BACKGROUND: Even after the recent approval of newer oral anticoagulants for clinical use, the vitamin K antagonist phenprocoumon remains an important treatment option for many patients. In order to quantify the hitherto "accepted" risks of phenprocoumon treatment, we analyzed adverse drug reactions (ADRs) that led to hospitalization on the internal medicine wards of four German pharmacovigilance centers. METHODS: We prospectively analyzed ADRs leading to hospitalization on the internal medicine wards of the hospitals belonging to the German Network of Regional Pharmacovigilance Centers (Rostock, Greifswald, Jena, and the Sophien- und Hufeland-Klinikum in Weimar) in the years 2000 to 2008. RESULTS: The 851 patients hospitalized for a phenprocoumon-associated ADR accounted for 12.4% of the 6887 ADR-related hospitalizations in the period of the study. 723 (85%) were admitted for a hemorrhage, usually in the gastrointestinal tract (482 patients); 8 patients died as a consequence of hemorrhage associated with phenprocoumon exposure. Using drug utilization data for the catchment areas of the participating hospitals, we calculate a rate of 5 to 7 hemorrhages leading to hospitalization in an internal medicine ward per 1000 patient-years under phenprocoumon treatment. One-third of the patients who had a hemorrhage were taking other interacting drugs, mainly inhibitors of platelet aggregation and non-steroidal anti-inflammatory drugs. Among the patients who were taking phenprocoumon because of a history of thromboembolic events or for atrial fibrillation, 60% to 70% of those who had hemorrhages had an international normalized ratio (INR) that was above the upper limit of the therapeutic range. Phenprocoumon-associated impairment of liver function arose in 23 patients (2.7%). CONCLUSION: In this study, about one-eighth of all ADR-related admissions to hospital internal medicine wards were associated with phenprocoumon. There is a need for a comparative risk-benefit assessment of phenprocoumon and the newer oral anticoagulants under real-life conditions.
BACKGROUND: Even after the recent approval of newer oral anticoagulants for clinical use, the vitamin K antagonist phenprocoumon remains an important treatment option for many patients. In order to quantify the hitherto "accepted" risks of phenprocoumon treatment, we analyzed adverse drug reactions (ADRs) that led to hospitalization on the internal medicine wards of four German pharmacovigilance centers. METHODS: We prospectively analyzed ADRs leading to hospitalization on the internal medicine wards of the hospitals belonging to the German Network of Regional Pharmacovigilance Centers (Rostock, Greifswald, Jena, and the Sophien- und Hufeland-Klinikum in Weimar) in the years 2000 to 2008. RESULTS: The 851 patients hospitalized for a phenprocoumon-associated ADR accounted for 12.4% of the 6887 ADR-related hospitalizations in the period of the study. 723 (85%) were admitted for a hemorrhage, usually in the gastrointestinal tract (482 patients); 8 patients died as a consequence of hemorrhage associated with phenprocoumon exposure. Using drug utilization data for the catchment areas of the participating hospitals, we calculate a rate of 5 to 7hemorrhages leading to hospitalization in an internal medicine ward per 1000 patient-years under phenprocoumon treatment. One-third of the patients who had a hemorrhage were taking other interacting drugs, mainly inhibitors of platelet aggregation and non-steroidal anti-inflammatory drugs. Among the patients who were taking phenprocoumon because of a history of thromboembolic events or for atrial fibrillation, 60% to 70% of those who had hemorrhages had an international normalized ratio (INR) that was above the upper limit of the therapeutic range. Phenprocoumon-associated impairment of liver function arose in 23 patients (2.7%). CONCLUSION: In this study, about one-eighth of all ADR-related admissions to hospital internal medicine wards were associated with phenprocoumon. There is a need for a comparative risk-benefit assessment of phenprocoumon and the newer oral anticoagulants under real-life conditions.
Authors: Naga Chalasani; Robert J Fontana; Herbert L Bonkovsky; Paul B Watkins; Timothy Davern; Jose Serrano; Hongqiu Yang; James Rochon Journal: Gastroenterology Date: 2008-09-17 Impact factor: 22.682
Authors: James Rochon; Petr Protiva; Leonard B Seeff; Robert J Fontana; Suthat Liangpunsakul; Paul B Watkins; Timothy Davern; John G McHutchison Journal: Hepatology Date: 2008-10 Impact factor: 17.425
Authors: Sven Schmiedl; Jacek Szymanski; Marietta Rottenkolber; Bernd Drewelow; Grit Haase; Marion Hippius; Ilselore R Reimann; Werner Siegmund; Karen May; Sara Haack; Jörg Hasford; Petra A Thürmann Journal: Med Klin (Munich) Date: 2007-08-15
Authors: Tom Schalekamp; Johanna H H van Geest-Daalderop; Mark H H Kramer; Angelique T M van Holten-Verzantvoort; Anthonius de Boer Journal: Eur J Clin Pharmacol Date: 2007-02-21 Impact factor: 2.953
Authors: Diana M Rydberg; Lennart Holm; Stefan Mejyr; Desirée Loikas; Karin Schenck-Gustafsson; Mia von Euler; Björn Wettermark; Rickard E Malmström Journal: Eur J Clin Pharmacol Date: 2013-10-06 Impact factor: 2.953