Dinkes & Schwitzer are currently reviewing a number of cases involving patients who took the pre-menopause drug, Prempro.
The National Heart, Lung and Blood Institute (NHLBI), a division of the National Institutes of Health (NIH), undertook a major clinical trial evaluating the risks and benefits of combined estrogen and progestin with Prempro being the only combination drug tested. However, in July 2002, the NHLBI announced that study had been halted rather than continuing through 2005 as originally set. After an average follow-up period of 5.2 years, the study revealed that there were striking increases in invasive breast cancer, coronary heart disease, stroke and pulmonary embolism in patients taking the combination therapy compared to women taking a placebo.
Participants in the NHLBI study included 16,608 women ages 50 to 79 that had not undergone a hysterectomy. The decision to discontinue the study came in May 2002 when the Data and Safety Monitoring Board (DSMB) held its bi-annual meeting to review the study's data. Previous DSMB reviews revealed increased rates of coronary heart disease, strokes and blood clots. During this meeting, the DSMB reviewed data collected through February 2002, which revealed for the first time a marked increase in breast cancer for women who were taking Prempro compared to those in the placebo group.
Findings showed the following occurred more often in the combination drug group as opposed to the placebo group:
• 41% increase in strokes
• 22% increase in total cardiovascular disease
• 29% increase in heart attacks
• 26% increase in breast cancer
• 100% increase in blood clots
Since that time, a number of reports have examined the possible effects of Prempro. Thanks to those reports, women have become much more aware of the risks associated with hormone replacement therapies.
Serious side effects of Prempro can include increase risk of:
• Heart disease
• Heart attack
• Stroke
• Breast cancer
Recently, Wyeth, the manufacturer of Prempro, announced they would change the packaging to include a warning of possible increased risks of using this drug. Contact us if you or a family member have taken Prempro and would like more information concerning your legal rights.
Put proven injury lawyers on your side. Contact Dinkes & Schwitzer at 1-800-933-1212 for your free legal consultation.
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