FDA to Reevaluate Prempro Risks
August 15, 2002
The U.S Food and Drug Administration (FDA) announced this week that it will reevaluate the safety of the controversial hormone replacement medication Prempro. The reassessment, to be conducted by the agency's Center for Drug Evaluation and Research, will determine if the drug's risks (Prempro has been linked to stroke, heart disease, breast cancer and blood clots) outweigh its benefits. The Department of Health and Human Services plans to hold a public forum this fall in an effort to gather data on the estrogen-progestin combination.
In July 2002, The National Institute of Health (NIH) stopped a 16,608-woman study on the benefits of hormone replacement therapy three years early, concluding that hormones such as estrogen and progestin place women who still have their uterus at risk of developing invasive breast cancer. Women involved in the trial had been taking Prempro or a placebo for five years before the study was halted. FDA officials say the reevaluation may have a significant impact on the future of hormone replacement therapy.
-- Article Courtesy of InjuryBoard.com
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