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On April 10, 2003, the Food and Drug Administration (FDA) announced that it was beginning legal procedures to remove the marketing authorizations for combination drug products containing estrogen and androgen, female and male hormones respectively. Estrogen and androgen combination products had been approved for the treatment of moderate to severe “hot flashes” (vasomotor symptoms) associated with the menopause in women whose symptoms were not improved by estrogen alone.
The only...
On April 10, 2003, the Food and Drug Administration (FDA) announced that it was beginning legal procedures to remove the marketing authorizations for combination drug products containing estrogen and androgen, female and male hormones respectively. Estrogen and androgen combination products had been approved for the treatment of moderate to severe “hot flashes” (vasomotor symptoms) associated with the menopause in women whose symptoms were not improved by estrogen alone.
The only estrogen-androgen combination product remaining on the U.S. market is esterified estrogens with methyltestosterone (ESTRATEST, ESTRATEST HS).
Estrogen only drugs are approved for the treatment of moderate to severe hot flashes associated with menopause. The FDA is taking this action because it no longer believes that there is substantial evidence that androgens contribute to the effectiveness of these combination products to treat hot flashes in menopausal women who do not find relief from these symptoms when using estrogens alone.
The legal standard for approving a drug in the U.S. is substantial evidence that the drug is safe and effective for its intended use. The standard used for approving combination products is that the combination must be shown to be more effective than the individual ingredients. The weight of the evidence now shows that estrogen-androgen combination drugs are not superior to estrogen in reducing the vasomotor symptoms of menopause. One researcher commented in 1997 that “Studies suggest that estrogen is primarily responsible for reductions in vasomotor symptoms and that the addition of androgen neither improves nor detracts from this beneficial effect.”
If the androgen in estrogen-androgen combination products does not result in a benefit for women, then all that is left from the androgen are its risks and these risks are not insignificant. The FDA’s thinking at this time is that androgen can reverse the favorable impact of estrogen on cholesterol and triglycerides (fats in the blood). Androgen is also associated with abnormal hairiness, acne, deepening of the voice, and hair loss in women.
We agree with the FDA’s decision to remove the marketing authorizations for combination drug products containing estrogen and androgen; however, the issue over the effectiveness of these combinations goes back for decades and this action by the FDA is long overdue.
The FDA has had a longstanding policy to allow the continued marketing of drug products while matters such as these are being resolved, provided there is no documented serious public health or safety issue associated with such products. In our opinion this policy is irresponsible. It is pro-business, not pro-public health and safety. There is no justification for leaving products on the market when there are questions of effectiveness such as the estrogen-androgen combinations.
What You Can Do
You should consult your physician if you are now using an estrogen-androgen combination product to control the vasomotor symptoms of menopause.
Do not succumb to promotions of compounding pharmacists and the physicians that work with them that the estrogen and androgen products they prepare in their back rooms are effective and without adverse effects.
