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FDA May Have Known About Avandia® Heart Risk

Diabetes Pill, Avandia®, Linked to Heart Attacks

WASHINGTON, DC -- June 1, 2007 -- The diabetes drug Avandia® increased the risk of heart attacks by about 43 percent, according to a recent report from the Cleveland Clinic (N Engl J Med. 2007 May 21). Also, more Avandia® users died from heart-related problems than did patients who used other diabetes medications.

The researchers analyzed 42 studies, related information from the Food and Drug Administration (FDA) web site and a clinical-trials registry maintained by Avandia®'s manufacturer, GlaxoSmithKline. Some clinical trials lasted only 24 to 52 weeks, yet Avandia®'s effects on the heart were seen even with such short-term exposure.

Avandia® and the FDA

In response to the Cleveland study, the Food and Drug Administration (FDA) issued a muted warning to doctors and patients about the safety of the medication (FDA Alert, May 21, 2007). However, some consumer groups believe that the FDA alert is inadequate and comes too late.

Public Citizen points to an internal FDA memo dated July 16, 2002, that highlights concerns about Avandia® and heart disease. At that time, the FDA had 47 reports about heart failure among patients taking Avandia® or a related drug, Actos®. As of last fall, the number had increased to 803 (415, Avandia®; 388, Actos®), according to Public Citizen.

Mindful of the turmoil over the recalled arthritis drug Vioxx®, Congress has begun investigating how closely the FDA monitored Avandia®. Rep. Henry Waxman (D-Los Angeles) has scheduled a hearing of the Committee on Oversight and Government Reform on June 6, 2007, to discuss the FDA's role in evaluating Avandia®'s safety.

How Does Avandia® Work?

Avandia® (rosiglitazone) increases sensitivity to insulin and lowers blood glucose levels in patients with type 2 diabetes. It is in the family of drugs known as thiazolidinediones, which also includes the diabetes drug Actos® (pioglitazone).

Formerly called "adult-onset diabetes," type 2 diabetes accounts for almost 95 percent of all diagnosed cases of diabetes. A person with type 2 diabetes has a pancreas that cannot produce adequate amounts of insulin. This form of diabetes is often associated with older age, increased weight, a family history of diabetes, defective glucose metabolism and physical inactivity (National Diabetes Statistics, NIH).

Your Avandia® Case

Brayton Purcell is reviewing cases of patients who have taken Avandia® and suffered heart attacks. If you have been injured by Avandia®, please feel free to contact us for more information.

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