There's a growing concern about potential liver toxicity in diabetics using Rezulin (troglitazone).
Rezulin has been given to over half a million patients since it came out early last year.
But now there are over 150 reports of possible liver dysfunction...resulting in one liver transplant and several deaths.
Now experts are sorting through the evidence. Glaxo recently took Rezulin off the market in Great Britain...but our FDA thinks the benefit is worth the risk.
Recommend regular liver function tests for Rezulin patients. Get a baseline test, then recheck once a month for 6 months...every other month for the next 6 months...and then periodically.
Tell patients to report symptoms of liver problems...jaundice, nausea, abdominal pain, fatigue, dark urine, etc.
Report any cases to the FDA MedWatch program at 800-FDA-1088. This will help determine the frequency of this problem.
FDA Talk Paper 11/3/97, 12/1/97.FDC Reports 1997;59(45):7. WSJ 12/2/97.