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October 6, 2010 at 4:00 PMComments: 0 Faves: 0

FDA to Regulate Rosiglitazone

By Smarty More Blogs by This Author

Diabetes patients have been prescribed specific medications in order to control the symptoms associated with their condition. Among the drugs being prescribed were Avandia, Avandaryl, and Avandamet. Recently, extensive studies were done to test the danger and effectiveness of these drugs because they contain a questionable ingredient: rosiglitazone. The risks proved to be too significant and concerns were elevated, causing the U.S. Food and Drug Administration (FDA) to announce the substantial restriction of rosiglitazone in medications.

What is Rosiglitazone?

Rosiglitazone is a thiazolidinedione antidiabetic agent that is intended to assist glycemic control in adults with type 2 diabetes mellitus. Typically, it is only used for patients with an illness that cannot be controlled by other medications. Diet and exercise are recommended with the use of rosiglitazone to improve its effectiveness. As with many prescribed medications, there is the possibility of negative side effects with rosiglitazone. They alarmingly include an increased risk of death from cardiovascular damage.

The Case Against Rosiglitazone

In 2007, medical researchers began conducting clinical trials on rosiglitazone. The results revealed the risk of myocardial infarction (heart attack) and death when rosiglitazone was used, in comparison to standard diabetes drugs or a placebo. Since the risk of death by cardiovascular causes was near-significant, it was enough to raise the doubts about rosiglitazone for the researchers. Following a review of the trials, the FDA proceeded to add more information on the labels of products with rosiglitazone. This took place in July, 2007 and the labels updated the warnings with new information about the ischemic cardiovascular risk. Sponsors were also required to test the safety of rosiglitazone against another anti-diabetes drug, pioglitazone. The second meeting of the FDA about rosiglitazone was held approximately three years later. After carefully reviewing the data, regulatory actions were put in place to protect patients from the drug's potentially lethal side effects. Drug sponsors are now required to submit a Risk Evaluation and Mitigation Strategy (REMS). Basically, this restricts the use of rosiglitazone to patients that could not improve glycemic control with other medications, have consulted with their doctor, and are unable to take pioglitazone for medical reasons. Existing users of rosiglitazone will be allowed to continue using it if the drug has shown positive results for them and they indicate that they understand the risks associated with it. Patients currently taking rosiglitazone will review the dangers of rosiglitazone as part of their eligibility requirements. The regulations were based on the FDA's conclusion that pioglitazone did not show a cardiovascular ischemic risk and that there is in fact a significant cardiovascular ischemic risk with rosiglitazone.

The Rosiglitazone Controversy

People both in and out of the medical profession have started the debate about rosiglitazone and what should be done to limit its use. One idea was to again update the labels and make the threat of rosiglitazone use clearer. However, the FDA was not convinced that the labels would be read by everyone, which prompted them to issue regulations instead. Some think that the FDA's regulations have gone too far, while others have the opinion that not enough has been done and that rosiglitazone should be taken completely off the market. For now, rosiglitazone will continue to be marketed under the specific rules and guidelines of the FDA. Although the regulations did not remove rosiglitazone, they are designed to lower its use considerably.


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