Letters to physicians from the Food and Drug Administration (FDA) and warning labels included with the type 2 diabetes medication Rezulin did little to persuade doctors to routinely evaluate liver enzyme levels in patients taking the medication, according to the results of a study conducted by the FDA.
Rezulin (troglitazone) was approved by the FDA in January 1997 for treatment of type 2 diabetes. After several reports of liver failure associated with the drug, its manufacturer sent four separate letters to US doctors urging them to monitor liver toxicity in their patients on troglitazone by testing their liver enzyme levels.
The drug was pulled from the market in March 2000, after 94 reports of liver failure associated with its use.
An analysis of claims data involving 7,603 patients taking Rezulin who belonged to a large multi-state healthcare organization found that liver enzyme monitoring was infrequently and irregularly performed despite repeated FDA regulatory interventions.
Extensive publicity and repeated warnings about liver failure risk with (Rezulin), including four direct mailings to US physicians, did not result in sustained or meaningful improvement in the performance of liver enzyme testing of patients taking the drug.
Researchers found that testing of liver enzymes before patients began taking the drug rose from 15% of the patients before physician notification to nearly 45% after the four letters. However, less than 5% of patients received all recommended liver enzyme tests after the third month of continuous use of the drug.
The FDA concluded labeling changes and warning letters to physicians cannot be relied upon to effect changes in the way medicine is practiced.
Nevertheless, Graham noted that "even if monthly testing had been performed in all patients, it may well have had little effect in terms of preventing acute liver failure with troglitazone."
JAMA August 15, 2001;286:831-833
Well, we don't need to worry about this particular drug anymore, as it was already pulled off the market. However, the central issue, as the JAMA article points out quite nicely, is that you do need to be concerned that your regular medical doctor will be performing the testing that is recommended by the studies to keep you safe.
While the testing is no assurance that the drug will not harm you, it may offer some level of protection.
The amazing observation, though, is that even after FOUR LETTERS from the Food and Drug Administration (FDA), less than half of the physicians did any of the testing that was recommended. And, overall, only one in 20 did ALL of the recommended testing.
This is especially tragic as well over 95 percent of type 2 diabetes can be controlled by a proper diet and exercise.
If this observation does not tell you that the system is fatally flawed, what will?
If you haven't done so already, I am urging you to get your friends and relatives on board and have them sign up for the newsletter so they can keep up to date on all that the conventional medical community has in store for them.
Together, we can all make a major difference and change this insane paradigm.
Rezulin Taken Off MarketPublic Citizen Urges Tougher Warnings for Diabet