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Similar to men prescribed AndroGel to treat decreased testosterone levels, only to potentially experience heart attacks and other adverse cardiac conditions, women had been recommended Prempro hormone replacement therapy to treat menopause symptoms.

However, a large federal study found Prempro increased women’s risk of breast cancer development by 26 percent, heart attacks by 29 percent, strokes by 41 percent, and blood clots in legs and veins by 105 percent.

As a result, lawsuits filed at federal and state levels target Wyeth Pharmaceuticals and Pfizer’s marketing tactics and underplaying side effects.

Background

The FDA approved Prempro in 1994 for protecting against heart disease, but the drug ended up on the market without randomized clinical trials. Labels, as well, claimed the drug had been approved to treat menopause symptoms.

Prempro, a combination of premarin (estrogen) and progesterone, replaces hormones lost during menopause to supposedly relieve such common symptoms as hot flashes, mood swings, and night sweats. Over the years, six million U.S. women have used the drug, which remains the No. 1-selling HRT treatment.

Yet, multiple studies conducted over 15 years show a correlation between Prempro and increased cancer and cardiovascular risks, particularly that women who underwent this form of HRT for three or more years were four times as likely to develop lobular breast cancer.

In 2002, the National Heart, Lung and Blood Institution intentionally halted a major clinical trial because of the risks associated with combining the two hormones, as well as an increase in breast cancer when compared with the placebo group.

A year later, a Women’s Health Initiative found similar links. Specifically, patients who took Prempro for five or more years were placed at a greater risk for myocardial infarction, stroke, invasive breast cancer, blood clots, and deep vein thrombosis. As a result, the FDA required Wyeth to change the medication’s label.

Along with these associations, Prempro is associated with other complications:

  • Ovarian and gallbladder cancer
  • Lupus
  • Non-Hodgkin’s Lymphoma
  • Scleroderma
  • Veinous thrombosis
  • Pulmonary embolism
  • Asthma

Doctors have been recommending hormone replacement therapy to treat menopause for more than 50 years, and prior to 2002, it was considered to protect women against heart disease and osteoporosis. However, with Prempro, medical authorities suggested women begin taking it right at the onset of this age-related condition and continue using it for several years after.

Lawsuits

Although Prempro continues to remain on the market, with limited, observed treatment, lawsuits have targeted Wyeth’s practices, alleging the drug manufacturer overstated this HRT’s benefits while underplaying risks, paying scientific publications to excessively promote it, and marketing it for off-label uses.

Dating back to 2007, 13,000 people have sued Wyeth and Pfizer at state and federal levels for punitive and compensatory damages.

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