Approved by the FDA in 2003, Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) is an estrogen plus progestin therapy that is used to treat moderate to severe symptoms of menopause–including hot flashes, night sweats, and vaginal symptoms, and to help reduce the chances of osteoporosis. Prempro is to be used only by women with a uterus who are undergoing natural menopause. The most commonly reported side effects associated with Prempro include vaginal discomfort and pain, breast pain, and vaginitis.
However, the same year in which it was approved (2003), the FDA issued a black box warning to be included on the labeling of Prempro that states there is an increased risk of myocardial infarction, stroke, invasive breast cancer, and venous thromboembolism (VTE) when taking estrogen plus progestin therapies, and the drug should be prescribed for the shortest duration consistent with treatment goals. Further, the use of Prempro has been linked to the development of heart disease and dementia. Prempro may also increase the risk of ovarian cancer and should never be taken by women who have a history of abnormal vaginal bleeding or liver disease.
While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as "product liability."
If you or a loved one has experienced any health problems from using Prempro, including myocardial infarction, stroke, breast cancer, and venous thromboembolism (VTE), you do have legal rights and a qualified Prempro lawyer, as provided on this site, is standing by to help you with your case. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay. Please call today to arrange for an initial consultation to discuss your specific legal claim and the litigation options available to you.
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