Prempro FAQS

by Luise Light on August 1, 2008

What is Prempro?

Prempro, formerly known as Hormone Replacement Therapy (HRT), is a medication prescribed for hormone treatment of menopausal women. It is given to prevent hot flashes and other uncomfortable symptoms of menopause that are caused by falling and erratic circulating levels of the hormones estrogen and progesterone. Prempro, which combines synthetic estrogen and progestin, is designed to artificially boost circulating levels of the two hormones.

Who Should Not Take Prempro?

Do not take Prempro if you have or have had a heart condition, high blood pressure, cancer but especially, breast, ovarian, uterine, or other hormone-dependent cancers, a bleeding or blood-clotting disorder, liver disease, abnormal vaginal bleeding, or if you are postmenopausal and past the discomforts of menopause. Do not take Premprin to prevent heart disease or osteoporosis. It is only approved in the USA for the short-term treatment of menopause symptoms.

What Should I Know About Prempro?

In 2002, the Women’s Health Initiative (WHI) of the National Institutes of Health, was halted prematurely when researchers found that women in the treatment arm of the study taking HRT ( Prempro) had more cases of breast cancer and strokes, compared to women in the control group who did not take HRT. The WHI findings were later confirmed in a second, even larger, British study, known as the Million Women Study.

As a result of these findings, warnings were published in medical journals and in announcements from the FDA, cautioning that women with normal menopause should only take prescribed hormone treatments at the lowest feasible doses, and for the shortest possible time, if at all. For health problems associated with menopause such as osteoporosis (a small percentage of postmenopausal women are at risk of severe bone loss), other lifestyle changes and/or medications are recommended. Hormone therapy is for short-term relief (often one or two years, usually less than five) from symptoms of menopause.

How Many Postmenopausal Women Are Taking Prempro?

Wyeth, the manufacturer, estimates that 10 million postmenopausal women are taking the medication, or some other form of estrogen, either in combination with progestin (synthetic progesterone) or alone.

What Are the Possible Side Effects of Prempro?

Wyeth reports these side effects: Irregular or abnormal vaginal bleeding, including spotting, breakthrough bleeding, prolonged or heavier vaginal bleeding, or bleeding completely stopped after 10 months on the pill, vaginal itching or irritation, thick white vaginal discharge, sharp chest or lower leg (calf) pain, breast lumps or tenderness, severe headaches, shortness of breath, coughing up blood, severe stomach pain or swelling, mild dizziness, nausea and fluid retention, memory loss, dementia.

What Is the Legal Definition of Pharmaceutical Negligence, and Is Prempro an Example?

Legal definitions vary from state to state, but generally, it means that a drug company failed to act within an appropriate standard of care by causing injury or death to a consumer who used their product(s). This could be the result of a drug that was not tested adequately or due to failure to provide appropriate warnings to physicians prescribing the drug to patients.

Is There a Time Limit on When a Lawsuit Can Be Brought Against a Drug Manufacturer?

Yes. Each state and the federal government have very different statutes of limitations on the time period when a malpractice suit can be pursued. For that reason it is best not to wait too long to look into whether you have a viable case. The referral form on the pages of this website will provide an opportunity to query an attorney, free of charge, who is experienced in these matters. Simply fill out the form and we will initiate a contact for you.

Now that you’ve begun your research on Prempro, you might want to explore the need for safer drugs and better prescribing practices, next.

Previous post: FDA Gets More Clout

Next post: Hormone Therapy Today