Drug Warnings: Prempro Side Effects and Risks
Prempro, Wyeth’s best-selling drug for hormone replacement therapy (HRT), has been marketed as a safer alternative to estrogen therapy for postmenopausal women. Prempro is prescribed to treat symptoms of menopause such as hot flashes and a reduction in bone density leading to fractures, particularly fractures of the hip.
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In January 2003 the FDA (Federal Food and Drug Administration) required a black box warning for Prempro. This action was based on the results of the Women’s Health Initiative (WHI) study conducted by the National Institute of Health (NIH). See Prempro Information and Warnings for more information on Prempro studies. The black box warning is the FDA’s highest level of warning for a drug that is allowed to remain on the market.
The 2003 labeling change required Wyeth, the manufacturer of Prempro, to include information from the WHI study, which reported increased risks of myocardial infarction (heart attack), stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women who took Prempro for 5 years. The new label also included the warning that Prempro should be prescribed at the lowest effective dose for the shortest duration that was consistent with treatment goals.
Check out the following articles for more information about Prempro, filing a Prempro lawsuit and finding a Prempro attorney:
Suffered harm from Prempro? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights. |