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EMEA Recommends Clopidogrel Label Change to Include Possible PPI Interaction LONDON -- June 3, 2009 -- The European Medicines Agency (EMEA) is aware of studies suggesting that clopidogrel may be less effective in patients receiving proton pump inhibitor (PPI). This could result in patients being at an increased risk of thrombotic events, including acute myocardial infarction (MI). The new concern relates to several recently published studies examining clinical outcomes of clopidogrel users. Taken together, these studies suggest that a significant interaction might occur between clopidogrel and members of the PPI class of medicines, making clopidogrel less effective when given with these medicines. One possible explanation for this observation is that some PPIs prevent the conversion of clopidogrel into its biologically active form in the body, reducing the effectiveness of clopidogrel and increasing the risk of MI or other conditions involving harmful clotting. However, as different PPIs have different capacity to affect the metabolism of clopidogrel and as the outcome studies have not fully reflected the different effect of PPIs on activation of clopidogrel, there may be more than 1 explanation for the effect of this class of medicines on clopidogrel. Taking all the data into account, the Agency's Committee for Medicinal Products for Human Use (CHMP) and its Pharmacovigilance Working Party (PhVWP) have recommended that the product information for all clopidogrel-containing medicines should be amended to discourage concomitant use of PPI and clopidogrel-containing medicines unless absolutely necessary. Accordingly, the marketing authorisation holders for the clopidogrel-containing medicines will shortly be submitting variation applications in order to amend the product information. Furthermore, CHMP recommended that further information is needed in relation to the inhibition of clopidogrel metabolism by other medicines, and in relation to the implications of genetic variation which results in a small proportion of individuals being unable to fully convert clopidogrel to its active form, regardless of interactions with other medicines. SOURCE: European Medicines Agency E-mail this page to a friend or colleague! To print, use this version