European, UK drug regulators warn of possible dangerous interaction between clopidogrel and PPIs.

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European, UK drug regulators warn of possible dangerous interaction between clopidogrel and PPIs.

Warning Date
2009-06-24
Warning Reason
Correction Actions
Advices to Consumer

The European Medicines Agency (EMEA) has now issued a public statement on a possible interaction between clopidogrel (Plavix) and proton-pump inhibitors (PPIs) and has recommended that the product information for all clopidogrel-containing medicines be amended to discourage concomitant use of PPIs unless absolutely necessary." The UK drug regulator, called the "Medicines and Healthcare Products Regulatory Agency (MHRA), has also issued advice to GPs that concomitant use of a PPI with clopidogrel is not recommended unless considered essential, urging a review of the prescribing of PPIs at the next appointment for patients taking clopidogrel." Meanwhile, the FDA earlier this year issued an "early communication" that "PPIs might interfere with the effectiveness of clopidogrel and that clinicians should reevaluate starting or continuing treatment with a PPI in patients taking clopidogrel." However, "several leading cardiologists have voiced concern that the studies on which these warnings are based have many limitations and that it is far from certain whether there really is an interaction between clopidogrel and PPIs."

Advice for healthcare professionals:

• The need for PPI therapy in patients who are also taking clopidogrel should be reviewed at their next appointment: only use these medicines concomitantly when essential

• Prescribe PPIs strictly in line with their licensed indications

• Check that patients who are taking clopidogrel are not buying over-the counter PPIs




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