Update Regarding Rezulin (Troglitazone): American Diabetes Association Statement

March 21, 2000

New York (MedscapeWire) Mar 21 — The American Diabetes Association has learned through news coverage about continued allegations of the safety and efficacy of Rezulin (troglitazone). Rezulin is an oral medication for the treatment of type 2 diabetes. It is manufactured by Parke-Davis, a division of the Warner Lambert Company. Without having full knowledge of the facts surrounding the allegations, the American Diabetes Association encourages the Food and Drug Administration to provide full disclosure and take the most appropriate course of action.

At this time, the American Diabetes Association does not believe — based on publicly available research data — that the safety concerns regarding Rezulin extend to the other two medications which are in the same class of diabetes drugs as Rezulin. These other two medications include (1) Avandia (rosiglitazone), which is marketed by SmithKline Beecham Pharmaceuticals and (2) Actos (pioglitazone hydrochloride), which is manufactured by Takeda Pharmaceuticals America, Inc. and copromoted by Eli Lilly and Company. All three of these drugs are in a class called thiazolidinediones. Some people refer to this class as the "glitazones" or "insulin sensitizers."

Based on publicly available research data, the American Diabetes Association continues to believe that this class of drugs is beneficial and delivers unique benefits in reducing blood glucose levels in people with diabetes, thereby contributing to the prevention and delay of the serious consequences of diabetes. As with all diabetes medications and devices, this class of drugs will need further monitoring and research to ensure its long-term safety and efficacy.

It is important to note that, if you have any concerns regarding your diabetes medications, the American Diabetes Association strongly encourages you to work closely with your health care team to address these concerns and to help decide the best treatment option for you. The American Diabetes Association emphasizes that you should NOT make any medication decisions without the help of your health care team.