin.

However, so-called "bioidentical" hormone therapies, or CHT, have not been approved by the FDA. CHT is custom-compounded by the pharmacist, so the formulations vary widely. These therapies are not closely regulated.

The FDA tests treatments and only approves them if they appear safe and effective. Once a treatment is FDA-approved, problems caused by the treatment can be reported to the government.

For this study, Dr. Pinkerton and team gave two surveys to women age 40 or older.

The first survey, given to just over 2,000 women who used either FDA-approved or bioidentical hormone therapy, asked whether patients believed CHT was FDA-approved. Only 14 percent of respondents said no, while 76 percent said they were not sure.

Of the women in this study using hormone therapy, 25 percent were using formulations not approved by the FDA.

Dr. Pinkerton and colleagues also found that CHT accounted for between 28 and 68 percent of hormone therapy prescriptions.

The second survey, given to just over 800 women, found that most women had discussed menopause symptoms and treatment with their doctors.

Dr. Jackson told dailyRx News about her experiences with women who use CHT, saying that "... women who are taking bioidentical hormone therapy ... experience improvement in their symptoms, however ... women who take traditional hormone therapy ... also have improvement in their symptoms. Women who take bioidentical hormone therapy often feel like they are using a safer or more effective treatment than traditional hormone therapy."

Dr. Jackson said women should be aware of the risks and alternatives in hormone therapy.

"I would counsel a woman who wishes to use bioidentical hormone therapy that the medication is not approved by the food and drug administration and has not been well studied for side effects, and that it is not superior to or safer than traditional hormone therapy, but many women use it and have improvement of their symptoms," she said. "If a woman wishes to use compounded hormone therapy rather than traditional hormone replacement therapy I would want to make sure that she is aware of the risks and that there are alternatives.

"Compounded bioidentical hormone therapy often is not covered by prescription plans, so I would want to make sure that patients understand that they may end up paying more money for hormone therapy when traditional hormone therapy could be cheaper, effective and safer," Dr. Jackson concluded.

Doctors should talk to their patients about whether a therapy has been proven safe or effective, Dr. Pinkerton and team said.

"These results indicate a general lack of understanding about key differences between compounded and FDA-approved hormone therapy," said Dr. Margery Gass, executive director of the North American Menopause Society, in a press release. "This publication establishes the need for better education on this topic."

This study was published Feb. 19 in the journal Menopause.

TherapeuticsMD funded this research. The study authors said they had financial ties to TherapeuticsMD and other pharmaceutical companies.

Review Date: 
February 18, 2015
Last Updated:
February 24, 2015