The prescription NSAID labels will be revised to reflect the following information:
• The risk of heart attack or stroke can occur as early as the first weeks of using an NSAID. The risk may increase with longer use of the NSAID.
• The risk appears greater at higher doses.
• It was previously thought that all NSAIDs may have a similar risk. Newer information makes it less clear that the risk for heart attack or stroke is similar for all NSAIDs; however, this newer information is not sufficient to determine that the risk of any particular NSAID is definitely higher or lower than that of any other particular NSAID.
• NSAIDs can increase the risk of heart attack or stroke in patients with or without heart disease or risk factors for heart disease. A large number of studies support this finding, with varying estimates of how much the risk is increased, depending on the drugs and the doses studied.
• In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke following NSAID use than patients without these risk factors because they have a higher risk at baseline.
• Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack.
• There is an increased risk of heart failure with NSAID use.
The safety of NSAIDs has been reviewed regularly by authorities in the EU over the past few years. Reviews carried out in 2005, 2006, and 2012 confirmed that NSAIDs as a class are associated with a small increase in the risk of arterial thromboembolic events, especially in patients with underlying heart or circulatory conditions or with certain cardiovascular risk factors, and particularly if used at high doses. A class warning of this risk is in place and the product information for all NSAIDs recommends that these medicines be used at the lowest effective dose and for the shortest period of time necessary to control symptoms.
Naproxen and low-dose ibuprofen (≤1200 mg per day) are considered to have the most favourable thrombotic cardiovascular safety profiles of all NSAIDs, whereas diclofenac is considered to have a similar risk to the selective COX-2 inhibitors. A recent EU review concluded that the cardiovascular risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac – please see an article from the MHRA at the link below for further information