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Home Page >> Drugs/Medical News >> Wyeth's Prempro
Wyeth's Prempro2007-03-22Wyeth Loses Prempro Lawsuit Heidi Turner Madison, NJ: Last month a jury awarded $3 million to an Ohio woman who argued that the use of Prempro resulted in her developing breast cancer. The plaintiff was diagnosed with breast cancer in 2001 after she had taken Prempro for five years to treat symptoms of menopause. The lawsuit claimed that Wyeth knew for a long time that use of Prempro could lead to breast cancer but did not warn patients about the risk. After her breast cancer diagnosis, the plaintiff underwent a double mastectomy and also had radiation and chemotherapy treatments. She had won an earlier trial but a judge later threw out the verdict and declared a mistrial. Wyeth faces approximately 5,200 lawsuits on behalf of around 8,400 women who claim that the drug maker downplayed the negative side effects associated with Premarin and Prempro. So far Wyeth has won two cases and lost two cases. Lawyers for the plaintiffs are arguing that Wyeth aggressively promoted Prempro for off-label uses. A 2002 study found that use of Prempro increased the risks of breast cancer, heart attacks and stokes. The study found that in 10,000 women taking a placebo, 30 would have breast cancer or heart attacks. For 10,000 women taking Prempro, 37 would have breast cancer and 38 would have a heart attack. Those numbers may seem small but over a large population, that difference can result in tens of thousands of cases of breast cancer and heart attacks. The difference was enough of a concern that the study, which was scheduled to continue for eight years, was stopped after five years. Based on the results of the study, Wyeth added a boldfaced warning on both Prempro and Premarin. Prempro, known generically as conjugated estrogens and medroxyprogesterone, is still on the market and has the approval of the US Food and Drug Administration (FDA). Doctors should be checking their patients every three to six months to determine whether or not to continue with the medication. Prempro is used to treat symptoms of menopause such as hot flashes, irritation, and night sweats. Prempro is pregnancy category X because it can cause birth defects in newborn babies. Women who are taking Prempro should take every precaution to avoid becoming pregnant. Use of Prempro can also lead to endometrial hyperplasia, which is a condition that can lead to uterine cancer. Wyeth was formerly known as American Home Products and was responsible for the drug cocktail fen-phen that was pulled off the market after it was linked to heart valve disease. In 1999, the drug manufacturer paid $3.75 billion in a settlement that was split among thousands of fen-phen users. The company also came under scrutiny in 2005, when an FDA inspection at the company's facility in Guayam, Puerto Rico found violations of good manufacturing practices including impurities in drugs and improper clearing of packing machines. Prempro was one of the drugs found with impurities. The inspection resulted in a warning letter from the FDA to Wyeth which led to the drug manufacturer taking steps to comply with FDA regulations. A re-inspection is currently being carried out. Prempro Legal HelpIf you or a loved one has suffered from breast cancer as a result of taking taken progestin or a combination of progestin and estrogen, or you were diagnosed with breast cancer while taking HRT or within one year thereafter, please contact a [Prempro] lawyer who will evaluate your claim at no charge. |
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