Following findings from two recent studies (AAA study and ATT collaboration) that the risk of having a major bleed outweighed any vascular benefit from the use of low-dose aspirin for primary prevention, the MHRA has issued the following reminder in its October Drug Safety Update:

• The results of these recent studies lend support to the licensed indications for aspirin in secondary prevention of vascular events only.

• Aspirin is not licensed for the primary prevention of vascular events.

• If aspirin is used in primary prevention, the balance of benefits and risks should be considered for each individual, particularly the presence of risk factors for vascular disease (including conditions such as diabetes) and the risk of gastrointestinal bleeding.