U.S. government scientists found GlaxoSmithKline Plc’s diabetes drug ‘Avandia’ increased heart risks and deaths compared to a rival pill, according to a Food and Drug Administration reviewer who worked on the study. Rosiglitazone is a generic name of Avandia, a commonly used diabetes drug. The study, which has not been published, comes two weeks ahead of a Food and Drug Administration hearing on Avandia’s safety. Also, it has a huge review of Medicare records.

A study first raised concerns about the drug’s cardiovascular effects in 2007. Dr. David Graham, author of the recent paper and a known whistleblower who wants the pill banned, argued in 2007 to an advisory panel of outside experts that Avandia sales should be stopped. A study concluded that people taking Avandia had a 43 percent higher risk of suffering from a heart attack, Avandia was given a black box warning at that time.

Since Avandia came on the market in 1999, as many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be reported as per Graham. According to Graham, harms from Avandia are great enough to “put you in a hospital or in a cemetery”.

The study by Graham and colleagues involved 227,571 Medicare patients, average age 74, who started on Actos or Avandia from July 2006 through June 2009 and were followed for three years on average. They found that Avandia increased the risk of stroke by 27 percent, heart attack by 25 percent and death by as much as 17 percent than those on Actos.

Studies in younger patients implicated that heart attack risks were similar in both groups with Avandia. In older adults, sudden cardiac deaths are much more common and whether Avandia affects heart risks differently in older versus younger patients is unknown.

Graham said that the findings suggest that if 60 people were treated with Avandia for one year, one extra case of heart failure, stroke or death would occur that could have been avoided if they had taken Actos instead of Avandia.

For Type 2 diabetes, the most common form of the disease and the kind often tied to obesity, Avandia is a once-blockbuster drug. In type 2 diabetes, a function of the insulin hormone is decreased. Avandia and Actos are pills that help the body to make better use of insulin.

A statement is issued from the American Heart Association to remind patients not to stop taking any medicine without talking with their doctors first. The statement says that the new study is not definitive enough to prove harm but “deserves serious consideration” and should be discussed between patients and their doctors.

“These are two important papers that will be part of the discussion that F.D.A. has as we consider the important question of Avandia’s safety” said by Dr. Joshua M. Sharfstein, F.D.A.’s principal deputy commissioner.

The British company GlaxoSmithKline PLC, maker of Avandia maintains that its drug is safe. According to spokeswoman, the new study has limitations, and that the company looks forward to a full discussion of evidence at the FDA hearing.

However, Dr. Alvin Powers, a diabetes specialist at Vanderbilt University, called it “important information that’s consistent with prior studies even if it is not definitive”. He doesn’t prescribe Avandia because of uncertainty over its safety.

In hopes of influencing an expert panel, the studies were made public Monday, so the information would be available before the July 13-14 to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market.

An advisory panel will weigh data on the drug at the FDA’s public meeting in July and could offer recommendations ranging from keeping the drug on the market, to calling for further restrictions, to pulling the product altogether.

Nissen, chair of cardiovascular medicine at the Cleveland Clinic said, “A drug that increases the risk of heart attack by a third or more in a diabetic population is truly an enormous public health burden.”

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