Other safety alerts
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| European Union: The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a new contraindication for Pradaxa (dabigatran etexilate): Prosthetic heart valves requiring anticoagulant treatment. |
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The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Pradaxa.
Detailed conditions for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available after the variation to the marketing authorisation has been granted by the European Commission.
For information, the full contraindication for Pradaxa will be as follows:
• Hypersensitivity to the active substance or to any of the excipients.
• Patients with severe renal impairment (CrCL < 30 mL/min)
• Active clinically significant bleeding
• Lesion or condition at significant risk of major bleeding such as current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities
• Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin etc), heparin derivatives (fondaparinux etc), oral anticoagulants (warfarin, rivaroxaban, apixaban etc) except under the circumstances of switching therapy to or from Pradaxa or when UFH is given at doses necessary to maintain an open central venous or arterial catheter.
• Hepatic impairment or liver disease expected to have any impact on survival.
• Concomitant treatment with systemic ketoconazole, cyclosporine, itraconazole, tacrolimus and dronedarone.
• Prosthetic heart valves requiring anticoagulant treatment.
Please refer to the following website in EMA for details:http://www.ema.europa.eu/docs/en_GB/../WC500136258.pdf
In Hong Kong, Pradaxa 75mg, 110mg and 150mg capsules are registered by Boehringer Ingelheim (HK) Ltd. and are prescription-only medicines. Safety alerts on Pradaxa had been released by various overseas regulatory authorities and the matter was discussed in the meetings of the Registration Committee of the Pharmacy and Poisons Board in April and December 2012. Letters to inform healthcare professionals were issued on 19 August 2011 and 4 November 2011. In view of the updated information from the CHMP, this new issue will be further discussed in the meeting of the Registration Committee. Department of Health will remain vigilant on any updated news of this medicine.
Ends/ Saturday, December 15, 2012
Issued at HKT 14:00pm
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