Avandia or rosiglitazone is an oral diabetes drug approved to treat type 2 diabetes. The disease is thought to affect 18 to 20 million Americans at this time. Type 2 diabetes is one of the so-called lifestyle diseases. Complications include coronary heart disease, blindness, kidney failure and limb amputation

Avandia won approval from the FDA in 1999 to treat people suffering from type 2 diabetes. The approval was based on clinical trials, which showed the drug was very useful in reducing blood sugar levels in people suffering from the condition.

Over 2 million people worldwide use Avandia to control their blood sugar levels. The drug manufactured by GlaxoSmithKline has annual sales turnover of $3.2 billion. In such a scenario, the new study questions if the drug should even be prescribed to diabetics at all.

Below are some questions and answers regarding the new study and the FDA alert on Avandia.

What does the new study say?
The study is a Meta analysis of previous studies on Avandia. It says that people taking the drug have a 64 percent chance of dying from heart complications. Additionally Avandia also raised the risk of suffering a heart attack by 43 percent.

What are the details of the study?
The study was conducted by Dr. Steven Nissen and Kathy Wolski at the Cleveland Clinic. They reviewed 42 previous studies on Avandia involving 28,000 patients. Among them 15,560 were taking Avandia, while the rest were on placebos.

The researchers said 86 people taking Avandia had heart attacks compared with 72 people taking a placebo. Furthermore some 39 people taking the drug died from heart complications, while 22 patients not receiving the drug also died from cardiovascular causes.

How has the American Diabetes Association reacted to the study?
The ADA has said the findings of the review were "somewhat concerning." However Dr. Sue Kirkman, vice president for clinical affairs at the association said people should not panic and consult their doctors first before stopping the drug.

What does the FDA safety alert say?
The FDA received the data from Glaxo on the heart risk of Avandia in August 2006. The agency decided to issue a safety alert following the early release of the NEJM study.

Dr. Robert J. Meyer, director of FDA's Office of Drug Evaluation II, said the data in the study was inconclusive and hence the FDA did not feel the need to take any action.

However the agency recommended that vulnerable patients should examine other options as well. "Patients who are taking Avandia, especially those who are known to have underlying heart disease or who are at high risk of heart attack should talk to their doctor about this new information as they evaluate the available treatment options for their type 2 diabetes," it said.

But the FDA also cautioned it does not have enough data to judge on the heart risks of Avandia. "FDA has not confirmed the significance of the reported increased risk in the context of other studies," Meyer said. "Further, the FDA doesn't know whether other approved treatments in the same class of drugs have the same or greater risks."

How have experts reacted to the study?
In an accompanying editorial, Bruce M. Psaty, of the University of Washington, and Curt D. Furberg, of Wake Forest University, say the study means patients no longer have a good reason for continuing Avandia.

"In view of the potential cardiovascular risks and in the absence of evidence of other health advantages, except for laboratory measures of glycemic [blood sugar] control, the rationale for prescribing rosiglitazone at this time is unclear," they wrote.

What is Glaxo's reaction to the study?
GlaxoSmithKline said its own meta-analysis had proved Avandia increased heart risks by 30 percent. However the British dug giant said long-term observational data was lacking for it to make any conclusions.

"Long-term trials have not shown evidence of a risk at all and our observational studies have not shown any evidence that there is an excess of myocardial ischemic events in patients being treated with Avandia," the company's Chief Medical Officer Ron Krall said.

A statement by the company also said the data was incomplete. "Data from ADOPT showed that the overall risk of serious, cardiovascular events [CV death, myocardial infarction, and stroke, or MACE endpoint] for patients on Avandia was comparable to metformin and sulfonylurea (glyburide) -- two of the most commonly used medicines to treat type 2 diabetes," it added.

What should diabetics do?
Type 2 diabetes sufferers taking Avandia need not panic. However if they have pre-existing heart conditions, then they should talk to their doctors and discuss other options available to them.