Launched in the U.S. in 1997, Rezulin was the first of the thiazolidinediones or glitazones that help boost the effects of insulin and was seen as new hope for some diabetes patients. Approved in just six months on the FDA’s “fast track” Rezulin raised many serious concerns prior to its approval. The FDA required Rezulin’s label be changed four times up until the Rezulin recall on March 21, 2000. This FDA method has been widely criticized, especially since the doctors themselves do not even read the fine print warnings that drugs like Rezulin contained.

At an FDA advisory committee meeting a cardiologist and director of Duke University’s Clinical Research Center estimated that less than 1% of physicians have seen a label in the last year. Dr. Sidney Wolfe thinks that cases like Rezulin show that the FDA should ban drugs faster because warnings do not work. FDA critics find it hard to believe that a leaflet contained information warning Rezulin patients that it might kill them or seriously injure them.

Jerry Avorn, chief of the division that tracks adverse medication events at the Brigham and Women’s Hospital in Boston, thought Rezulin diabetes drugs looked so dangerous that him and his colleagues advised diabetes doctors at their hospital to stop prescribing it a year before Warner-Lambert pulled it from the shelves due to the FDA’s urging requests. Avorn said,
“I’m astonished that the additional year of product life even existed,” speaking of Rezulin’s prolonged life on the U.S. market (USA Today, 5-3-00).

A day after Rezulin was withdrawn, Public Citizen’s Sidney Wolfe charged that Health and Human Services Secretary Donna Shalala to enforce the 1958 Code of Ethics for Government Service to “put loyalty to the highest moral principles and to country above loyalty to persons, party or Government department.” Rezulin was the fourth drug taken off the market in 1997, a record for any approval year. More specifically Wolfe mentioned the two FDA medical officers that were called to an internal affairs committee because they opposed the continuation of the marketing of Rezulin.

A 1998 survey by Public Citizen found that there was 27 instances in which a medical officer felt a drug should not be approved but was despite their resistance. It was also found that FDA doctors were cited 14 times when told not to present negative data about a drug at an FDA advisory committee meeting.

Sidney Wolfe also found that the FDA could require manufacturers to conduct phase IV studies as a condition of approval. According to a Public Citizen report at least one phase IV study was required for 195 of the 306 new drugs approved by the FDA during the 1990s, but just 11 of the 195 Phase IV studies had been completed. After the FDA approval of Rezulin, officials had negotiated a nonbonding pledge from Warner-Lambert to start a new study to assess Rezulin’s effect on patients who had preexisting heart disease evidence. Few patients were enrolled, and this study was never completed. Rezulin patients did die of heart failure, but doctors claimed many of these patients had preexisting heart problems.

Serious, life-threatening Rezulin side effects have been directly linked to the use of the diabetes drug. Warner-Lambert has been blamed in dozens of deaths from life failure and thousands of other liver damage cases from 1997-2000.