Prempro Side Effects and Lawsuits


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Millions of women suffer from symptoms of menopause ranging from the uncomfortable, such as hot flashes, mood swings, and sleeplessness, to the more serious, such as osteoporosis and colorectal cancer.  One of the first and most popular drug solutions was approved by the FDA for widespread use in 1995.  Manufactured by Wyeth, a unit of Pfizer, Inc., this method of hormone replacement therapy (HRT) has earned Wyeth millions of dollars over the years.  It is a combination of  two hormones, an estrogen and a progestin, that at one time was taken by over 10 million women.  Prempro is taken to relieve the symptoms of menopause in those women who have not yet undergone a hysterectomy.

Risks and Symptoms of Prempro

In 1991, in a study included in the Women’s Health Initiative and sponsored by the National Institutes of Health, it was learned that over the long term, women who used progestin and estrogen, face a greater health danger from a number of diseases, including:

  • Strokes
  • Heart attacks
  • Blood clots
  • Breast cancer

In fact, the study, which was set to run for eight years, was halted after only five, with officials citing a concern that the risks to test subjects was too great.   In response, the manufacturer, Wyeth, promised to increase the warning labels on Prempro packaging.  The FDA required the labels to encourage prescribers to use the product for the shortest period of time possible, that the women using it should have their health monitored regularly, and that the primary purposes for Prempro prescription should include osteoporosis and vaginal dryness and irritation.  All other symptoms of menopause could be addressed more safely with other, less dangerous, products.

Prempro Claims and Lawsuits

Since then, thousands of women have filed private lawsuits against Wyeth and Pfizer, citing serious medical complications.  Two class actions suits have been filed, but as of yet, neither has received certification.  As a result, while Prempro is still on the market, the courts are well aware of the dangers it poses.  Two recent ground-breaking lawsuits received sizable awards.  A case in Philadelphia resulted in a $28 award for punitive damages to a woman suffering from breast cancer after 11 years of Prempro use.  Another case, whose final review is pending, was initially awarded $75 million in punitive damages along with $3.5 million in compensation. 

Legal Help from a Lawyer

There may be additional thousands of women suffering the consequences of using a drug they thought was helpful, not harmful.  These women have the right to contact a personal injury lawyer or a product liability attorney to learn if they have grounds to file suit, as well.  There are a number of considerations, including the statute of limitations, which differs from state to state, setting a time limit within which a victim must file their claim.  It is important to seek help soon, before time runs out, to be guaranteed the compensation due to those injured by the negligence of these manufacturers.

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