2007 Diclofenac Induced Leucopenia in 48-Year-Old Male Patient

Saturday, 8 December 2012
Hall 4 (HICC)

Vesna Radovic, PhD , Pharmacovigilance, STADA Hemofarm A.D., Belgrade, Serbia

Background: This report was received from a physician via the Medicines and Medical Devices Agency of Montenegro (CALIMS) on 2011-September-14.

Methods: case report.

Results: A 48-year-old male patient was appeared in the emergency room. The patient suffers from Discus hernia. 2011-August-22 - choking, hives all over the body. The patient was appeared in the emergency room, where he was received injections Urbazone, after which they withdrew changes. Per anamnesis: today - hyperemia whole body, itching, burning eyes, a sense of tightening in the throat. Objectively: oedema and hyperemia skin and whole body, hyperemia conjunctiva. Patient was received Dexazone and Urbazone. The patient was receiving therapy 4 days from: 2011-August-22 to: 2011-August-25.

Conclusions: This case was classified as serious. The causal relationship between diclofenac and the suspected adverese reaction was assessed as possibly related based on the temporal association and the known safety profile. This case does not change the overall benefit-risk balance of the medicinal product.