Rezulin – Facts and History

Rezulin was initially approved for patients with type two diabetes and insulin resistance. Particularly those patients that had not responded as well to oral medications existing at the time. This drug was meant to target insulin resistance, the condition in patients with type two diabetes that results in abnormally high levels of sugar in the blood. The active ingredient in Rezulin, troglitazone, had been shown to help improve sugar levels in patients who had not achieved good results with insulin therapy alone. In fact, researchers were quite optimistic when some patients taking Rezulin were able to forego insulin injections completely.

The manufacturers of Rezulin were forced to add an additional warning on the medication packaging, after numerous reports of severe liver injuries in patients taking this drug. About half a million patients in the United States alone had already been treated with this drug, and about a fifth of those had been taking it for an extended period of time. After one patient was in need of a liver transplant from liver failure and another died from severe liver complications, the drug was held responsible. While detailed research had not been done, Rezulin was considered an important factor in these liver problems. Due to this, initially the Food and Drug Administration recommended taking extra care to check enzyme levels in the liver during the period in which the patient underwent therapy with Rezulin. Further research showed that about two percent of patients taking Rezulin had some kind of liver problem due to abnormal enzyme levels.

After this initial warning by the Food and Drug Administration, there followed a series of warnings of increasing strength on the use of this drug. After several years of having to continually change the warnings on the packaging and issuing warnings for medical professionals, the manufacturers of Rezulin decided to voluntarily retire Rezulin, or troglitazone, from the market. While they declared to the press that the benefits this drug has on insulin sensitivity is quite outstanding and that it far outweighs the risk of liver disease, it would be more practical for everyone involved to look into alternative medications for treating type two diabetes. The company responsible for Rezulin, Warner-Lambert, worked with medical professionals and the Food and Drug Administration in making sure that patients taking Rezulin could switch safely to other alternative medications with as few problems as possible.

It was the view of Warner-Lambert and of many people in the Food and Drug Administration that Rezulin was an efficient and safe drug, or at least comparable to many other similar medications. However, they blamed sensationalistic media coverage of the different warnings issued about this drug for the fear instilled in the general public. With such a climate of disinformation being fostered at the time, the company felt that it was unreasonable and counterproductive to continue marketing this medication. However, the official position has always been that Rezulin is an effective diabetes treatment as long as the patients and the medical professionals involved are allowed to discuss the possible risks and benefits with all the information at hand.

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