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Label Changes for:

Femara (letrozole) 2.5 mg tablets

March 2010

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – March 2010


Bone Effects
  • Use of Femara may cause decreases in bone mineral density (BMD). Consideration should be given to monitoring BMD. Updated results from the BMD sub-study demonstrated that at 2 years patients receiving letrozole had a median decrease from baseline of 3.8% in hip BMD compared to a median decrease of 2.0% in the placebo group. The changes from baseline in lumbar spine BMD in letrozole and placebo treated groups were not statistically different.
  • Consideration should be given to monitoring serum cholesterol. In the adjuvant setting, an increase of ≥1.5 X ULN in total cholesterol (generally non-fasting) was observed in patients who had baseline total serum cholesterol within the normal range in 151/1843 (8.2%) on letrozole vs 57/1840 (3.2%) on tamoxifen. Lipid lowering medications were required for 25% of patients on letrozole and 16% on tamoxifen.


Updated Analysis, Extended Adjuvant Treatment of Early Breast Cancer, Median Treatment Duration of 60 Months
  • The extended adjuvant treatment trial was unblinded early. At the updated (final analysis), overall the side effects seen were consistent to those seen at a median treatment duration of 24 months.