Two cases have been reported of liver damage in patients taking rosiglitazone, a thiazolidinedione oral antidiabetic agent (Annals of Internal Medicine 2000;132:118 and 121). Both reports concerned male patients in their 60s who developed liver toxicity soon after beginning treatment with rosiglitazone. The first patient was taking three to four paracetamol tablets a day (and had previously used higher doses) and had "a remote history of alcoholism". The second case involved a man with heart failure. He had also been taking a number of drugs, including pravastatin and verapamil that the authors acknowledge can cause hepatitis. Both sets of authors suggest that liver enzyme levels are monitored frequently in patients taking rosiglitazone, particularly when therapy is initiated, and say that the drug should be discontinued immediately if levels become raised.
In a letter published in the same issue (Ibid, p164), Smithkline Beecham, the US manufacturer of rosiglitazone, comments that three independent hepatologists have conducted a review of the second patient's medical records. Their conclusion was that the pattern and time course of the biochemical abnormalities was characteristic of ischaemic hepatitis and was not characteristic of hepatotoxicity as previously seen with troglitazone, the first drug in this class. The company says that reports of liver abnormality did not differ from placebo in its rosiglitazone clinical trial programme. The letter does not comment on the other case.
Last October, the European Committee for Proprietary Medicinal Products which advises the European licensing authority, turned down a licence application for rosiglitazone (PJ 1999;263:702).