PremPro was introduced to the market to help ease the side effects commonly associated with menopause, however, because of the serious and harmful risks associated with the hormone replacement therapy a study was halted by the National Institute of Health (NIH). Women must be aware of the side effects of this drug in order to protect themselves from breast cancer developing.
As women age they develop menopausal symptoms that may cause serious discomfort and irregularities among their daily lives. Technology has assisted in the development of many treatments and pharmaceuticals to decrease the menopause side effects, including PremPro, which is a combined hormone replacement therapy (CHRT).
In July 2002, the National Institute of Health (NIH) halted a $700 million, eight year publicly funded study of the benefits of HRT, by The Women's Health Initiative (WHI) three years earlier than planned because of the risks associated with these drugs. Unfortunately, the risks associated with the treatments exceeded the benefits of the drug. Specifically, the study found a higher incidence of serious injury for women who took PremPro compared to those who received a placebo. The main conclusions of the study included:
* The estrogen plus progestin combination does not prevent heart disease.
* For women taking this estrogen plus progestin combination, the risks outweighed the benefits (fewer hip fractures and colon cancers).
The study found that long-term use of PremPro is dangerous because PremPro significantly increases the risk of the following:
* Stroke by 41%.
* Blood Clots by 113%.
* Heart Attacks - Cardiovascular Disease by 22%.
* Breast Cancer by 26%.
The risks were so alarming that the NIH canceled the study in advance of the planned end date citing the risks to the study's participants.
Additionally, the Women's Health Initiative Memory Study (WHIMS), a sub study of the WHI, recently concluded that women treated in the study with PremPro, conjugated estrogens 0.625mg combined with medroxyprogesterone acetate 2.5mg, have a greater risk of developing probable dementia than those on placebo.
A recent study by Newcomer et al., which found that there was a nearly 210 percent risk of developing lobular breast cancer among patients taking a CHRT therapy, PremPro, compared to those not undergoing any type of hormonal therapy treatment. This risk may be as high as 430%.
Another large study that was conducted in the United Kingdom also was stopped prematurely because the founders of the study considered it unlikely that the trial would provide evidence to influence clinical practice in the next 10 years.
In January 2003, Wyeth issued a "Dear Health Care Professional" letter at the request of the Federal Food and Drug Administration (FDA). The letter detailed the new labeling of PremPro, including a "black box" warning stating that estrogen plus progesterone therapies should not be used for the prevention of cardiovascular disease.
Additionally, the warning included information from the Women's Health Initiative/National Institute of Health study detailing the potential adverse side effects of taking PremPro, and advised health care providers to prescribe PremPro for the shortest duration consistent with treatment goals.
The FDA has advised manufacturers of these drugs to continually update their labels based off of results from the Women's Health Initiative (WHI). This information will allow individuals to understand the risks as they are identified.
In March 2003, the FDA approved a new, lower dose of PremPro to help with these goals.
Numerous class action lawsuits have been filed because of injuries caused as a result of taking PremPro.
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