For decades, women were advised to take hormone therapy to avoid the discomforts of menopause and be protected against many chronic diseases common in the post-menopause years. In addition to decreasing hot flashes and other signs of menopause, replacing the natural hormones lost in menopause was thought to be a good way of protecting women against heart disease, osteoporosis, memory loss, wrinkles, and mood swings. To gain these assumed benefits, women were advised to begin taking hormones before menopause, and to continue taking them for many years, or even decades post-menopause, in order to have the best quality of life and avoid serious illness.

Doctors usually prescribed a combination of synthetic estrogen and progestin to replace falling levels of the two hormones, a natural condition of menopause. Women who had a hysterectomy only needed to take estrogen. The latest studies, which are considered definitive, have clearly shown that the risks of taking these hormones far outweigh the benefits. Women taking Prempro, the combination hormone pill used in the aborted clinical trials, were far more likely to develop breast cancer, stroke, blood clots, and Alzheimer’s, and just as likely to develop heart attacks, compared to women taking a placebo. Women taking estrogen alone (Premarin), had increased risks of blood clots and stroke.

The first shift in thinking about hormone therapy was a name change. Hormone replacement therapy was changed to hormone therapy to underscore that hormones don’t necessarily need to be replaced in menopause. Doctors now tend to prescribe hormones only in cases of severe menopause
symptoms, when discomforts interfere with the quality of life.

New Guidelines from the FDA

The FDA has issued guidelines to advise physicians and drug companies with regard to patient education. If the guidance you received differs from this, you should contact your physician to discuss these recommendations and question whether you should change anything you are doing, including stopping taking Prempro or other hormone therapy for menopause.

Listed below are the new FDA recommendations:

• Hormone therapy is effective for short-term relief of moderate to severe menopausal symptoms such as hot flashes;
• Hormone therapy can be effective for moderate to severe vulvar and vaginal atrophy, but topical agents should be tried first;
• Hormone therapy is effective for reducing the risk of osteoporosis, but it should only be considered for women at major risk for osteoporosis who can’t take other medications to prevent osteoporosis.
• Hormone therapy should only be taken at the lowest possible dose and for the shortest possible time to achieve a therapeutic benefit.

The Bottom Line

Hormone therapy is not a miracle drug to restore your youth, protect your health, and stave off the diseases of old age. In fact, it can have the opposite effect and stack the deck so you are more likely to experience breast cancer, stroke, Alzheimer’s disease, dementia and blood clots. It does have some limited benefits for treating short-term symptoms of menopause such as hot flashes and insomnia. If you have symptoms of menopause which you find hard to live with, discuss options with your physician. Even small amounts of hormones have powerful effects on the body. Take them with caution, if at all.

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.

• Name: Prempro Hormone Replacement Therapy
• Generic Conjugated Estrogen and Conjugated Medroxyprogesterone Acetate
• Manufacturer: Wyeth Pharmaceuticals
• Date Approved: November 1995
• Status: Prescription Only
• Approved Uses: Menopausal Symptoms
• Off-Label Use: Heart Disease Prevention
• Side Effects: Heart Disease, Breast Cancer, Ovarian Cancer, Stroke, Blood Clots, Dementia

What is Prempro?

Prempro is a prescription medication approved as a hormone replacement therapy for menopausal symptoms in women who still have their uterus. The drug contains a mixture of natural estrogen hormones as well as a progestin, a synthetic form or progesterone, a natural hormone. Pempro comes in tablet form and is taken once a day. Possible side effects of the drug, according to the manufacturer, Wyeth, are headaches, breast pain, and back pain.

Officially, Prempro is approved for the following uses:

• treating moderate to severe hot flashes due to menopause
• treating moderate to severe itching, burning, or dryness in and around the vagina due to menopause
• Preventing heart attacks in postmenopausal women

Prempro is only approved for women who still have a uterus (have not had a hysterectomy).

Treatment Regimen

Prempro, also known as estrogen/conjugated medroxyprogesterone acetate, was approved by the U.S. Food and Drug Administration (FDA) in November 1995, as a drug to relieve menopause symptoms and osteoporosis. It is a combination of two hormones–estrogen and progestin, and is used only by menopausal women who have not had hysterectomies. Prempro was the first approved medication for hormone replacement therapy (HRT), and is still one of the most common HRTs prescribed by physicians. In 2003, it was estimated that more than 10 million postmenopausal women in the U.S. took estrogen or the combination of estrogen and progestin products to treat symptoms of menopause. The typical treatment consists of one tablet (pill) containing 0.625 mg of estrogen and 2.5 mg of progestin daily.

Prempro, a drug containing a combination of two hormones, estrogen and progestin, was supposed to relieve menopause symptoms like hot flashes, night sweats and mood swings. Many health leaders and women’s advocacy groups lobbied for many years for the government to undertake a clinical trial to test the downsides of older women taking hormone replacement drugs. In 1997, the National Institutes of Health undertook a study to investigate the link between hormone replacement therapy and cancer as well as other serious chronic diseases in older women.

Same Drug, Different Marketing

Breast cancer is the most commonly diagnosed cancer among women in the United States, according to the Centers for Disease Control. Rates have been decreasing in recent years with the sharpest decline seen in 2002 and 2003 — a 14 percent decline in women 50 to 69, probably due to the dramatic decrease in the numbers of women continuing to take Prempro after the end of the Women’s Health Initiative. To stay viable in the market and respond to scientists’ criticism of the company’s marketing practices, Wyeth has re-formulated the drug and promoted smaller doses taken for shorter periods of time. Sales of the hormone drug dropped to about $900 million in 2006 from $2 billion in 2001, the year before the Prempro trial was stopped. Before that, hormone replacement therapy was routinely prescribed for all women reaching menopause not only to relieve the unpleasant symptoms of menopause but to avert heart disease and brittle bones, and keep women’s skin soft and supple in the post-menopause years, off-label benefits promoted by Wyeth but largely unproven.

In a large clinical trial sponsored by the government, Prempro was shown to cause excessive numbers of cases of breast cancer, heart attacks, strokes, dementia, and other health crises in women. Because of these dire and unexpected outcomes, the clinical trial was stopped years ahead of schedule, and in 2003, a year later, the FDA required Prempro to carry a black-box warning about serious side effects, the most severe warning the FDA can impose short of removing a drug from the market.

In the government’s halted clinical trial of hormone therapy for menopause, one out of four women taking Prempro (26%) developed breast cancer, one out of three (29%) heart attacks, four out of 10 (41%) strokes, and double the number of Prempro users experienced blood clots, dementia, lupus or urinary incontinence, compared to women in the control group. Is it any wonder that there are more than 10,000 Prempro lawsuits on file in state and federal courts, currently?

The first of these lawsuits went to trial in the summer and fall of 2006 and 2007. Three out of four cases were settled in the plaintiff’s favor with cash awards. Plaintiffs in these actions successfully argued that Wyeth misled them and their doctors using deceptive advertising techniques, persuading them that the drug would keep them looking and feeling youthful, a totally unsubstantiated claim, and protect them against heart disease, another false claim. Wyeth failed to warn physicians and patients about Prempro’s side effects and health risks, although several previous studies had shown Prempro to be a factor in breast cancer. But it was not until 1997, when the Women’s Health Initiative trial was launched, that definitive evidence of a positive link to breast cancer and other serious chronic diseases were firmly established.

Deadly Deceptions

Lawyers for women suing Wyeth say the company never performed any long-term tests of its hormone replacement drugs, Prempro and Premarin (estrogen only). Instead, the company urged doctors to put their patients on the drugs for life, in effect making the patients the unwitting test subjects in a long-term observational study of drug effectiveness and side effects. Unfortunately, this secret trial was not only unscientific, but illegal without the consent of physicians and their patients.

Wyeth had made the case in court that because the drug (Prempro) had been approved by the FDA, product liability suits are pre-empted or barred, because federal law gives the FDA the exclusive right to determine whether a drug’s label, or detailed package insert, contains adequate warnings about health risks.

A Superior Court judge in New Jersey (June 27, 2007) issued a pre-trial ruling that being approved by the FDA does not protect companies from being sued. The FDA regulations on label warnings are a floor, not a ceiling. Drug companies can strengthen warnings and add new ones. In another pre-trial ruling in the same case, the judge ruled that a doctor prescribing a drug does not preclude a patient from suing over alleged harm. In New Jersey, in addition to product liability suits, Prempro plaintiffs can also sue under New Jersey’s Consumer Fraud Act.

As a result of intense lobbying by consumer and physician groups urging greater FDA monitoring of drugs after-market, the Congress passed a law in 2007 to expand FDA’s authority.

As of July, 2008, about 250 Prempro lawsuits were pending in New Jersey and about 10,000 had been filed nationwide. The outcome of early drug trials are beginning to be known and the manufacturer, Wyeth, has settled several lawsuits before they went to trial, indicating that the company already sees the handwriting on the wall.

If you have questions or think you might have a case against Prempro, fill in one of the brief questionnaires on this website and we will ask an experenced and knowledgeable attorney to respond with a free consultation.