Source: US Food & Drug Administration
Wyeth’s Prempro (a hormone replacement drug) was the subject of a Nevada jury verdict (recently upheld by the Supreme Court of Nevada) awarding $57.7 million to 3 women diagnosed with Prempro induced breast cancer. $35 million of that award was in the form of punitive damages for downplaying the risks associated with the drug.
The FDA mandated significant revisions to the labeling of Prempro following the watershed estrogen plus progestin sub-study of the Women’s Health Initiative (WHI) which reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE 0.625 mg) combined withmedroxyprogesterone acetate (MPA 2.5 mg).
The estrogen alone substudy of the WHI reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with daily CE 0.625 mg. The required labeling changes for Prempro include the following Warning:
WARNINGS
Malignant Neoplasms: Breast Cancer
The most important randomized clinical trial providing information about this issue in estrogen plus progestin users is the Women’s Health Initiative (WHI) substudy of daily conjugated estrogens (CE 0.625 mg) plus medroxyprogesterone acetate (MPA 2.5 mg). In the estrogen plus progestin substudy, after a mean follow-up of 5.6 years, the WHI substudy reported an increased risk of breast cancer in women who took daily CE/MPA…
If you or a loved one have been taking Prempro and have any health concerns we urge you to contact your prescribing physician. If you or a loved one have been diagnosed with myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis (DVT) following routine receipt of Prempro we urge you to contact the Lewis Law Firm.
Post: David M. Schwadron, Esquire