FDA approves low dose of hormone drug

The Associated Press
Jun 9, 2003 : 6:18 pm ET

MADISON, N.J. -- Federal regulators have approved a lower-dose version of Prempro, a popular hormone replacement drug whose sales have plunged since several studies found more health risks and fewer benefits than expected.

Prempro, a combination of the hormones estrogen and progestin made by Wyeth Pharmaceuticals, part of Madison, N.J.-based Wyeth, can ease moderate-to-severe menopause symptoms.

Wyeth said Monday the Food and Drug Administration has approved the sale of Prempro pills containing 0.3 milligrams of estrogen and 1.5 milligrams of progestin. The standard strengths have 0.625 milligrams of estrogen and 2.5 milligrams or 5 milligrams of progestin.

Health officials and Wyeth are now recommending that women choosing hormone replacement therapy take the lowest effective dose for the shortest time possible to limit heart and other risks, so the new version could help reverse sagging sales.

Wyeth, which dominates the hormone replacement market, also said Monday that the FDA has added prevention of osteoporosis to the approved uses of a moderate dose of Prempro that has 0.45 milligrams of estrogen and 1.5 milligrams of progestin. That pill was approved in March for treating menopause symptoms.

Wyeth said it expects to have the 0.45 milligram dose of Prempro available early this summer and the 0.3 milligram dose available late this year.

Three studies published in July 2002 cast doubt over Prempro's effectiveness and contributed to a drop in Wyeth's stock price.

Last week, Wyeth launched a nationwide ad campaign saying the therapy remains helpful for many menopausal women. The ads said that hormone therapy is proven to ease menopause symptoms, but is not right for all women.

The biggest of the three studies, the Women's Health Initiative, reported that women taking Prempro had higher-than-expected incidence of breast cancer, heart attack, stroke and blood clots, but reduced risk of hip fractures and colon cancer.

While the risks to an individual woman were still relatively low, the National Institutes of Health, which sponsored the study, urged the 6 million women taking estrogen-progestin pills to consult with their doctors.

Other studies showed estrogen and progestin pills doubled the risk of Alzheimer's disease in women 65 and older and don't make older women feel better by improving their memory, sleep or sex lives, as doctors had believed.

On Monday, Wyeth shares fell $1.44, or 3 percent, to close at $46.71 each on the New York Stock Exchange.