Reports of Liver Damage and Rezulin Lead to Revised Use Guidelines
Rezulin has since been removed from the market. This article was posted before Rezulin was removed from the market.
BOSTON — November 24, 1997 — There have been recent reports of severe liver damage in two individuals taking the new type 2 diabetes medication troglitazone (Rezulin). In addition, mild elevations of liver enzymes — suggesting that there may have been some possible irritation to the liver caused by this drug — have been identified through testing in about 2% of people using Rezulin. It has been suggested that people who have these earlier, mild liver function test elevations may be at greater risk of developing severe liver damage. Therefore, in the interest of preventing severe liver problems, liver function tests should be conducted regularly and monitored closely in people using this drug, particularly if these tests have been above normal. Patients should stop taking Rezulin if these elevations become excessive.
The manufacturer and the Food and Drug Administration (FDA) have issued new guidelines for monitoring for liver damage in people using Rezulin. These new recommendations include administering liver function tests during the first month after patients begin taking the drug, as well as screening at three-month intervals during the first year of drug use for signs of liver problems. The drug should be discontinued if the liver enzymes become markedly elevated, or if the patient shows any of the first symptoms of liver dysfunction (nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine).
Physicians at Joslin will continue to prescribe the medication in appropriate cases because the drug is highly effective in lowering blood sugars for some patients. For many of these people, other drugs, including insulin, are either not appropriate or have not achieved the desired levels of glucose control. Joslin physicians will adhere to the manufacturer and FDA recommendations for regular monitoring of liver enzymes and screening for symptoms typical of liver problems.
