News Brief: FDA strengthens selected drug warnings
News Brief: FDA strengthens selected drug warnings
The Food and Drug Administration has revised the warnings on the labels of the following drugs:
• Tamoxifen citrate (Nolvadex). Labeling changes for tamoxifen citrate have been prompted by serious, life-threatening, or fatal events associated with the drug in a risk-reduction setting (for women at high risk for cancer and women with ductal carcinoma in situ). These events include endometrial cancer, uterine sarcoma, stroke, and pulmonary embolism. Health care providers should discuss the potential benefits vs. the potential risks of these serious events with women considering tamoxifen citrate to reduce their risk of developing breast cancer. To see the label changes, go to www.fda.gov/medwatch/SAFETY/2002/safety02.htm#nolvad.
• Irinotecan hydrochloride (Camptosar). The label of irinotecan hydrochloride has been revised to identify patients at higher risk of severe toxicity, clarify dose modification guidelines, and augment information about management of treatment-related toxicities, including severe and occasionally life-threatening diarrhea. To see the label changes, go to www.fda.gov/medwatch/SAFETY/2002/safety02.htm#campto.
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