Antineoplastic AgentsFemara (letrozole) Tablets
Drug Approval Classification: Supplemental New Drug Application (Approval Date: 01/17/03)
Clinical Summary: The package labeling of Femara (letrozole) has been revised to include new safety and efficacy data regarding the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. The new labeling contains data following patients to 32 months; previously, the package labeling contained data on patients who were followed for 18 months. Table 1 and Table 2 summarize the changes in data contained in the Femara product labeling.
Precautions: The following statement was added to the "Precautions" section of the Femara labeling:
Since fatigue and dizziness have been observed with the use of Femara and somnolence was uncommonly reported, caution is advised when driving or using machinery.
Medscape Pharmacists. 2003;4(1) © 2003 Medscape
Cite this: March 2003 - Medscape - Mar 20, 2003.