Just weeks before the Food and Drug Administration was to hold a hearing on the diabetes drug Avandia, a study of its health risks in older adults said the drug increases the risk of heart attacks and strokes.
The study was made available online Monday by the editors at the Journal of the American Medical Association, so that it would be released to the public before the July 13-14 FDA hearing.
Dr. David Graham, lead author of the study and senior drug-safety researcher at the FDA, would like to see the diabetes pill banned. His review of Medicare records found those who used the drug experienced increases in heart-related problems, strokes and fatal coronary events.
As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may have been caused by the drug since it came on the market in 1999, Dr. Graham said in an interview with the Associated Press.
The highly popular drug is used for people with Type 2 diabetes, the less severe and more common form of the disease, which is most often linked to obesity. For Type 2 diabetics, either the body does not produce enough insulin or the cells ignore the insulin. A key digestive hormone, insulin is necessary for the body to be able to use glucose for energy.
Avandia and Actos are both pills that help make up for the lack of insulin in the body.
Warnings were added to Avandia’s label in 2007, after earlier studies showed heart attacks and heart-related deaths pointed to the drug as a risk. The American Diabetes Association strongly encouraged patients to avoid taking the drug until these safety questions were resolved.
“The American Diabetes Association just follows FDA regulations and has no position on this matter,” an ADA spokeswoman said.
The American Heart Association did not respond to numerous requests for comment, but issued a statement saying that the new study “deserves serious consideration” by doctors and patients.
The maker of Avandia, the British company GlaxoSmithKline PLC, stands firm in its belief that the drug is safe. The new study has limitations, a GlaxoSmithKline spokeswoman said, adding the company looks forward to a full discussion and examination of the evidence at the FDA hearing.
According to its online statement, across the extensive data set for Avandia, there is no consistent or systematic evidence that Avandia increases the risk of heart attack or cardiovascular death in comparison with other anti-diabetes medicines.
But, in the Medicare study, Dr. Graham said the findings suggested that if 60 people were taking Avandia for a year, an extra case of heart failure, stroke or death would occur that could have been avoided if the patients had taken Actos instead.
“The evidence is overwhelming,” he said. “There is not a single study where those two drugs are compared where Avandia doesn’t look worse than Actos. How many studies do you have to do before you come to your senses?”
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