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FDA Updates Hormone Replacement Warnings

February 10, 2004

WASHINGTON (AP) _ The government told makers of hormone replacement therapies Tuesday to add yet another warning to their labels _ that hormones may increase older women’s risk of Alzheimer’s or other types of dementia.

Since last year, products containing estrogen and progestin have had to bear warnings that the hormone combination increases the risk of breast cancer, heart attacks and strokes. Those risks were discovered in a landmark study in 2002 that overturned years of conventional thinking that postmenopausal hormones were generally beneficial.

Estrogen remains an effective treatment for menopausal symptoms such as hot flashes, night sweats and vaginal dryness, but the Food and Drug Administration-written labels urge women to use the lowest possible dose for the shortest amount of time to minimize the risks.

Tuesday, FDA asked manufacturers to add to those labels the results of another study that found hormone supplements don’t keep women’s brains sharp, as was long believed _ long-term users over age 64 actually had a higher risk of dementia.

It isn’t known if using estrogen alone causes similar risks; studies are under way to tell.

But since 2002, FDA has seen a trend by manufacturers toward lower doses of hormone products, said agency medical officer Dr. Theresa Van Der Vlugt.

Also Tuesday, Solvay Pharmaceuticals announced FDA approval of EstroGel, the first gel formulation of estrogen, which is absorbed through the skin of the arm. Hormones delivered through lotions and skin patches also are available.

The FDA doesn’t know if transdermal versions of hormones are safer than pills, but does advise women with vaginal menopause symptoms to consider using vaginal cream versions.

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