Diabetes Information: Why Was Rezulin Approved?
May 16, 2001
Rezulin, Warner-Lambert's drug for Type II diabetes, was first submitted to the FDA for review in 1996. Certain FDA investigators, including Dr. John L. Gueriguian, questioned Rezulin's effectiveness in controlling blood sugar levels. However, more troubling to Dr. Gueriguian were the deadly side effects that the drug may cause, including liver and heart damage. When Dr. Gueriguian expressed his concerns to his superiors at the FDA he was promptly removed from the investigation of Rezulin.
After only six months of study, the FDA approved Rezulin in 1997, despite well-documented safety problems. Warner-Lambert believed Rezulin could be a billion dollar blockbuster drug. With such high economic stakes riding on new drugs, it is no surprise, some observers say, that the FDA feels great political pressure to expedite the approval process and perhaps even turn a blind eye to troublesome side effects.
Only six months after Rezulin's approval in January 1997, hundreds of patients taking the new drug had been admitted to the hospital, some with severe cases of liver failure. The FDA's reaction? Change Rezulin's label to warn patients and doctors of liver complications and recommend constant liver monitoring. British officials took more drastic action; Rezulin was quickly banned in that country after British medical officials determined that the drug was simply too dangerous, with or without a change in the label.
While the political powers that be at the FDA found the label changes to be sufficient, their FDA research colleagues felt otherwise. In March 1999 FDA scientist Dr. David J. Graham called Rezulin one of the most dangerous drugs on the market. Dr. Graham felt that even vigilant liver monitoring was not enough to protect patient safety. He cited three patients who had been closely monitored by their doctors, yet suffered liver failure causing at least one of them to die.
Even after more label changes, deaths and serious liver complications associated with Rezulin use continued to mount. In March 2000, after over 60 Rezulin related deaths, the FDA finally relented and announced the recall of the drug. A mere three months later almost 400 deaths had been linked to Rezulin. When one considers that the FDA typically only hears about 10% of all drug related problems, Rezulin deaths could easily reach into the several thousands.
While liver failures received the most attention during the Rezulin episode, medical experts wonder what effect the drug may have played on the heart. As a condition of Rezulin's 1997 approval, the FDA asked Warner-Lambert to conduct a post-approval study of the drug's effect on the heart. Warner-Lambert never completed the study. Such post-approval studies are often required of drug manufacturers as part of their "stage 4" clinical trial. Stage 4 trials refer to research conducted after a drug is on the market. Like Rezulin, many drugs are approved on the condition that the manufacturer complete one or more of these post-approval studies. Recently it has come to light that many of these companies simply do not follow through with such studies.
-- Article Courtesy of InjuryBoard.com
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