Recently, the nation's biggest hormone replacement study, conducted by the National Institute of Health (NIH), concluded that long-term use of PremPro is dangerous and outweighs its potential benefits because PremPro significantly increased the risk of stroke, blood clots, heart attacks and breast cancer. The risks were found to be so alarming that the NIH canceled the study in advance of the planned end date citing risk to the study's participants.
Another large study that was conducted in the United Kingdom also was stopped prematurely because the funders of the study considered it unlikely that the trial would provide evidence to influence clinical practice in the next 10 years.
PremPro is a form of Hormone Replacement Therapy (HRT) that consists of a single tablet containing 0.625 mg of the estrogens found in Premarin ® tablets and 2.5 mg or 5 mg of medroxyprogesterone acetate (MPA). PremPro is manufactured by Wyeth and accounted for $890 million of the company's $13.9 billion in sales in 2001. Approximately six million women are reported to be taking PremPro to treat post-menopausal hot flashes and other menopause symptoms. It is important to understand that PremPro is a Combined Hormone Replacement Therapy (CHRT) because it consists of both an estrogen and progesterone, unlike other HRT which consists of one or the other.
Ever since HRT was introduced, there has been concern amongst physicians and scientists regarding a possible increase in the risk of breast cancer. Numerous epidemiological studies have evaluated this risk and have been published in the world's medical literature. In the majority of studies, long term, recent use of HRT has been associated with an increased risk of breast cancer. Women taking Prempro have been noted to have a significantly increased risk of breast cancer, specifically a rare form of breast cancer known as lobular breast cancer. A recent study by Newcomer et al., observed that among women who used combined HRT (like PremPro) there was a 210% increased risk of lobular breast cancer over women who had never used any type of HRT. This risk may, in fact, be as high as 430%.
The attorneys at Lopez, Hodes, Milman & Skikos are representing women nationwide in claims against Wyeth and other manufacturers of combination hormone therapy. Most of these cases have been or will be transferred to the federal multi-district litigation In re PremPro Products Liability Litigation that is pending in the United States District Court, for the Eastern District of Arkansas, Western Division.
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