Two New Drugs Can Improve Body's Insulin Use

FDA Consumer, Sept, 1999

Two new drugs to treat Type II diabetes have received FDA approval.

Avandia (rosiglitazone) and Actos (pioglitazone) improve the body's ability to use the insulin it naturally produces. The body's resistance to insulin is suspected to be an important underlying cause of Type II diabetes.

Either drug can be used alone or in combination with certain other diabetes drugs. But, while Actos can be used in combination with insulin, Avandia is approved only for patients who are not on insulin.

Avandia and Actos are in the thiazolidinedione class of drugs. This class includes Rezulin (troglitazone), which was recently limited in use following reports of severe liver toxicity and deaths (see accompanying article).

No evidence of liver toxicity was seen in clinical trials of Avandia or Actos. However, because of the liver toxicity problems associated with Rezulin, FDA recommends that patients taking Avandia or Actos undergo liver toxicity tests at the start of therapy, every two months during the first year, and periodically thereafter. Symptoms of liver problems include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, dark urine, or jaundice (yellowish skin and eyes). Patients experiencing any of these should have a liver toxicity test.

Patients taking Avandia or Actos should follow a careful diet and maintain an appropriate weight.

Avandia is made by SmithKline Beecham, Philadelphia. Actos is made by Takeda Chemical Industries, Ltd., and will be co-promoted in the United States by Takeda Pharmaceuticals America, Inc., and Eli Lilly and Co.