Isn't it ironic? Just a couple of years after paying a fine for the illegal promotion of Evista as a breast cancer prevention drug, manufacturer Eli Lilly has finally gained FDA approval for the use of the popular osteoporosis drug for prevention of breast cancer in postmenopausal women. Evista, or raloxifene, can now be prescribed for postmenopausal women at high risk of breast cancer, as well as for postmenopausal women with osteoporosis.
The medication is a SERM (selective estrogen receptor modulator), just like its sister drug tamoxifen, a prominent breast cancer drug. That means that that both drugs operate on certain areas of the body as estrogen would - in Evista's case, most notably, by protecting bone density. But these drugs are believed not to produce the detrimental effects of estrogen in other areas, such as on the breast. Specifically, their chemical similarity to estrogen allows them to block the receptors on some cells that might otherwise be prone to be affected by estrogen-induced cancer.
While tamoxifen has grown to be one of the most widely used breast cancer drugs, and is often prescribed to patients in remission to help prevent recurrence, it was widely speculated that Evista's properties could allow it to work on a similar fashion, perhaps with fewer side effects. Despite promising preliminary studies on the hypothesis, FDA approval for this use lagged, and Eli Lilly was punished for acting prematurely by advertising the breast cancer properties of the drug.
Does the FDA's recent decision, however, vindicate the manufacturer? It's a tough question. Like all medications, Evista also has the potential for side effects, specifically blood clots and stroke. The FDA panels evaluating the drug debated long and hard whether Evista's proven benefits against breast cancer were worth the known risks for other health problems. Ultimately, it was decided those with the greatest predisposition for breast cancer deserved more options for treatment. This doesn't mean that everyone now taking tamoxifen should immediately switch to raloxifene/Evista, or that those already taking Evista can cease monthly breast self-examinations or regular mammograms because they are somehow immunized from cancer.
Clearly, some women on tamoxifen to prevent breast cancer, or those who are taking a different osteoporosis drug but are at risk of breast cancer, may now want to consider discussing their new alternatives with their physician. However, it is clear that Evista is not necessarily the best recourse in all situations, and those at risk of cardiovascular disease should proceed with particular caution. It is imperative to consult with your doctor about all the drugs you are taking and to carefully evaluate your complete medical history before changing any prescription regimen. And for those who do decide to take Evista after careful consultation with their doctors, they can be confident that the potential benefits of their medicine have been vetted for years by numerous doctors and have finally met the standards of a reluctant FDA.