- 41 Downloads
An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In French National pharmacovigilance database, 15 patients [9 women and 6 men] aged 21–89 years were described, who developed myalgia, arthralgia, joint stiffness, joint pain, muscle pain, sacroiliac pain, abdominal pain, thrombocytopenia, nausea or arthritis [not all durations of treatments to reactions onsets stated] during treatment with amiodarone, cetirizine, fluindione, furosemide, fusidic acid, mianserin, ofloxacin, omeprazole, oxacillin, prednisone, prednisolone, pristinamycin, ramipril or rifampicin [dosages, routes and indications not stated].
Patient 1: A 61-year-old woman started receiving treatment with pristinamycin. A few hours after initiation of pristinamycin therapy, she developed generalised myalgia, arthralgia and abdominal pain. Subsequently, pristinamycin...