EMA Starts Safety Review of High-Dose Ibuprofen

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 06-13-2014 12:03


The European Medicines Agency's Pharmacovigilance and Risk Assessment Committee (PRAC) has started a review to evaluate the cardiovascular risks with systemic ibuprofen medicines (such as those taken by mouth but not topical medicines like creams and gels). The cardiovascular risks being evaluated concern high-dose ibuprofen (2,400 mg per day) taken regularly for long periods. Ibuprofen is usually taken at lower doses and for short periods of time.

EMA said in a statement that there is therefore no suggestion of a similar cardiovascular risk with ibuprofen as used by the overwhelming majority of patients. Ibuprofen is one of the most widely used medicines for pain and inflammation and has a well-known safety profile, particularly at usual doses.

Ibuprofen belongs to a class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). The safety of these medicines, including their cardiovascular risks, has been under close review by the EMA and national regulatory authorities for many years. Data, in particular the results of a published analysis of clinical trial data, have suggested that the cardiovascular risk with diclofenac and high-dose ibuprofen (2,400 mg) may be similar to the known risk with COX-2 inhibitors (also of the NSAID class). In 2013, the PRAC considered the available data relating to diclofenac and issued recommendations to minimize their risks. The PRAC is now considering the available data relating to high-dose ibuprofen.

The review of ibuprofen was initiated on June 9, 2014 at the request of the UK’s Medicines and Healthcare products Regulatory Agency, under Article 31 of Directive 2001/83/EC. It follows concerns that high doses of ibuprofen could have a similar cardiovascular risk to those of COX-2 inhibitors.

PRAC, which is the committee responsible for the evaluation of safety issues for human medicines, will make a set of recommendations. As ibuprofen medicines are all authorized nationally, the PRAC recommendation will be forwarded to the Co-ordination Group for Mutual Recognition and Decentralized Procedures–Human (CMDh), which will adopt a final position. The CMDh, a body representing EU member states, is responsible for ensuring harmonized safety standards for medicines authorized via national procedures across the EU.

Source: EMA


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