The most frequently reported adverse reactions in the clinical studies were hot flushes, arthralgia, nausea and fatigue. Many adverse reactions can be attributed to the normal pharmacological consequences of oestrogen deprivation (e.g. hot flushes, alopecia and vaginal bleeding). The following adverse drug reactions, listed in Table 9, were reported from clinical studies and from post marketing experience with Letrozole.
Tabulated summary of adverse drug reactions from clinical trials: Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: very common ≥10%, common ≥1% to <10%, uncommon ≥0.1% to <1%, rare ≥0.01% to <0.1%, very rare <0.01%, not known (cannot be estimated from the available data). (See Table 9.)
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Description of selected adverse drug reactions: Cardiac adverse reactions: In the adjuvant setting, in addition to the data presented in Table 5, the following adverse events were reported for Letrozole and tamoxifen, respectively (median treatment duration of 5 years): angina requiring surgery (1.0% vs. 1.0%); cardiac failure (1.1% vs. 0.6%); hypertension (5.6% vs. 5.7%); cerebrovascular accident/transient ischaemic attack (2.1% vs. 1.9%).
In the extended adjuvant setting for Letrozole (median duration of treatment 5 years) and placebo (median duration of treatment 3 years), respectively: angina requiring surgery (0.8% vs. 0.6%); new or worsening angina (1.4% vs. 1.0%); myocardial infarction (1.0% vs. 0.7%); thromboembolic event* (0.9% vs. 0.3%); stroke/transient ischaemic attack* (1.5% vs. 0.8%) were reported.
Events marked * were statistically significantly different in the two treatment arms. Skeletal adverse reactions.
For skeletal safety data from the adjuvant setting, please refer to Table 5.
In the extended adjuvant setting, significantly more patients treated with Letrozole experienced bone fractures or osteoporosis (bone fractures, 10.4% and osteoporosis, 12.2%) than patients in the placebo arm (5.8% and 6.4%, respectively). Median duration of treatment was 5 years for Letrozole, compared with 3 years for placebo.
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