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PREMPRO
Prempro is a hormone replacement therapy (HRT) made up of a combination of estrogens and a progestin, that has been linked to increased chances of breast cancer, heart disease and stroke. Other adverse health consequences have been reported, including ovarian and gall bladder cancer, lupus, nonhodgkins lymphoma, heart attack, sclerederma, venous thrombosis, pulmonary embolism and asthma.
HRT is designed to replace hormones lost during menopause and relieve physical symptoms such as hot flashes, mood swings and night sweats.
Wyeth, Inc. (f/k/a American Home Products) and Wyeth Pharmaceuticals (f/k/a Wyeth-Ayerst Pharmaceuticals, Inc.), the manufacturers of the prescription hormone replacement therapy (HRT) drug Prempro, have had a nationwide class action lawsuit filed against them.
Approximately 22.3 million prescriptions were written for Prempro in 2001, to treat post-menopausal hot flashes and other menopause symptoms.
The National Heart, Lung and Blood Institute (NHLBI) announced on July-09-02, that it stopped a major clinical trial of the risks and benefits of combined estrogen and progestin. Data revealed that there were marked increases in invasive breast cancer, coronary heart disease, stroke and pulmonary embolism in patients taking Prempro compared to women taking a placebo.
The NHLBI study involved 16,000 women ages 50 to 79 that had not undergone a hysterectomy. Prempro was the only estrogen/progestin combination drug tested in the study. Women participating in the study were not given other brands of HRT drugs that had lower doses of estrogen or estrogen skin patches. The study found increased risks associated with the following:
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Strokes - 41% Increase
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Heart Attacks - 29% Increase
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Blood Clots - 105% Increase
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Heart Disease - 22% Increase
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Breast Cancer- 26% Increase
When the Data and Safety Monitoring Board (DSMB) held its bi-annual meeting to review the study's data, they decided to discontinue the study. Previous DSMB reviews revealed increased rates of coronary heart disease, strokes and blood clots. However, at the May 31st meeting, the DSMB reviewed data collected through February, 2002, which revealed for the first time a marked increase in breast cancer for women who were taking Prempro compared to those in the placebo group.
PREMPRO NEWS
Ellen Deutsch, who took Prempro and its predecessor, Premarin, for seven years and was eventually diagnosed with breast cancer, has filed suit against drugmaker Wyeth. (Jul-16-07) NJ: PREMPRO CANCER RISK
Results from a Women's Health Initiative 2002 study linked Prempro to a 24% increase in risk for invasive breast cancer and other health risks. (Jun-29-07) KAISER NETWORK: PREMPRO
Two new reports add to evidence that hormone replacement therapy, such as Prempro, increases cancer risks. Investigators say that a continued decline in breast cancer diagnoses corresponds to a similar decline in HRT use. (Apr-19-07) WIRED: PREMPRO BREAST CANCER
Ohio woman awarded $3 million verdict by a jury which decided that her use of Wyeth’s menopause drug, Prempro, led to her breast cancer. (Feb-20-07) NEWS INFERNO: PREMPRO
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