Dear Healthcare Professional Letter on the association of clopidogrel (medicinal products Plavix 75 mg and 300 mg film coated tablets and Duoplavin 75 mg/75 mg and 75/100 mg film-coated tablets) with acquired haemophilia
26.08.2013
sanofi-aventis Croatia d.o.o., the representative of the marketing authorisation holder Sanofi Pharma Bristol-Myers Squibb SNC in the Republic of Croatia for medicinal products Plavix 75 mg and 300 mg film-coated tablets and Duoplavin 75mg/75mg and 75 mg/100 mg film coated tablets, has in collaboration with the Agency for Medicinal Products and Medical Devices (HALMED) sent out a letter to healthcare professionals about an important information related to the use of clopidogrel.
The letter informs healthcare professionals about the new and special warnings and cautionary measures related to the use of those medicines due to their association with the acquired haemophilia.
A small number of cases of acquired haemophilia associated with clopidogrel treatment in individuals with no previous history of abnormal haemostasis have been reported. Acquired haemophilia must be promptly recognised to minimise the time the patient is at risk of bleeding and avoid major bleeding. In case of confirmed isolated activated Partial Thromboplastin Time (aPTT) prolongation with or without bleeding, acquired haemophilia should be considered. Patients with a confirmed diagnosis of acquired haemophilia should be treated by specialists, clopidogrel should be discontinued and invasive procedures should be avoided. The new information provided in this letter has been included in the Summary of Product Characteristics for medicinal products Plavix 75 mg and 300 mg film-coated tablets and Duoplavin 75 mg/75 mg and 75/100 mg film-coated tablets.
Here you may view the Dear Healthcare Professional Letter.
HALMED has not received by now any report to acquired haemophilia associated with clopidogrel. HALMED will continue to monitor the safe use of clopidogrel and will inform the public promptly about any new information
We remind healthcare professionals that they should report any adverse reaction to HALMED, as well as quality defect. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult with their doctor or pharmacist about the continuation of their therapy.
