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The Food and Drug Administration approved Prempro in 1995 as a hormone-replacement therapy. Side effects became a concern after studies linked Prempro to a number of health problems. A major study of the long-term use of Prempro found that the drug significantly increases the risk of breast cancer, heart attack, blood clotting and stroke. In addition, Prempro has been linked to ovarian cancer, lupus, asthma and pulmonary embolisms. Studies found that Prempro caused a 26 percent increase in breast cancer, a 29 percent increase in heart attacks, a 41 percent increase in strokes and a 100 percent increase in blood clotting in the legs and lungs.

FDA Approves Lower Dosage

In 2003, the FDA approved a lower dosage of Prempro to treat symptoms of menopause. Within the approval, the FDA advised women to speak to their doctors when considering hormone-replacement therapy and warned that because of the risks involved, the lowest dose should be used for the shortest duration needed. Read the full FDA approval for lower dosage of Prempro.

To learn more about legal claims relating to Prempro, consult an attorney who practices in the area of drugs and medical devices.