Posters & Accepted Abstracts: J Infec Dis Treat
Objective: To analyse the cases of hepatic adverse effects with antituberculosis drugs in Morocco
Methods: We used the Vigiflow national database, Vigilyze and Excel software
Results: Of the 2271 cases of reports of adverse reactions with antituberculosis drugs, there were 886 cases of hepatic adverse reactions, 39% of all anti-tuberculosis adverse reactions. Since 2011, there has been an annual average of 105 cases of hepatic adverse reactions. The most affected age group was between 18 and 44 years old with 50% of all cases, followed by the age group between 45 and 64 years old with 28% of total cases, with a predominance of females (56.7%). The most incriminated antituberculosis drugs in the occurrence of hepatic adverse reactions are the combined forms including ERIP K4 (67%). During the period 2011-2017 and on all cases of hepatic adverse reactions, there were 397 serious cases which represent 45% of total hepatic adverse reactions with an annual average of 44 serious cases. Taking into account the severity criteria, and among the 397 cases of severe hepatic adverse reactions, 341 cases required hospitalization or prolongation of hospitalization which represents 85% of cases; life-threatening was involved in 28 cases and there were 23 deaths.
Conclusion: Hepatotoxicity due to antituberculosis drugs is very common in Morocco. Among the reported cases of hepatobiliary adverse reactions, the proportion of cases considered serious is significant; the most incriminated antituberculosis drugs are especially those used in combination including ERIP K4; in some Asian and African countries, including Morocco, hepatic disease with antituberculosis constitutes a signal of pharmacovigilance that deserves to be evaluated in order to implement the necessary risk minimization actions.