The SPC now states that, "post-marketing cases of myocardial infarction have been reported in patients taking varenicline".
It should be noted that post-marketing surveillance data such as this is observational and is therefore open to bias. For example, the observed myocardial infarctions may have been due to the existing smoking status of the patient, other cardiovascular factors that existed in the patient or this may be a genuine issue with varenicline.
Action: Despite this observational nature of this data it may still be prudent to exercise caution when considering using varenicline in patients who have already experienced or who are at risk of a myocardial infarction.
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