Problems Continue for the Diabetic Drug Avandia

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The New York Times has uncovered a confidential government report that recommends that the anti-diabetes drug Avandia (rosiglitazone) be removed from the market because of link to heart attacks and heart failure.

The FDA report, authored by Dr. David Graham and Dr. Kate Gelperin, indicate that Avandia, manufactured by GlaxoSmithKline, was linked to 304 deaths in the third quarter of 2009 in a review conducted by the Institute for Safe Medication Practice. They suggest that if diabetic patients now taking Avandia were instead given a similar medication called Actos (Takeda), about 500 heart attacks and 300 cases of heart failure could be avoided each month. Actos has been shown to lower blood sugar as well as Avandia, without the heart risks.

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Avandia is an oral medication for Type 2 diabetes in a class called thiazolidinediones. It works by increasing the body’s sensitivity to insulin. It is usually taken once or twice a day.

The trouble began in 2007 when a study by a Cleveland Clinic cardiologist linked the drug with harming the heart. The FDA responded by issuing a warning, but did not remove Avandia from the market at that time. More studies have been conducted, but according to Dr. Janet Woodcock, director of the FDA drug center, “there are multiple conflicting opinions” about Avandia.

GlaxoSmithKline has responded by saying that Avandia has been studied extensively and that the scientific evidence does not establish a link between the medication and an increased risk of heart attack. Despite this, the package insert for Avandia contains a significant list of warnings.

  • Rosiglitazone has been shown to increase fluid retention that can lead to or worsen congestive heart failure. Avandia is not recommended for patients with congestive heart failure
  • Some studies have shown that rosiglitazone may increase the risk of angina (chest pain), heart attack , or other problems caused by a decreased blood flow to the heart. This is especially true when Avandia is given in conjunction with insulin therapy.
  • Other clinical studies have shown that women who take rosiglitazone experienced more fractures, especially of the hands, arms, feet, ankles, and lower legs. Men were not shown to be at risk. This has also been shown in patients taking Actos.
  • Physicians should check liver enzyme levels before the initiation of therapy with Avandia and periodically during treatment. Signs of liver dysfunction include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, and dark urine.
  • Macular edema has been reported in some patients taking thiazolidinediones. Patients who have blurred vision or decreased visual acuity should have an eye exam from a ophthalmologist.
  • A decrease in hemoglobin and hematocrit may occur because of increased blood volume.

Patients taking Avandia should talk to their doctor, especially if they experience signs of cardiovascular disease, such as chest pressure, swelling in the arms or feet, rapid weight gain, dyspnea (trouble breathing), signs of liver dysfunction, or inadequate control of blood sugar.

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