FDA removes black box warning on hormone products

By now most of you are probably aware that last Monday, the FDA made a rather large announcement removing the black box warning from the labels of menopausal hormone therapy products, both local low-dose vaginal estrogen as well as systemic hormones. This was instituted in 2003 shortly after the Women’s Health Initiative news broke. This is a welcomed action. For the last twenty-three years, there has been stigma and fear, not only among patients who may have been excellent candidates for hormone therapy, but also among clinicians unwilling to prescribe, and a paucity of education in medical schools and residency training programs. Thus, I applaud this action. I was not one of the physicians afraid to prescribe hormones. I knew the intricacies of the science as many of you are well aware. 

However, I was extremely concerned about the way Commissioner Makary rolled out the information and the press release that accompanied it. He claimed hormone replacement therapy would result in a 50% reduction in cardiovascular disease and a 35% reduction Alzheimer’s. Nothing could be further from appropriate messaging. The one reference they gave for cardiovascular disease reduction was from 1992. The woman who wrote that paper, ended it by saying what we need are good prospective, randomized trials. The Alzheimer’s reference given in that press release was from 1999 and involved 246 cases of Alzheimer’s. 

Sometimes I am asked if I am “pro HRT” or “anti-HRT.” Nothing could be more absurd. For some people, it is a godsend, for other people, it may be poison. The most important aspect is, “one size does not fit all!” The correct dose, route, and duration should be individualized and be assessed regularly. Low-dose local vaginal estrogen for urogenital symptoms has virtually no systemic absorption and a very strong safety profile. In terms of systemic menopausal hormone therapy, the three most important aspects of caring for such patients are 1) individualize, 2) individualize, 3) individualize! This is the way I have practiced and will continue to practice. 

If this is of value to you or anyone you know, please feel free to pass along this information. 

Dr Steven R. Goldstein is a past President of both the International Menopause Society and the North American Menopause Society and a Certified Menopause Practitioner. He is also the author of the book “The Estrogen Alternative”, the first book that examined the use of Selective Estrogen Receptor Modulators (SERMs) for use as  hormone replacement therapy (HRT) in women. 

As a Menopause Specialist in NYC, Dr Goldstein has helped thousands of women cope with the symptoms of Menopause and Perimenopause over the last thirty years in private practice.