Safety changes have been made to the labeling of the migraine treatment almotriptan malate (Axert) that include reports of acute myocardial infarction, which occurred within a few hours of almotriptan administration.

The FDA has also received at least one report of coronary vasospasm in a patient with no history of heart disease and documented evidence of an absence of coronary disease. Because the adverse events occurred in close proximity to the use of almotriptan, the FDA states that a causal relationship cannot be ruled out. However, the agency noted that because of the nature of post-marketing surveillance, it is impossible to definitively determine the proportion of the reported adverse events that were actually caused by almotriptan or to reliably assess causation in individual cases.