A Hormone Is a Hormone, F.D.A. Says

[Guest guest]

January 9, 2008, 6:27 pm

http://well.blogs.nytimes.com/2008/01/09/a-hormone-is-a-hormone-fda-says/A Hormone Is a Hormone, F.D.A. Says

Menopause hormones mixed by pharmacists aren’t any safer than commercially prepared hormones from drug companies, the Food and Drug Administration said today.

The message is important because for the past few years, pharmacists, consumers, celebrities and even some doctors have been touting so-called bioidentical hormones as a safer alternative to standard hormones for treating menopause symptoms. Sitcom star Suzanne Somers, for example, has stirred controversy with two books claiming all sorts of health benefits from the custom-mixed drugs.

But the F.D.A. announcement supports the notion that a hormone is a hormone. It doesn’t matter whether it’s mixed by a pharmacist or sold by a drug firm. The risks and benefits are the same.

Hormones sold by pharmacists are often called “bioidentical†or “natural†because, though they are derived from plants, they are a chemical match to the estrogen or progesterone made in a woman’s body. However, commercial drug companies also offer bioidentical brands that use estradiol (a form of estrogen) or progesterone.

The real difference here is that pharmacists custom-mix, or compound, hormones from scratch while pharmaceutical firms produce standard versions of their drugs. Custom-mixed hormones have surged in popularity since a government study five years ago raised questions about the health risks associated with traditional menopause hormones made by drug companies. That study showed that menopause hormones carry a higher risk of blood clots and stroke, and that estrogen and progestin used in combination raises a woman’s risk for breast cancer.

Compounding pharmacies serve an important function in the health care system. They prepare custom-mixed drugs for patients who for some reason can’t use commercial drug products. For instance, compounders might make a chewable tablet or allergy-free version of a medicine.

But the compounding business in recent years has surged into a significant player in menopause treatment. Nobody knows how much of the prescription hormone market now goes to compounders, but sales of commercial prescription drugs have fallen by about half since 2002, when the first health risks were reported.

About two years ago, pharmaceutical giant Wyeth, the biggest seller of prescription menopause hormones, asked the F.D.A. to take action against compounders, which it said weren’t being adequately regulated. Although drug companies fall under F.D.A. rules, compounding pharmacies are regulated by states.

In response to the Wyeth complaint, an estimated 50,000 comments flowed into the F.D.A., many of them from women who were convinced compounded hormones are safer and more effective than commercial hormones.

The F.D.A. statement means compounders can’t claim their products are superior to commercial drugs. In addition, the agency told compounders they can’t offer products that contain a form of estrogen called estriol, which is approved in Europe but not the United States. The agency sent warning letters to seven pharmacies it said were making estriol products.

The moves fall short of Wyeth’s request that the F.D.A. start regulating large compounding pharmacies the way it monitors drug firms. But the F.D.A. did tell Wyeth it could educate consumers about the risks of compounded hormone drugs. Wyeth and some major medical groups have raised concerns that compounded drugs may carry extra risks because there’s no oversight of their production.

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