At about the same time pharmaceutical giant Merck will be entering its second year of trials in the massive Vioxx litigation consisting of some 12,000 cases, Wyeth, another major drugmaker, will be starting the first trial involving its menopausal treatment, Prempro.
It is estimated that there are over 4,000 Prempro lawsuits pending and only the overwhelming number of Vioxx actions makes that figure look small. After all, everything is relative.
Nonetheless, the Prempro litigation promises to be quite expensive for Wyeth, which was known as American Home Products when it agreed to settle litigation arising from its diet “cocktail” fen-phen for $3.75 billion in 1999.
The first Prempro trial is scheduled for July 31 in U.S. District Court in Little Rock, Arkansas. Claims involving Prempro are spread out across the U.S. and involve a host of alleged injuries.
Prempro (Conjugated estrogens/Medroxyprogesterone acetate tablets), a hormone replacement therapy (HRT) used to treat symptoms of menopause, has been linked to serious side effects including breast cancer, ovarian cancer, gallbladder cancer, lupus, scleroderma, stroke, blood clots, severe asthma, and pulmonary embolisms.
At its height, over 22 million prescriptions were written for Prempro each year to treat post-menopausal hot flashes and other menopause symptoms.
A major HRT study, however, found that long-term use of Prempro is dangerous and significantly increases the risk of stroke, blood clots, heart attacks and breast cancer.
These results were so disturbing that the National Institute of Health (NIH) prematurely terminated the study out of concern for the study’s participants.
As a result of the study it is now suggested that many of the women who use Prempro and other estrogen and progestin combinations should stop doing so and discuss possible alternatives with their doctors.
The current evidence appears to indicate that Prempro and other estrogen progestin combinations can cause harm to otherwise healthy women. The study found that women who were given Prempro were more likely to develop serious problems than women in the placebo group. Those findings included: a 26% increase in breast cancer; a 41% increase in strokes; a 100% increase in blood clots; and a 22% increase in incidents of cardiovascular disease.
Prempro was introduced in 1995 and remains there despite the study results, the claims relating to its side effects, and the 4,000-plus lawsuits. Wyeth has taken the position that Prempro is safe and has not caused any woman to develop breast cancer. As in the case of other allegedly dangerous prescription drugs, Wyeth points to Prempro’s approval by the FDA as proof that it is safe.
Wyeth, as well as some experts and financial analysts, do not believe the study results were indicative of any definitive finding that proves Prempro causes breast cancer.