Prempro Lawsuit and Litigation

Researchers at the University of Illinois at Chicago are investigating whether hormone therapy and two alternative herbal products can lessen memory and other cognitive problems experienced by menopausal women.

Up to 112 women will be recruited to participate in the study. They will be randomly assigned to one of four groups taking black cohosh, red clover, Prempro (a combined estrogen and progestin hormone replacement drug) or a placebo. Health effects will be closely monitored over about 14 clinic visits.

A hearing began Wednesday to determine whether millions of women who took the hormone-replacement drug Prempro can be certified in a single class-action lawsuit against the drug�s manufacturer. In the lawsuit, women who have used Prempro say the manufacturer Madison, N. J.-based Wyeth falsely advertised the benefits and failed to acknowledge the risks of the drug, usually prescribed to treat menopause symptoms.

Conjugated estrogens increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with conjugated estrogens lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together with the estrogen. Visit your doctor regularly and report any unusual vaginal bleeding right away.

The Women's Health Initiative (WHI) study found an increased risk of breast cancer, heart disease, nonfatal heart attacks, and blood clots in women taking estrogen and medroxyprogesterone combinations long-term. You should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking a conjugated estrogen and medroxyprogesterone combination long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.

Higher Risk of Cancer, Heart Attack, Stroke, Blood Clots: Researchers have halted a government-operated study of the popular hormone pill Prempro, taken by millions of women. Use of the pill has been found to increase the risk of invasive breast cancer, coronary heart disease, strokes, and blood clots in the lungs. It is believed that the action will create a serious dilemma for millions of women. The question for many women and their doctors is how to approach medical decisions concerning Menopause - that passage that involves every part of you-your mind, body and spirit. Natural changes such as hot flashes, osteoporosis and dryness have for half a century been treated through various methods including hormone replacement therapy (HRT). However, in July 2002, warnings were issued concerning Prempro - the popular product used by six million women.

http://www.irishhealth.com/index.html?src=ez&link=71710&level=4&id=7634

Breast cancer is one of the most commonly diagnosed cancers among women in western countries, including Ireland. However while some of the disease's risk factors are known, such as genetics and age, many remain unexplained. Now a new study indicates that long-term exposure to passive smoking may have to be added to the list of risk factors.

This risk was even more marked among non-smokers who had not yet gone through the menopause. In fact, among these women, breast cancer risk increased by 68%.

Q. I have been on hormone-replacement therapy (HRT) since my 40s. Over the past few years, I have tried to get off the hormones a number of times, but the debilitating symptoms have driven me back to them. Do you have any recommendations for alternatives?

The Charlotte Observer, Mon, 06 Jun 2005 0:12 AM PDT

Under the guidance of the federal government, the National Heart, Lung and Blood Institute (NHLBI) launched a study to determine the long term effects of Prempro, a hormone replacement therapy drug. The study, originally planned to last eight years, was abruptly halted after five years when researchers determined the side effects were so severe they could not continue to give patients the drug.

In medicine today, there�s another reason for women not to miss regular mammograms. This is especially important for women who are taking hormone replacement therapy. Researchers at the University of Melbourne in Australia found an increased chance that cancer may be missed among women on HRT. That may be because some of their breast tissue is more dense, making the cancer more difficult to find. The study is in the journal Cancer Epidemiology. http://cbs2chicago.com/ <

The Link Between Combination Hormone Replacement Therapy and Breast Cancer In order to test the effect of HRT on the prevention of coronary heart disease, as well as osteoporosis, hormone replacement therapies were made part of the Women's Health Initiative (WHI). The WHI is a massive study of more than 167,000 women nationwide, designed to investigate various different aspects of women's' health over a 15-year span. It is considered the "gold standard" in random clinical testing. 16,000 women participated in the combination hormone therapy portion of the trials, taking both and Provera or a combination drug like Prempro. This portion of the trial was designed to last eight years.

Premarin is an estrogen replacement drug. The tablets are used to reduce moderate to severe symptoms of menopause, including feelings of warmth in the face, neck, and chest, and the sudden intense episodes of heat and sweating known as "hot flashes." Cenestin tablets, containing a synthetic form of conjugated estrogens, may also be prescribed for these symptoms. In addition to the symptoms of menopause, Premarin tablets are prescribed for teenagers who fail to mature at the usual rate, and to relieve the symptoms of certain types of cancer, including some forms of breast and prostate cancer.

British Medical Journal, Thu, 09 Jun 2005 3:59 PM PDT HRT increases risk of stress and urge urinary incontinence Question Can hormone replacement therapy (HRT) decrease the risk of urinary incontinence in postmenopausal women? Synopsis As predicted, more spin-off studies are coming from the women's health initiative multicenter clinical trial of hormone therapy in postmenopausal women.

Experts in Britain and other European countries yesterday said curbs had been wrongly imposed on HRT drugs following 'flawed and misleading' research. Studies showing women taking the therapy live longer than women not on the drugs and are more likely to survive breast cancer have been ignored, they said. Dr John Stevenson, chairman of the Women's Health Concern charity, said there was a backlash against limits put on the use of HRT by regulators. He said: 'Women are being denied HRT and suffering the consequences of menopausal symptoms because of seriously flawed and misleading research.' He was speaking at a symposium of international HRT experts at Surrey University.

No Lump Required for serious breast cancer known as Inflamatory Breast Cancer I hope that you never have a need for this information, but, reading about the experience of others, could save your life. Did you know that one of approximately 11,000 women nationwide that do get this most aggressive form of breast cancer. It is called Inflammatory Breast Cancer. The scariest part is that there is usually no lump!

When diagnosed with non-invasive ductal carcinoma in situ, usually a wide excision, followed by 8 weeks of radiation is the course of treatment. This is a non-invasive cancer that is contained in the milk ducts. It is often considered to be at Stage 0.

-> Bioidentical Hormones
"Bioidentical hormones" is a term that means different things to different people. To scientists and healthcare providers, it means hormones identical to those produced by the human ovary. For estrogen, it's 17-beta-estradiol. For progestogen (needed for women with a uterus who use estrogen to protect the uterus), it's progesterone. There are several FDA-approved products containing these two hormones. However, the public (and a few healthcare providers) typically use the term to mean custom-compounded hormones - drugs that are made by a compounding pharmacist from a physician's prescription. These compounded products have not undergone rigorous clinical trials and must be recognized as experimental therapies, not tested for effectiveness or safety. Insurance programs typically do not reimburse for these experimental therapies.

The term 'bioidentical' is almost as ingenious as the term 'natural' when it comes to marketing a product; both terms appeal to consumers' aversion to 'artificial' ingredients, and they suggest that what you are getting can have no adverse effects. But I and many of the physicians and researchers who have looked at studies or tested what's in these so-called 'nature-made' products disagree.

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