Abstract

Samer Shukur Mohammed41482*, Wael Walid Mustafa41483 and Manal Mohammed Younis41484

Tramadol is codeine analogue with 4-phenyl-piperidine group; it has less analgesic power than morphine but with better abuse potential. However, chronic use associated with different adverse effects like anxiety, euphoria, nervousness, insomnia, depression, agitation. In this study, we assessed the outcome behind restriction of dispensing Tramadol in private health sectors in Iraq.

Methods: To assess Tramadol information gathered through searching in VigiBase data and their related Individual Case Safety Report (ICSR) that is officially supported by WHO global database. All reports were analyzed by Vigilyze mining of data and by computing IC₂₅ to evaluate the strength of association between Tramadol and its related disorders, and comparing it with between with worldwide records.

Results: 184 cases were collected across 7 years of Iraqi Pharmacovigilance Center patient records collection for patients who used tramadol in many dosage forms. Among those, 32 cases showed Hyperhidrosis which occurred when using tramadol alone, 47 patients showed with vomiting and 67 of patients with nausea. Many recorded adverse effects found highly in Iraqi records comparing to that in globally recorded cases like chest discomfort, hyperhidrosis, headache, dyspnea and constipation. While other effects appeared lower than that globally reported like vomiting, hallucination, vertigo, respiratory depression and chills. No death appeared in all cases recorded across this duration.

Conclusion: Due to the restricting tramadol use by ministry of health and dispensing it only in public hospitals and under medical supervision, the number of reported adverse events and the percentage of major adverse events decreased.