FDA Panel OKs Evista for Breast Cancer
Experts Recommend the Osteoporosis Drug for Use in Preventing Breast Cancer
Potential Risks continued...
"Considering that most women will not develop breast cancer in their
lifetimes ... taking raloxifene and tamoxifen as a risk reduction measure will
be unnecessary for most," she says.
Some panelists urged the FDA to restrict the drug's marketing, particularly
to keep it out of the hands of women at risk for cardiovascular disease. One
panelist even suggested issuing a "black box" warning for Evista.
"There should be a strong effort to limit potential harm," says Curt
D. Furburg, MD, a Wake Forest University professor of public health who voted
to approve the new use for Evista.
Lilly paid $36 million in fines in 2005 after pleading guilty to illegally
promoting Evista as a cancer-fighting drug. Critics said approving the new use
for the drug would clear the way for the company to promote the drug with
Gwen Krivi, PhD, vice president of Lilly Research Laboratories, says the
company will "continue working with the FDA to make this important option a
reality for patients."
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