Published: 2 September 2015

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Ibuprofen and Cardiovascular Risk

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Prescriber Update 36(3): 42
September 2015

Medsafe and the Medicines Adverse Reactions Committee (MARC) recently evaluated the risk of cardiovascular events with the use of ibuprofen. The available data suggested that a dose-response relationship exists.

The MARC concluded that there is a small increased risk of cardiovascular thrombotic events when ibuprofen is used at high doses (2400 mg per day). Lower doses of ibuprofen of 1200 mg per day or less (the dose generally used for over-the-counter [OTC] preparations) were not associated with this increased risk.

Overall, the benefit to risk of harm balance for ibuprofen as well as other non-steroidal anti-inflammatory drugs (NSAIDs) remains positive (www.medsafe.govt.nz/profs/adverse/Minutes161.htm#3.2.3).

It is recommended that the lowest effective dose of ibuprofen should be used for the shortest possible duration. Patients requiring high dose ibuprofen therapy should be reviewed regularly to check for efficacy of treatment, adverse effects and the development of cardiovascular risk factors.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease should only be treated with high dose ibuprofen after careful consideration of potential risks and benefits. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (eg, hypertension, hyperlipidaemia, diabetes mellitus and smoking).

There is no consistent evidence that the concurrent use of aspirin mitigates the possible increased risk of cardiovascular events associated with NSAIDs but aspirin will significantly increase gastrointestinal risk.

As a result of the MARC review, several changes have been made to the ibuprofen data sheets to ensure they contain the most up-to-date information. There is currently no legal requirement for data sheets for OTC preparations. Data sheets are published on the Medsafe website (www.medsafe.govt.nz/Medicines/infoSearch.asp).

Further information on ibuprofen and cardiovascular safety, including a summary of data, is available on the Medsafe website (www.medsafe.govt.nz/safety/EWS/2015/Ibuprofen.asp).