Objectives: Analysis of all cases of tetrabamate (Atrium)-induced hepatotoxicity reported in the Andalusian Registry of drug-induced liver disorders and comparison with cases reported in the literature.
Material and method: Information was gathered in a structured protocol. The causal role of tetrabamate was estimated in each case using the diagnostic scale of the Council for International Organizations of Medical Sciences (CIOMS).
Results: Of 327 cases of hepatotoxicity, 7 (2%) were due to tetrabamate. The mean age was 57 years (4 men). In 57% of the cases, the presenting symptom was tremor. The latency period was between 15 and 730 days. Liver damage was mainly cytolytic without signs of hypersensitivity. In all cases outcome was favorable with complete recovery between 60 and 120 days. The CIOMS diagnostic scale rated a causal role of tetrabamate as highly probable in six cases and as probable in one.
Conclusion: Tetrabamate can induce hepatotoxicity, probably due to an idiosyncratic metabolic mechanism. Because of this finding and the existence of more appropriate therapeutic alternatives, tetrabamate should not be used in the treatment of alcohol withdrawal.