Prempro is a hormone replacement therapy (HRT) designed to replace hormones lost during menopause and to relieve physical symptoms such as hot flashes, mood swings and night sweats. In the past several years, Prempro has been the target of thousands of Prempro heart disease and Prempro breast cancer lawsuits, and a nationwide class action lawsuit has been filed against Wyeth Pharmaceuticals (now Pfizer).
As well, a number of other adverse health consequences have been reported including ovarian and gall bladder cancer, lupus, non-hodgkins lymphoma, heart attack, sclerederma, venous thrombosis, pulmonary embolism and asthma.
It is estimated that 6 million American women use Prempro, a combination of premarin (which is estrogen) and progesterone. In 2001, approximately 22.3 million prescriptions were written for Prempro to treat post-menopausal hot flashes and other menopause symptoms.
By the mid-1990s, the labels for Prempro and Premarin hormone drugs claimed that the drugs were approved by the FDA to treat moderate to severe menopause symptoms, such hot flashes, and to prevent osteoporosis.
In July 2002, the National Heart, Lung and Blood Institute (NHLBI) announced that it had stopped a major clinical trial of the risks and benefits of combined estrogen and progestin-- Prempro was the only estrogen/progestin combination drug tested in the study. (The study was supposed to continue until 2005.) The NHLBI study found a marked increase in breast cancer for women who were taking Prempro compared to those in the placebo group.
In 2003, following a study conducted by the Women's Health Initiative (WHI) showing these links, the FDA required Wyeth to change Prempro's labeling to include information from the WHI study – specifically that the drug may increase the risk of myocardial infarctions (heart attack), stroke, invasive breast cancer, pulmonary embolism (blood clots), and deep vein thrombosis (deep vein blood clots) in postmenopausal women who take the drug for more than 5 years.
On December 12, 2009 The New York Times reported that recently examined court documents from HRT lawsuits argued that Wyeth oversold the benefits of its menopausal hormone drugs while failing to warn of their risks. According to the NYT, documents show that Wyeth spent tens of millions of dollars—such as paying influential physicians, scientific publications and celebrity ads--promoting Prempro with positive preventive health messages.
In November 2009, a Philadelphia jury ordered Pfizer to pay $6.3 million in compensatory damages to an Illinois breast cancer survivor after finding menopause drugs Premarin, Provera and Prempro caused the disease.
In October 2009, a jury in a Pennsylvania state court awarded a woman $75 million in punitive damages from Wyeth on top of compensatory damages of $3.75 million. The suit asserted that Wyeth oversold the benefits of menopausal hormones and failed to properly warn of the risks.
In October 2007 a Nevada jury awarded $134.5 million to three women who developed breast cancer following use of Prempro and Premarin. The verdict was the largest against drugmaker Wyeth related to its hormone replacement therapy. A fourth woman settled before trial and passed away in April 2007 at the age of 59.
In February 2007a jury in Philadelphia found that Prempro caused Jennie Nelson's breast cancer and awarded her and her husband $3 million in damages. Nelson previously had been awarded $1.5 million by a jury in October 2006, but a mistrial was declared after the verdict had been returned.
In January 2007 a Philadelphia jury found that Prempro was responsible for Mary Daniel's breast cancer and ordered Wyeth to pay $1.5 million in compensatory damages. The jury concluded that Wyeth was negligent in failing to provide adequate warnings about the risk of breast cancer associated with Prempro.
Even though Wyeth has received thousands of warnings and lawsuits linking Prempro to breast cancer, strokes and other serious illnesses, the drug remains on the market. Experts believe that Wyeth has known of the adverse events caused by Prempro for many years, but it has chosen profits over safety—in 2006 and 2007, Prempro sales were over $1 billion.
Now, many doctors limit hormone therapy to women with specific menopause symptoms and do not prescribe Prempro and other HRT drugs beyond menopause.
If you or a loved one has suffered a serious illness as a result of taking taken progestin or a combination of progestin and estrogen, you may qualify for damages or remedies that may be awarded in a Prempro class action or lawsuit.