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Tuesday, 3 June 2025, 17:15
The Spanish agency for medicines and health products (Aemps) has issued an important warning about the cardiovascular risks associated with high doses of ibuprofen and dexibuprofen. According to the state agency attached to the Ministry of Health, the regular consumption of both medicines for colds and other respiratory conditions, "presents a cardiovascular risk that health agencies highlight".
Following the European review on the cardiovascular risk of ibuprofen and dexibuprofen, Aemps has issued recommendations for use saying that "the lowest effective dose" (200 mg of ibuprofen) should be used "for the shortest possible time". Although paracetamol is prescribed for patients with heart conditions it "can increase blood pressure in coronary patients".
Aemps has explained that the European Pharmacovigilance Risk Assessment Committee (PRAC) has completed its review of the cardiovascular risk associated with systemic administration of ibuprofen. "This review follows on from previous reviews which concluded that NSAID use in general is associated with a small increase in cardiovascular risk," the committee explains.
The PRAC, which is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicines, has assessed the potential interaction between ibuprofen/dexibuprofen and acetylsalicylic acid (ASA) when the latter is administered in low doses in cardiovascular prevention.
Data from clinical trials, observational studies and meta-analyses "confirm that administration of high doses of ibuprofen (equal to or greater than 2,400 mg/day) are associated with an increased risk of arterial thrombosis, this risk being comparable to that of COX-2 inhibitors at standard doses".
The available information does not suggest that ibuprofen doses up to 1,200 mg/day, which are generally used as an occasional analgesic/anti-inflammatory or antipyretic, are associated with an increased cardiovascular risk.
Regarding the potential interaction with acetylsalicylic acid, pharmacodynamic studies indicate that ibuprofen decreases the antiplatelet effect of acetylsalicylic acid. "Although the epidemiological data available to date do not suggest that such an interaction is clinically significant, the possibility that the cardioprotective effect of acetylsalicylic acid is reduced with regular and continuous administration of ibuprofen cannot be excluded," the Aemps notes on its website, which also specifies that these conclusions are equally applicable to dexibuprofen, "bearing in mind that they are not equipotent and 2,400 mg of ibuprofen is equivalent to 1,200 mg of dexibuprofen".
Following the European review on the cardiovascular risk of ibuprofen and dexibuprofen, Aemps recommends the following guidelines to healthcare professionals:
- In patients with severe cardiovascular pathology such as heart failure (New York Heart Association-NYHA classification II-IV), established ischaemic heart disease, peripheral arterial disease or cerebrovascular disease: ibuprofen at high doses (2,400 mg daily or higher) and dexibuprofen at high doses (1,200 mg daily or higher) should be avoided.
- Before initiating long-term treatment with ibuprofen or dexibuprofen, especially if high doses are required, "the patient's cardiovascular risk factors should be considered".
- As with all non-steroidal anti-inflammatory drugs, "the lowest possible dose should be used for the shortest possible time to control symptoms in accordance with the stated therapeutic goal". If dexibuprofen is used, it is reminded that the dose is equivalent to half the dose of ibuprofen.
Aemps indicates to patients using ibuprofen and dexibuprofen that "there is no risk of infarction or arterial thrombosis with occasional use of ibuprofen or if 1,200 mg or less are taken daily".
As with any anti-inflammatory drug, the organisation advises to use "the lowest dose that allows you to control your symptoms for the shortest possible time and follow the instructions on the leaflet".
Finally, patients who are taking prescription doses of 2,400 mg per day or higher of ibuprofen, and have or have had severe heart problems or cerebral thrombosis, are advised to discuss with their doctor whether they should continue treatment at their next scheduled visit.
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