NEW REZULIN CAUTIONS

Parke-Davis, maker of Rezulin (troglitazone), is revising its prescribing instructions for this diabetes medication, in response to reports of adverse reactions involving hepatic (liver) dysfunction. To ensure the highest degree of patient safety, closer and more frequent monitoring of liver function will be required.

Difficulties experienced by Rezulin users ranged from slightly elevated levels of serum transaminase (in approximately 2 percent of cases), to reversible cases of jaundice, to several cases of permanent liver damage. Of the 800,000+ patients (in the U.S. and Japan) treated with Rezulin since its introduction in early 1997, approximately 150 have developed significant liver complications, and four have died.

It is not time for a panic flight away from the drug, but it is time for increased vigilance. Like most medications, Rezulin has risks, and isn't for everybody—some folks will have idiosyncratic reactions or allergies, and we need to be alert to that possibility. All the major diabetes medications carry risks, and we need to weigh a particular medication's risks against its observable benefits. Rezulin does its intended job very well—and, unless new side effects appear, it is statistically safer than Metformin.

Parke-Davis now recommends that patients who develop nausea, vomiting, abdominal pain, anorexia, dark urine, or other symptoms suggestive of hepatic disorder or jaundice should immediately report those symptoms to their doctor. Rezulin should be discontinued if the doctor finds jaundice, or if laboratory tests suggest liver injury (such as ALT >3x normal). It is recommended that serum transaminase levels be checked at the start of therapy, then every month for the first six months of treatment, and then every other month for the next six months, and periodically thereafter. It is also recommended that liver function tests be ordered promptly at the first symptom suggestive of hepatic dysfunction, as listed above.

Rezulin is a very new drug. As we live with it, we will learn more about what it can do for us, what it cannot, where it is safe, and for whom it is not. The best thing we can do at this time is be cautious, pay attention, get those liver function tests, and communicate promptly with our doctors at the first sign of any difficulties.