Intensive Pharmacovigilance study, carried out in mexican population with a history of acute myocardial infarction or angina treated with clopidogrel, generic drug, for secondary prophylaxis

Arcelia H A*, Eduardo H A J, Helios V G, Ricardo Z, José Luis R S

Fray Bernardino de Sahagún, Mirador del Punhuato, Morelia, Michoacán, Mexico, North America

ABSTRACT

The results obtained from an intensive pharmacovigilance, phase IV, single-center study, with an oral treatment for secondary prophylaxis of acute myocardial infarction or angina with clopidogrel, generic drug, in Mexican population, at a daily dose of 75 mg, alone or associated with acetylsalicylic acid, are described. A total of 60 patients were admitted; 10 patients were discontinued from the study due to different causes. The patients had, at least, 2 comorbidities in addition to heart disease. Among the most important history were obesity 40% and overweight 41.6%; the age range (tenths) with the greatest number of participants was 51 to 60 years with 25 patients, which represents 41.6%. A total of 247 adverse events were reported (57 patients had adverse events) of which 39 (15.7%) events were heart events, 32 (12.9%) vascular events; 14 (5.7%) events were serious, 9 (3.6%) of the serious events were heart events, 2 (0.8%) vascular events and 3 (1.2%) lithiasis; Of the 24 (9.7%) events, than were classified with a possible causal relation with clopidogrel, 1 (0.4%) was classified as serious. All the other events were non-serious. It was, therefore, concluded that generic clopidogrel is safe, and risk possibility should continue to be monitored for the type of disease that patients suffer and that may have a fatal outcome

Keywords:

Pharmacovigilance, generic drugs, adverse event, Med-DRA method