2005 Update - Judge Approves Prempro Class Action.
Wyeth Appeals Decision
In February 2005, Miami-Dade Circuit Judge Lawrence Schwartz approved the class action consolidation of Prempro lawsuits, covering an estimated 300,000 Floridians who took Prempro for at least six months prior to health warnings placed on the product in January 2003. The lawsuit is the first nationally to get class-action clearance among about 20 lawsuits seeking it.

The lawsuit was filed shortly after the 2002 release of the critical Women's Health Initiative study, which showed increased risk of heart attack, stroke, breast cancer, cardiovascular disease and embolisms among Prempro users. The suit claims more than 9,000 of the 300,000 Florida women who took Prempro for at least six months will develop preventable diseases in the next 10 years due to the drug marketed since 1994. Claimants are demanding company-paid monitoring for such complications.

Since the study's release, medical researchers have concluded that hormone replacement pills should not be taken for any reason other than as brief treatment to help women through the worst symptoms of menopause. Wyeth is challenging the validity and the results of the 2002 study and is asserting the study does not support the women's request for diagnostic work ranging from periodic physical examinations and biopsies to MRI and CT scans.

Wyeth is asking the court to reverse its decision to grant class action status to the lawsuits.

Prempro Hormone Relpacment Therapy Side Effects and Health Risks
Women have used hormone replacement therapy for nearly half a century. One of the most popular hormone replacement therapies is the Prempro pill, manufactured by Wyeth Pharmaceuticals, and used by an estimated six million women. Unfortunately, the pill has been linked to a number of serious health concerns including higher risk of breast cancer, heart attack and cardiac arrest, stroke and pulmonary embolism (blood clots).

A long-term study by the National Heart, Lung, and Blood Institute (NHLBI), consisting of more than 16,000 women between the ages of 50 and 79, discovered that women who were given Prempro were much more likely to develop serious health problems compared to women in the placebo group. The study revealed a:

• 22% increase in Cardiovascular disease
• 26% increase in breast cancer
• 29% increase in heart attacks
• 41% increase in strokes
• 113% increase in blood clots in the lungs

The study was initially planned to last eight years, but the side effects were so severe that the Data and Safety Monitoring Board halted the study in May 2002, after only 5 years, citing serious health risks to study participants.

A June 2003 analysis of data from the Women's Health Initiative found that even short-term use of Prempro increases the risk of breast cancer and may make detection of the cancer more difficult. The report found that just one to three years of Prempro use can lead to abnormal mammograms in one in 25 women and raise the risk of breast cancer 24 percent within five years. Additionally, recent studies also indicate that women who take hormones for years may more than double their risk of Alzheimer's or other types of dementia.

Several claims have been made against the manufacturer relating to use of the prescription hormone replacement therapy (HRT) drug Prempro.