Prempro (Hormone Replacement Therapy)

During menopause, women's estrogen levels decrease. This decrease has interested doctors and patients for many years. Synthetic estrogen was developed in the 1920's and by the 1930's was being used to relieve menopause symptoms. In the 1970's, the use of Hormone Replacement Therapy decreased sharply when the connection between the use of synthetic estrogen and elevated risk of endometrial cancer was recognized. Hormone Replacement Therapy increased again in the 1980s when long-term research established positive effects of Hormone Replacement Therapy against osteoporosis and possibly heart disease.

Physicians are prescribing lower doses of estrogen to minimize the risk of endometrial cancer. In addition, different formulations and dosing schedules have permitted physicians to better tailor HRT to each patient.

A federal study released in July of 2002, included findings that long-term use of the popular menopause treatment leads to an increased risk of breast cancer, heart disease and strokes. This study, called HERS (Heart and Estrogen/Progestin Replacement Study) showed that taking Premarin and Provera, in combination, commonly called, Prempro, actually increased the risk of heart disease during the first year of Prempro therapy for women with pre-existing heart disease. The federal study, done by the National Institute for Health and paid for the The National Heart, Lung and Blood Institute, was abruptly ended three years early. Findings of significant increases in heart attacks, strokes and breast cancer among women on the drug versus those on placebo was conclusive enough to preclude further testing. The long-held assumption that Prempro prevents heart attacks is now disproved.

Eight-five percent (85%) of women taking estrogen-progestin therapy are prescribed Prempro. The name "Prempro" comes from the prior drugs of Premarin and Provera. Prempro is manufactured by Wyeth Laboratories.

Although there are no present plans to recall Prempro, in 2003, the FDA required labeling revisions as part of a series of actions to provide risk management information to women and to advise health care providers. The FDA's new labeling changes include a new BOXED WARNING that reflects new risk information and changes to the approved indications to emphasize individualized decisions that appropriately balance the benefits and the potential risks of these products. The new boxed warning highlights the increased risks for heart disease, heart attacks, strokes and breast cancer. The warning also emphasizes that the products are not approved for heart disease prevention. The FDA has also modified the approved indications for Premarin, Prempro and Premphase to clarify that these drugs should only be used when the benefits clearly outweigh risks.

The FDA has recommended that those woman using or considering estrogens or estrogen-progestin treatment should consult with her health care provider about the implications of the new information on risks and benefits in her case

If you or a loved one has been diagnosed with breast cancer, ovarian cancer, lupus or scleroderma since using Premarin, Prempro or Premphase and would like an attorney to evaluate your claim, contact Davis & Feder P.A. at 1-866-857-8500.

PREMPRO (HRT) LINKS:

July 2002 Women's Health Initiative

Breast cancer information

Breast cancer treatment

Ovarian cancer information

Ovarian cancer treatment