The last week of July had the Internet quite active with reports of how Glaxo SmithKline's blockbuster drug Avandia (rosiglitazone) and Eli Lilly/Takeda's Actos (pioglitazone) were being held responsible for a slew of side effects – right from bone fractures to fatal heart attacks.

It is probably the first time in several months after Merck’s Vioxx trials that a drug has generated a heated debate in markets across the globe.

However, a federal advisory panel that met in the US to review studies of the drug said that the drug should remain on the market, but with stronger heart risk warnings.

The committee concluded that the evidence is suggestive of an increased heart disease risk associated with its use, but that the evidence is not sufficiently strong to remove the drug from the market and also that the benefits of the drug far outweighs its risks.

The panel said that certain groups should not take the drug because their risks are even higher. That includes people taking nitrates, such as nitroglycerin, to ease pain from angina, and those taking insulin for their Type 2 diabetes.

“Physicians will have to think twice before they prescribe the drug for these people,” said the panel’s chair, Dr Clifford Rosen of the Maine Center for Osteoporosis.

“I am very satisfied the committee voted to put a strong warning on the drug,” said Steven Nissen, the head of cardiology at the Cleveland Clinic and author of the May study linking Avandia to a 43 percent increased risk of heart attacks. “This will allow patients and physicians to make decisions based on more information than we had,” he said.

Earlier, the debate on the drug had reached a new high with a senior drug safety scientist urging the US Food and Drug Administration (FDA) for the removal of Avandia from the market.

There is “no evidence of major clinical health benefits” from Avandia and leaving it on the market may “cost thousands of lives,” said David Graham, a Food and Drug Administration safety scientist at a meeting in Gaithersburg, Maryland.

In his slides that were presented at the meeting, Graham questioned Avandia’s health benefits compared with other treatments. Graham’s recommendation doesn’t represent the FDA’s position and he has disagreed with his superiors in the past and was one of the principal architects to pull out Merck & Co’s painkiller Vioxx from the market on the grounds of heart risks.

The findings on Avanida are based on a meta-analysis of more than 78,000 patients, which estimates that one in every 50 patients taking the drugs over a 26-month period will require hospital admission due to heart failure. “This means that the diabetes drugs could have caused thousands of additional cases of heart failure, creating a substantial burden on hard-pressed health services,” said Dr Yoon Loke, a clinical pharmacologist at UEA’s School of Medicine, Health Policy and Practice. The results are published in the August edition of the journal Diabetes Care.

Although doctors have been aware of the side effects of the drug, the can of worms was probably opened in May this year when a leading US cardiologist published evidence of the drug's link to heart attacks and death in an article in the New England Journal of Medicine.

In an analysis of 42 trials, Nissen found that use of rosiglitazone raises patients’ risk of heart attack and cardiovascular death by 43 per cent and 64 per cent, respectively, in comparison to the use of a placebo or other anti-diabetic therapies.
Until the findings were made public, the drugs were two of the most commonly used by diabetics - largely belonging to the overweight category and also those who had an aversion to insulin pricks.

In the same month, the FDA issued a safety alert on the drug. Among other things the alert suggested that the FDA was aware of a potential safety issue related to Avandia. It also concluded that Av