Doctors Ignored FDA Warnings on Drug

The August 15, 2001 issue of the Journal of the American Medical Association published a letter from Dr. David Graham and his colleagues at the U.S. Food and Drug Administration (FDA). The authors concluded that many doctors ignored FDA letters warning them of dangerous reactions to the recently banned diabetes drug Rezulin.

Four separate letters, from the drug company that produced Rezulin, were sent to U.S. doctors at the request of the FDA warning them of dangerous liver damage that was occurring in patients taking the drug. The letters recommended continuous monitoring of liver enzymes to determine if liver damage was occurring. According to Dr. Graham, the letters and extensive publicity "did not result in sustained or meaningful improvement in the performance of liver enzyme testing of patients taking the drug."

"Labeling changes and warning letters to physicians cannot be relied upon to effect changes in the way Related Web Sites medicine is practiced,'' Graham said.

He went on to say that "even if monthly 1 and type 2 testing had been performed in all patients, it may well have had little effect in terms of preventing acute symptoms associated liver failure with [Rezulin]."