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New diabetes medication should carry
warning about competitor Posted 5-3-99 By Richard A. Marini In an unusual move, a Food and Drug Administration (FDA) advisory panel has recommended that the label of a powerful new diabetes drug should include a warning about possible liver problems linked to a potential competitor. The new drug, Actos (pioglitazone), has been found safe in clinical trials. However, Actos is in the same class of drugs as Rezulin (troglitazone), which has been linked to 28 deaths due to liver failure. The recommended label for Actos will serve to remind physicians and warn patients of that link. Actos and Rezulin are both thiazolidinediones, or TZDs. They work by helping insulin to control blood sugar and are intended for patients with Type 2, or adult onset, diabetes. But while clinical trials of Actos showed only a 0.39 percent increase in liver enzymes—a sign of liver damage—trials of Rezulin showed a 1.9 percent increase. Another FDA advisory panel recently recommended that Rezulin’s label warn that the drug should be used only in combination with other diabetes drugs, such as insulin. It also called for more frequent liver monitoring of patients taking the drug. The panel that made the more recent Actos recommendation took "a very conservative approach," according to Roberta L. Schneider, MD, vice president of drug development for Takeda America Research and Development Center, an arm of the Japan-based Takeda Pharmaceuticals. Takeda has an agreement with Eli Lilly & Co. to market Actos in the United States. Schneider said that a panel of liver experts assembled by Takeda to review clinical trials of Actos found no evidence that it causes damage and did not see the need for regular screenings of patients taking the drug. Schneider said that the FDA is expected
to approve Actos by mid-July and that the labeling
question should be resolved before that. Related Sites |