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First Hormone Replacement Therapy Warning Signs In 1990, HRT drug manufacturer, Wyeth, contacted the Food and Drug Administration requesting a label change that would indicate that HRT helps protect against heart disease. The FDA denied the request stating that the drug company must produce more data to support their claims. Therefore, Wyeth conducted a randomized controlled HRT study, which found that instead of protecting against heart disease, HRT drugs increased the risk of heart attacks and other cardiovascular complications. Women’s Health Initiative (WHI) Study Around the same time that Wyeth began conducting its HRT clinical trials, the National Institute of Health launched the Women’s Health Initiative study, which was aimed at determining the risks and benefits associated with hormone replacement therapy drugs. The WHI study evaluated more than 16,000 women who were taking estrogen replacement therapy or a combination of estrogen and progestin therapy. The trial began in 1993 and was intended to continue until 2005. However, the hormone replacement therapy side effects were so alarming and occurred at such a frequent rate that the study was halted in 2002. This clinical trial was the only large study evaluating the effects of HRT and found that the drugs significantly increased the risk of:
Women involved in the study were advised to immediately discontinue the use of HRT drugs and look for hormone replacement therapy alternatives to alleviate their symptoms of menopause. Your Legal Rights |
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