Prempro - An Overview

According to its manufacturer, Wyeth Pharmaceuticals, Inc., Prempro®, relieves symptoms of menopause, such as hot flashes and night sweats. Prempro® is a combination hormone replacement therapy (HRT) drug targeted to women with a uterus who are experiencing the side effects of natural menopause. Prempro® was the first estrogen/progestin combination pharmaceutical available for hormone replacement therapy (HRT), and is still one of the most commonly prescribed drugs today.

If you believe that you or a loved one has suffered harm from taking Prempro®, you should consider contacting an experienced product liability attorney from our firm to discuss potential legal claims, which might entitle you to recover for your injuries.

Research Findings Regarding Prempro®

In 1991 the National Heart, Lung, and Blood Institute (NHLBI) formed the Women’s Health Initiative (WHI), a research arm of the NHLBI dedicated to studying the health of post-menopausal women. The WHI began a 15-year longitudinal study of post-menopausal women to determine the best way to address and prevent heart disease, breast cancer and colorectal cancer, and osteoporosis in women. The WHI study performed clinical and observational studies and involved more than 161,000 healthy women.

The WHI directed a hormone therapy study to 68,132 postmenopausal women between the ages of 50-79. A portion of the group was given Prempro® while the remainder received a placebo. The primary focus of this study was to determine if Prempro® aided in the prevention of heart disease and hip fractures due to osteoporosis. In July of 2002, the WHI stopped the Prempro® study because the researchers discovered an increased risk of breast cancer in women taking Prempro®. After weighing the benefits and costs associated with the combined hormone drug, the WHI issued this summary:

The Women’s Health Initiative (WHI) Estrogen plus Progestin Study (E+P) was stopped on July 7, 2002 (after an average 5.6 years of follow-up) because of increased risks of cardiovascular disease and breast cancer in women taking active study pills, compared with those on placebo (inactive pills). The study showed that the overall risks exceeded the benefits, with women taking E+P at higher risk for heart disease, blood clots, stroke, and breast cancer, but at lower risk for fracture and colon cancer.

The Food and Drug Administration (FDA) took the WHI study findings into consideration in approving a lower dose estrogen-progestin medication. In 2003, FDA Commissioner, Mark B. McClellan, M.D., Ph.D., stated:

“…[combined hormone therapy] treatments also have important risks, and should be used in the lowest dose and for the least duration required to provide relief. Today’s action gives postmenopausal women a lower-dose option for getting the benefits of estrogen and estrogen with a progestin treatment.”

Recent FDA Action

The FDA announced in early January 2003 that it was requiring a new “black box warning” labeling for Prempro® as well as updated safety precautions associated with combined hormone HRTs. Black box labeling is the highest precautionary labeling for drugs required by the FDA and is required for medications that are considered to have serious possible risks. The new warning emphasized the increased risk for heart disease, heart attacks, strokes and breast cancer associated with Prempro®.

The new black box labels would also state that Prempro® should not be used to prevent heart disease, should be used the shortest amount of time possible for specific treatment goals, that women taking the drug should have regular check-ups with their doctor to be screened for breast cancer and the medication should be "carefully considered" for use strictly to prevent osteoporosis.

The FDA has not recommended that Prempro® be discontinued nor have they recommended that healthcare providers stop prescribing the drug. The FDA, however, does advise that individuals taking Prempro® discuss the increased risk of disease with their doctor.

If you believe that you or a loved one has suffered harm from taking Prempro®, you should consider contacting an experienced product liability attorney at our firm to discuss potential legal claims, which might entitle you to recover for your injuries.

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