Abstract

SUMMARY Introduction and objectives: The increase in oral anticoagulants prescription has caused an increase in intracranial hemor rhages, the most adv erse reaction to this phar macological g roup. The objecti ve of this study is to e valuate the a voidability of the intracranial hemor rhages associated with oral anticoagulants that require hospitalization of patients with atrial fibrillation. Methods : Sur vey of the medical histories of the patients w ho w ere hospitalized in the Uni versity Hospital «V irgen del Rocio» (from 01/01/03 to 03/31/07) with intracranial hemor r- hages and atrial fibrillation, considering as intracranial hemor rhages associated with oral anticoagulants those with a probab le relationship appl ying the causality algorithm of the Spanish Phar macological Sur veillance System. In order to e valuate the a voidability of the intracra - nial hemor rhage the risk/benefit ratio of the use of oral anticoagulants has been studied. Results : At least 20 out of 57 (35.1%) intracranial hemor rhages associated with oral anticoagulants w ere potentiall y a voidable, in 7 cases out of those 20 (35 %) death w as the outcome, and in 8 out of the remaining 13 (61.5%) the sur vivors suf fered after-ef fects. Omeprazole w as the dr ug more frequentl y in volved in interactions with oral anticoagulants in 11 out of 57 cases (19%) although this interaction is cate gorized as highl y probab le in the bib liography and the protocols of the Hospital. Conclusions : The risk / benefit ratio of oral anticoagulants, the strict control of the Inter national Nor malized Ratio and the possib le dr ug interactions, must be assessed indi vidually and re gularly to minimize the risk of intracranial hemor rhage that is often a potentially avoidable lethal adverse event.

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