Avandia Warning Label To Change

Two days of hearings by the advisory committee of the FDA recommended that the type 2 diabetes drug Avandia (Rosigliatzone), stay on the market, with the addition of a label to include increased warnings.  Rosiglitazone is a drug in a class of drugs called thiazolidinediones which are slated to treat type 2 diabetes.

With a vote of 20 to 12 the panel recommended the trial, requested by the FDA to evaluate the long-term treatment with this drug, continue.  The trial was designed to study the long-term effects of treatment on cardiovascular effects in comparison to a placebo.  It is also directed to study the effects of long-term supplementation of Vitamin D on cancer and mortality.

Based on the results of the trial that is underway, the FDA will make a final decision on whether the risks of Avandia outweigh the benefits experienced by the type 2 diabetes patients who take the medication.  The most serious consequences for patients diagnosed with type 2 diabetes are heart disease and stroke.  There are also several other steps that patients can take to lower their likelihood of consequences.  Prevention should be focused around lifestyle changes such as not smoking, diet and physical activity.  It is also imperative to keep blood sugar stable and blood pressure down.  Sometimes the addition of low-dose aspirin therapy is warranted.

Although Avandia has shown to have some significant benefits for those who take it, the FDA must determine if making other changes could be just as effective without the additional risks that Avandia can impose.

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