EU Committee Confirms Increased Risk with Ibuprofen at High Doses

Regulatory NewsRegulatory News | 13 April 2015 |  By 

A European committee has confirmed that high doses of ibuprofen, a popular over-the-counter (OTC) anti-inflammatory drug, can increase a patient's risk for cardiovascular issues.


Ibuprofen belongs to a class of drugs, called non-steroidal anti-inflammatory drugs (NSAIDs), which includes drugs such as diclofenac, naproxen and aspirin. NSAIDs already have a warning about increased risk of blood clots included in the information distributed with such products in the EU. The warning recommends that NSAIDs should "be used at the lowest effective dose and for the shortest period of time necessary," to reduce cardiovascular risks.

PRAC's Recommendations

The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has said that patients taking ibuprofen at doses of 2,400 mg or more per day are at a higher risk of heart attack or stroke than those taking lower doses. Healthcare providers are advised to weigh the risks of prescribing doses of 2,400 mg or greater, and take into consideration a patient's cardiovascular history and other risk factors. To ensure safe prescribing, PRAC is recommending the European Commission (EC) update the product information for products containing ibuprofen to reflect the greater risk associated with high doses.

The committee also clarified that the level of risk does not increase when taking up to 1,200 mg of ibuprofen, which is typically the highest recommended dose for OTC versions. OTC ibuprofen products usually advise taking up to 200–400 mg, 3-4 times daily; however, patients are sometimes prescribed 800 mg formulations of the drug.

The review also looked at possible interactions between ibuprofen and low-dose aspirin, which often is prescribed to reduce clotting. The reviewers noted that some studies found ibuprofen to reduce the anti-clotting properties of aspirin, but did not have enough data to determine the effect of the long-term simultaneous use of both drugs. PRAC recommends that product information for ibuprofen should also be updated to include information about possible interactions between ibuprofen and aspirin.

Next Steps

Now that PRAC has completed its review, the recommendations will move to the Coordination Group for Mutual Recognition and Decentralised Procedures—Human (CMDh). If CMDh adopts the recommendations, they will automatically take effect in Member States where ibuprofen is authorized, and be brought to the EC to consider for EU-wide adoption.


EMA Press Release


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