Wyeth Changes HRT Labels to Reflect Cancer, Heart Disease Risks

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Wyeth Changes HRT Labels to Reflect Cancer, Heart Disease Risks

ST. DAVIDS, Pennsylvania (Reuters) Sept 04 - Drugmaker Wyeth on

Wednesday said it changed the prescribing recommendations for women

taking its hormone replacement therapy products to reflect recent

findings that raised safety concerns about the medicines and sparked a

nationwide debate.

The labels for Premarin, Prempro and Premphase will now recommend that

women remain on the therapies for the shortest duration possible given

the individual patient's treatment goals.

The drugs should also not be taken to prevent heart disease, and other

treatments should be considered to prevent osteoporosis, the labels now

state.

The prescription information will include results of a study spearheaded

by The Women's Health Initiative that suggested Prempro carried a

slightly increased risk of breast cancer, stroke and heart disease after

five years of use. A second study prompted safety questions about

Premarin.

Premarin contains estrogen, while Prempro combines estrogen with

progestin.

Wyeth, which saw US prescriptions drop more than 20% in the weeks

immediately after the Prempro study came out in July, has been

criticized for not adequately warning patients of the potential risks of

the medicines.