Opinion ID: 1381810
Heading Depth: 2
Heading Rank: 5

Heading: Wyeth's and Upjohn's Breast Cancer Warnings

Text: The FDA requires drug information to be sent directly to the physician as well as provided to the patient with each prescription. In 1992, both the physician labeling and patient information sheet for Premarin provided the following warning: Some studies have suggested a possible increased incidence of breast cancer in those women on estrogen therapy taking higher doses for prolonged periods of time. The majority of studies, however, have not shown an association with the usual doses used for estrogen replacement therapy. Similar language was included in the physician label and patient information sheet accompanying Prempro prescriptions. [9] The Premarin labeling did not provide any information concerning the combined use of estrogen plus progestin. Both Dr. Parisian and Dr. Kuperman testified that this label did not convey a significant risk of breast cancer associated with the use of estrogen or progestin. The Prempro information sheet included this additional information: Most studies have not shown a higher risk of breast cancer in women who have ever used estrogens. However, some studies have reported that breast cancer developed more often (up to twice the usual rate) in women who used estrogens for long periods of time (especially more than 10 years), or who used high doses for shorter time periods. The effects of added progestin on the risk of breast cancer are unknown. Some studies have reported a somewhat increased risk, even higher than the possible risk associated with estrogens alone. Others have not. Regular breast examinations by a health professional and monthly self-examination are recommended for all women. Regular mammograms are recommended for all women over 50 years of age. Dr. Parisian testified that the Prempro warning was confusing and did not clearly convey a risk to patients. She also testified that it falsely implied that Wyeth had conducted studies to analyze the risk. Dr. Kuperman testified that the warning provided no clear indication of a breast cancer risk and instead implied that the risk was unresolved and that there was likely a low correlation. In 1999, the Prempro label continued to provide the warning contained in the Premarin label, but added, [t]he effect of added progestins on the risk of breast cancer is unknown, although a moderately increased risk in those taking combination estrogen/progestin therapy has been reported. The label provided an example of a clinical trial and concluded that [t]he overall incidence of breast cancer in this clinical trial does not exceed that expected in the general population. Upjohn's Provera provided no warning of breast cancer, and none was required by the FDA until 1999. At that time, the label informed patients of the results of the study on beagle dogs and concluded that the significance with respect to humans has not been established.