Tamoxifen Gets “Black Box” Warning
In June of this year, the U. S. Food and Drug Administration (FDA) and AstraZeneca (the makers of Tamoxifen Nolvadex®) announced that the labelling of tamoxifen would be changed. A “black box” warning about the risk of uterine sarcoma will be added to notify doctors and consumers about serious or life-threatening adverse effects including uterine sarcoma, endometrial cancer, stroke, and pulmonary embolism.
The risk of uterine sarcoma applies to all women who take tamoxifen. Despite this, the new warning is directed solely at women with ductal carcinoma in situ (DCIS) or women who have not had breast cancer but are deemed at high risk. The FDA advisory is not directed to women who have already had breast cancer and who take tamoxifen to reduce the risk of a recurrence. In the opinion of the FDA, the benefits of the drug outweigh its risks for women who have already had breast cancer.
(To see the full FDA warning visit: http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#nolvad)
But, as Maryann Napoli from the Center for Medical Consumers, points out, “It is patronizing for the FDA to state that the benefits outweigh the risks. Breast cancer has many levels of severity, and it might not be so clear that the benefits outweigh the risks for, say, a woman with a breast tumour less than 1cm and a family history of blood clots. Whether the benefits outweigh the risks is actually a decision that individual women must make, in consultation with their health care providers.” In other words, it is important to evaluate the risks and benefits in each case to avoid substituting one life-threatening disease for another.
The Prevention First Coalition, of which BCAM is a member, has sent a letter to the FDA and AstraZeneca voicing its concerns.