Safety Alerts
Medication errors arising from brand name confusion between Pradax®(dabigatran etexilate) and Plavix® (clopidogrel hydrogen sulphate) in Canada
Audiences
Healthcare professional
Industry member
Product type
Therapeutic Products
20 April 2012
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There have been incidences of medication errors which occurred in Canada arising from the confusion of brand names between Pradax® (dabigatran etexilate) from Boehringer Ingelheim (Canada) Ltd. and Plavix® (clopidogrel bisulfate) from Sanofi-Aventis Canada Inc. In Singapore, although the brand name of dabigatran is slightly different, HSA would like to highlight this issue to healthcare professionals so that similar errors can be avoided here.
Dabigatran is marketed under the brand name of Pradaxa® in Singapore since August 2009 by Boehringer Ingelheim Singapore Pte Ltd. It is an oral anticoagulant (direct thrombin inhibitor) indicated for the prevention of venous thromboembolic events in adult patients following total hip or knee replacement surgery and for prevention of stroke and systemic embolism in patients with atrial fibrillation, in whom anticoagulation is appropriate. Pradaxaâ is available in 75mg, 110mg and 150mg capsules.
Clopidogrel (Plavix®, Sanofi-Aventis Singapore Pte. Ltd) is an oral platelet aggregation inhibitor locally licensed since June 1998, for the prevention of atherothrombotic events in adult patients with myocardial infarction, ischaemic stroke, acute coronary arterial syndrome or established peripheral arterial disease. Plavix® is available as 75mg tablets.
Information from Health Canada
In November 2011, Health Canada issued a safety advisory on the risk of potential patient harm associated with brand name confusion between Pradax® and Plavix®. Since January 2011, a total of five Canadian cases, associated with drug name confusion between Pradax® and Plavix®, have been received by Boehringer Ingelheim (Canada) Ltd. and Health Canada, including one case resulting in patient harm (non-serious bleeding after a medical procedure). These mix-ups have been associated with similarities in the sound of the tradenames, the spelling of the tradenames and the similar strengths that they are available in. The fact that they are both used in patients with cardiovascular disorders also lead to a higher likelihood of mix-up.
HSA's advisory
Although both products are anti-thrombotic agents, they have different mechanisms of action, indications dosing regimens, and drug interaction profiles. Receiving Pradaxa® instead of Plavix®, or vice versa, may result in inappropriate treatment of the condition as well as the wrong dosage being administered. This may have significant risks including increased risk of bleeding, stroke, systemic embolism, venous thromboembolic events (VTE), atherothrombotic events or other unknown medical outcomes.
HSA would like to highlight this potential risk to the healthcare professionals when prescribing, dispensing and administering these two drugs. As recommended in the MOH Medication Safety Practice Guidelines & Tools, healthcare professionals are encouraged to use the generic names of the drugs when prescribing to avoid any potential confusion.