Avandia Drug

A widely prescribed drug to treat Type 2 diabetes substantially increases the risk of heart attacks and death from cardiovascular disease, according to a study released today that critics say questions the government's ability to monitor drug safety. Patients who took Avandia to reduce their blood sugar levels were 43% more likely to have a heart attack than patients who were given other medications or a placebo.

Federal investigators warned nearly five years ago that the diabetes drug Avandia might be causing heart failure, according to an internal government memo released Tuesday by a consumer group. Investigators also raised concerns about Actos, a similar drug used to treat Type 2 diabetes.

GlaxoSmithKline's chief executive said there was an overreaction to a study linking the company's diabetes drug Avandia to heart attacks and predicted the firm would not be unduly damaged. Jean-Pierre Garnier told shareholders during the European company's annual meeting that sales might be affected , but that a careful evaluation of all the evidence should reaffirm the true value of the medicine.

On the eve of a crucial congressional hearing, the makers of the widely prescribed diabetes drug Avandia launched a high-stakes effort Tuesday to refute evidence that their product increases the risk of heart attacks and death. Drug maker GlaxoSmithKline said interim results from a large ongoing clinical trial found no significant difference in heart-related hospitalizations or deaths between patients taking Avandia and those on older medications for Type 2 diabetes.

The government is seeking its strongest safety warning for Avandia and Actos -- two drugs widely used to treat Type 2 diabetes -- amid heightened concern that heart failure risks associated with the medications are poorly understood, officials said Wednesday. The disclosure by Food and Drug Administration Commissioner Andrew C. von Eschenbach came during a House hearing on the agency's oversight of Avandia.

Two large government-sponsored clinical studies involving a widely prescribed diabetes drug that has been linked to heart attacks will be allowed to continue, the National Institutes of Health announced. The agency said safety officers had reviewed clinical data from the two studies involving Avandia and "found no evidence" to require discontinuing use of the drug. However, patients who signed up for the studies will be allowed to switch to other medications if they request.

The widely used diabetes drug Avandia increases the chance of serious heart problems, including a 30% to 40% higher risk of myocardial ischemia, or decreased flow of blood to the heart, according to documents released by the Food and Drug Administration on Thursday. Diabetics taking the GlaxoSmithKline drug in combination with insulin were at even greater risk, the FDA found in a review of dozens of drug studies.

The widely used diabetes drug Avandia should remain on the market because its benefits outweigh the risks, but it should carry a strong warning about an increased risk of heart disease, a federal advisory panel said Monday. The committee concluded that the evidence suggests an increased heart disease risk is associated with its use, but that the evidence is not sufficiently strong to require the drug's removal from the market.

When a major medical journal raised questions about heart risks from a leading diabetes drug earlier this year, many patients began avoiding the drug. But concern turned to dismay when news emerged that both the Food and Drug Administration and the manufacturer had also picked up worrisome signals about the drug -- but had not sounded an alarm, pending further study. Today, the drug, Avandia, remains controversial.

The first major head-to-head study comparing the newer diabetes drug Avandia with the older medicines metformin and glyburide shows that Avandia provides better glucose control than metformin, but carries more serious side effects and a higher cost, researchers said Monday. "Metformin is still the first drug of choice" for newly diagnosed Type 2 diabetics, said Dr. Steven E. Kahn of the University of Washington and the Veterans Affairs Puget Sound Health Care System, who led the study.