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.

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.

The two new studies appearing in the latest issue of the Journal of American Medical Association find that Avandia does increase the risk of heart attacks to the tune of 43 percent.

The first study by researchers at Wake Forest University School of Medicine in Winston-Salem, was a review of previous studies involving over 14,000 people. Researchers found that Avandia increased the risk of heart attack by 42 percent and doubled the risk of heart failure. However they did not find increased death rates from cardio vascular causes as had been found by a previous study.

For the second study, lead researcher Michael Lincoff of the Cleveland Clinic and colleagues reviewed 19 studies involving more than 16,000 participants. This study examined any links between Actos (pioglitazone) and the risk of heart attacks.

Actos is a diabetes drug in the same class as Avandia. The researchers found that Actos also raised users' risk for heart failure by 40 percent. But the drug lowered the risk of heart attack, stroke or death from cardiovascular causes by more than 18 percent.

Actos' manufacturer, Takeda Pharma funded the study, but was not involved in collating the results, the authors acknowledged.

In May the FDA issued a safety alert on Avandia following the publication of an article questioning the drug's safety profile. The study was posted on the web site of the New England Journal of Medicine ahead of print on June 14. It said Avandia had the potential to increase a person's risk of heart attacks and even death.

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 placebo.

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.

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.

However many experts as well as Glaxo said the study was a meta-analysis or a review of other studies and the results were hence unreliable.

GlaxoSmithKline mounted a massive PR exercise aimed at rescuing its star drug from the quagmire it finds itself in. Glaxo's problem is compounded by the fact that Takeda's Actos is very similar to its Avandia and patients could easily migrate to Actos.

The company has again disputed the findings of the new JAMA studies. "Patients taking Actos to control blood sugar might be expected to have fewer cardiovascular events than those who were not controlled on medication," the company said in a statement noting that the analysis compared Actos to a placebo and not other drugs.

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

Experts said that Avandia had no obvious benefits over other diabetes drugs available on the market. In the wake of the new study they recommended that type 2 diabetes sufferers move to other available drugs. However they agreed more studies were needed to verify these findings.

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 more specifically Actos.