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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 Avandias 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.
Drug study links Avandia to heart problems, strokes - Washington Times
Senate report links diabetes drug Avandia to heart attacks - CNN
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 Avandias 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.
Drug study links Avandia to heart problems, strokes - Washington Times
Senate report links diabetes drug Avandia to heart attacks - CNN
where it is sold as Windamet and Windia by GlaxoSmithKline. The generic versions of Rosiglitazone are made by Sun Pharmaceuticals Ltd, Dr Reddys Laboratories Ltd and Torrent Pharmaceuticals Ltd, among 30 other firms. 
just take the case of the drug called Adderall XR which is given to kids "suffering" from ADHD
if someone is taking this drug say a year later the guy dies no one will be able to see the link and the incident will go unrepoted
I used to take it then 
like this cream i bought a few months back for my mom a little googling told me the cream has a chemical that is known to cause internal bleeding a american boy died after using that cream...i could not give it to my mom after that i just threw the cream out of the window--dad was very angry when he found out i have discarded the doctors medicine 
