Learn More About Prempro Lawsuits
If your doctor failed to warn you of the health risks associated with taking Prempro, a medical malpractice lawyer or personal injury lawyer can advise you on your legal rights. A personal injury lawyer can help you pursue a lawsuit and get the financial retribution you deserve for your injuries.
Prempro is a hormone replacement therapy (HRT), approved in 1995, to aid women experiencing discomforts during menopause. In addition to the replacement of lost female hormones, the drug also protects against endometrial cancer and bone density loss.
Manufactured by Wyeth, Prempro is a combination of premarin (a synthetic estrogen) and progestin (a type of synthetic progesterone).
If taken daily, in pill form, it is highly effective at treating hot flashes, vaginal dryness, sleep disturbances and other menopausal symptoms.
However, because of its known health risks, the Food and Drug Administration (FDA) required Wyeth to post a black box warning on the label. This warning, based on results of a Women’s Health Initiative
cancer study aborted in 2002, has contributed to a 70% decrease in the use of hormone products since then.
During the mid-nineties, the Women’s Health Initiative (WHI) launched a nationwide clinical trial involving 161,808 post menopausal women in general good health, ranging in age from 50 to 79.
Among the issues being tested was the effect of hormone replacement therapy
, with estrogen and progestin/progesterone, on post menopausal women with a uterus.
A separate part of the trial involved an estrogen-only study of women without a uterus. Women taking estrogen-only have an increased risk of endometrial cancer, which is cancer of the uterine lining.
Since progesterone counteracts this risk, women who have not undergone a hysterectomy are advised to take the combined estrogen/progesterone HRT regimen.
In both trials, women were randomly assigned to either the HRT medication or to a placebo. Although the trials have now ended, the women who participated will continue to be monitored until 2010.
The original trial – which was supposed to conclude in 2005 – was intended to settle the debate on HRT and its effect on bone density, heart disease, breast cancer and colorectal cancer. However, alarming mid-trial results caused researchers at the National Heart, Lung, and Blood Institute (NHLBI) to halt the study in July, 2002 – 3 years before it was due to end.
Here’s why the plug was pulled: The HRT study combining estrogen and progesterone/progestin showed an increase in breast cancer by 26%, heart attack by 29%, stroke by 41%, cardiovascular disease by 22%, and double the number of blood clots.
On the positive side, however, the combined regimen also showed a 37% reduction in colorectal cancer, 33% reduction in hip fractures, 24% reduction in total fractures and no difference in mortality rates.
Despite these results, about 6 million American women still use Prempro daily – Wyeth continues to market it, and physicians continue to prescribe it. Prempro is currently the top-selling HRT drug.
Women who took part in the estrogen-alone arm of the study did not experience any noticeable health risks and that phase of the study was allowed to continue. However, after release of the HRT findings, the FDA required Wyeth to change Prempro's labeling to include information from the WHI study.
In July of 2005 the United Nations reclassified Prempro from “possible carcinogenic” to “carcinogenic.”
Despite Prempro’s many HRT benefits, it was determined that a woman’s increased risk for so many life-threatening problems would outweigh any positive benefits derived from its use. Consequently, women who opt for HRT during menopause are being advised to take the lowest dose possible for the shortest amount of time.
While Wyeth has been hit with thousands of lawsuits linking Prempro to breast cancer and other illnesses, it has not taken the drug off the market, and sales remain high (over $1 billion dollars in 2006 and 2007).
But the WHI study may not be the last word on HRT; new findings could present the groundwork for future legal challenges by Wyeth against upcoming lawsuits.
In September, 2008, Danish researchers reported that women who take hormone replacement therapy to treat menopause symptoms do NOT have a higher than usual risk of heart attack, especially if they use a cream or skin patch or take "cyclic" hormone combinations. This study, published in the European Heart Journal, claims that it is not HRT that raises the risk of heart attacks in women, but the way it is taken.
This study – which looked at 698,000 Danish women aged 51 to 69 – said that it found no increased risk of heart attack with the current hormone therapy compared with women who never used hormone therapy. The type or dosage of estrogen or progesterone did not matter, they found. Patches or gels lowered the risk of heart attack by 38% to 44%.
Read Abouts The Risks Associated With Prempro
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