FRIDAY, Sept. 14, 2007 (HealthDay News) -- The Eli Lilly drug Evista (raloxifene) has been approved by the U.S. Food and Drug Administration to reduce the risk of invasive breast cancer among postmenopausal women at high risk for the disease and among postmenopausal women with osteoporosis.
The agency's decision followed recommended approval in July for these new uses by an FDA expert advisory panel, despite concerns that the drug could increase the risks of blood clots and fatal stroke in some women.
Evista was first approved in 1999 to prevent osteoporosis in postmenopausal women.
In a statement, Lilly said the drug's label would now include a boxed warning stressing that women with a history of blood clots known as venous thromboembolisms should not take Evista, and that women at risk for stroke should consult a physician before using the drug.
Women who are pregnant, nursing or who could become pregnant shouldn't take the drug either, Lilly said, and those with kidney or liver problems should speak with their doctor first.
The FDA has more about the approval.