The use of low-dose aspirin in the prevention of heart attacks and stroke has been studied in patients with no history of cardiovascular disease. Two separate studies concluded that any vascular benefit was outweighed by the risk associated with a gastrointestinal bleed.
Low-dose aspirin is licensed in the UK for secondary prevention of cardiovascular and thrombotic cerebrovascular disease. The use of aspirin for the primary prevention of vascular disease is an unlicensed indication and would be outside of the product licence.
The Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) have advised healthcare professionals that the recent evidence supports the licensed use of aspirin of vascular events in secondary prevention only. If aspirin is used in primary prevention for which its use would be unlicensed an analysis of the risk versus benefit needs to considered for each individual patient, taking into account the presence of any risk factors for vascular disease and the risk of gastrointestinal bleeding.
Members should take this advice into account when making over the counter sales for low dose aspirin.
Click on the link below for more details direct from the MHRA website.