July 2002 was a life-altering month for the millions of women using hormone replacement therapy (HRT). That month, the National Institutes of Health shut down a massive Women’s Health Initiative (WHI) study of the effects of HRT in menopausal women. The reason: After less than a year on PremPro, the only estrogen-progestin combination drug tested in the study, a large percentage of the otherwise healthy 16,000 U.S. women showed an increased risk of breast cancer, heart disease, blood clots and stroke. Specifically, the study found the following PremPro side effects:

• 26 percent increase in breast cancer.

• 41 percent increase in strokes.

• 29 percent increase in heart attacks.

• 100 percent increase of blood clots in legs and lungs.

• Increased risk of ovarian and endometrial cancer.

Study results showed that for every 10,000 healthy, postmenopausal women taking PremPro for a year, there would be eight additional cases of breast cancer, seven heart attacks, eight strokes and eight blood clots in the lungs. At first glance, those numbers don’t seem significant. However, in 2002, more than 6 million women were taking PremPro. Statistically, that translates into:

• 480,000 additional breast cancer cases.

• 420,000 more heart attacks.

• 480,000 more strokes.

• 480,000 more blood clot cases.

Other studies released since that time have substantiated WHI’s findings. In fall 2003, researchers found the WHI data also suggested that women who take combined HRT continuously may face a higher risk of the much rarer ovarian cancer, as well as increased likelihood of needing procedures used to diagnose endometrial cancer. The results appeared in the October 1, 2003, issue of The Journal of the American Medical Association.

In response to the PremPro controversy, Wyeth, maker of PremPro, has issued new guidelines that caution against its long-term use and has reduced the drug’s recommended dosage by half. Unfortunately, it may be too little too late for the many women who have suffered adverse effects. Unsafe prescription drugs have been marketed without comprehensive testing or have inadequate warning labels. Even more alarming is the fact that many of the tests required by the Food and Drug Administration (which regulates the prescription drug market) may be funded by the drug manufacturer.

In addition to the potentially life-threatening PremPro risks, there is also a long list of other side effects that affect women taking PremPro, Femhrt and other combined HRT. (HRT means any combination of the hormones estrogen and progestin.) These side effects include:

Multiple medical organizations have issued statements urging women to avoid using combined estrogen-progestin therapy if at all possible. Unless women are suffering severe menopausal symptoms that have not responded to any other form of treatment, they should first try alternative therapies, such as exercise, relaxation techniques and vitamin E supplements. If HRT use cannot be avoided, the U.S. Food and Drug Administration in 2003 stated the therapy should only be used in the lowest possible doses for the shortest possible time.

If you have suffered harmful effects from Prempro such as breast cancer, ovarian cancer, stroke or heart attack, you may be entitled to file a legal claim against the drugs maker for negligence in product labeling and marketing. Learn More about your Legal Rights.