Prempro (conjugated estrogens/medroxyprogesterone acetate tablets) is a hormone therapy that is used to help manage moderate to severe symptoms of menopause– including hot flashes, night sweats, and vaginal symptoms. Prempro contains estrogens and a progestin and therefore is to be used only by women with a uterus who are undergoing natural menopause.
Prempro is prescribed for menopausal women to reduce moderate to severe hot flashes, to treat moderate to severe dryness, itching, and burning in and around the vagina, and to help reduce the chances of osteoporosis (thin, weak bones).
In 2003, the FDA approved Prempro for the treatment of moderate to severe symptoms of hot flashes and night sweats associated with menopause, and to treat moderate to severe symptoms of vulvar and vaginal atrophy.
The most commonly reported side effects while taking Prempro include vaginal discomfort or pain, breast pain, vaginitis, and itching. Dizziness, lightheadedness, headache, stomach upset, bloating, irritability, changes in sleep patterns, fatigue, nausea, weight changes, and an increased/decreased interest in sex may also occur.
In 2003, the FDA issued a black box warning to be included on the labeling of Prempro that states estrogens and estrogen plus progestin therapies should not be used for the prevention of cardiovascular disease. Specifically, it states that because the Women’s Health Initiative (WHI) study reported an increased risk of myocardial infarction, stroke, invasive breast cancer, and venous thromboembolism (VTE), estrogens and estrogens plus progestin therapies should be prescribed for the shortest duration consistent with treatment goals. Two-drug combination hormone replacement therapy can infrequently cause cancer of the breast, heart disease/heart attack, stroke, dementia, and blood clots in the lungs (pulmonary embolism) or legs. Estrogens may also increase the risk of ovarian cancer.
Prempro is contraindicated in patients who have a history of abnormal vaginal bleeding, cancer; e.g., of the breast or ovary, blood clots, active/recent stroke or heart attack, or liver disease.
Is Prempro recommended for menopausal women only experiencing vaginal discomfort?
If you are only being treated for vaginal menopause symptoms, products applied locally such as vaginal creams, tablets, or rings should be considered before products taken by mouth or absorbed through the skin. There are several medications that are safe and effective to treat these symptoms. These medicines should be considered for use before estrogen/progestin HRT therapy, such as Prempro, is administered.
Who should NOT take Prempro?
Patients should not use Prempro if they have a circulation, bleeding, or blood-clotting disorder, liver disease, abnormal vaginal bleeding, or any type of breast, uterine, or hormone-dependent cancer. Do not take Prempro if you think you are, or plan on becoming, pregnant.
What are the warning signs of a bad reaction to Prempro?
Warning symptoms include mental/mood changes; e.g., severe depression, memory loss, calf pain/swelling, sudden severe headache, chest pain, trouble breathing, one-sided weakness, slurred speech, vision changes, swelling of hands and feet, changes in vaginal bleeding; e.g., spotting, breakthrough bleeding or prolonged bleeding, unusual vaginal discharge/itching/odor, and yellowing of the eyes or skin (jaundice).
What should I tell my doctor before taking Prempro?
Before taking Prempro, it is important to tell your doctor if you have a family medical history of breast lumps and cancer, asthma, diabetes, seizures, migraine headaches, heart disease; e.g., high blood pressure, heart attacks, congestive heart failure, kidney disease, low thyroid hormone (hypothyroidism), abnormal calcium level in the blood, depression, high blood pressure during pregnancy (toxemia), yellowing of eyes and skin during pregnancy or with past estrogen use, womb problems; e.g., uterine fibroids, endometriosis, cholesterol or lipid problems, gallbladder disease, excessive weight gain, or certain blood disorders (porphyria).
Can I file a lawsuit if I have suffered damages from taking Prempro?
Possibly. 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.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:
- Past and future medical expenses
- Past and future pain and suffering
- Lost wages
- Loss of future earning capacity
- Emotional distress
If you or a loved one has experienced any health problems while taking Prempro, you should contact your doctor immediately. You may also wish to contact an experienced Prempro lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.