Avandia linked to health woes
Source: Agencies |
June 29, 2010, Tuesday
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Print Edition
Print Edition
A NEW study led by a US federal drug safety expert ties the controversial diabetes drug Avandia to a higher risk of heart problems, strokes and deaths in older adults, and says it is more dangerous than a rival drug, Actos.
The study, a huge review of records from the federal health care program for the elderly, comes two weeks ahead of a Food and Drug Administration hearing on Avandia's safety. The lead author, Dr David Graham, is an FDA scientist who wants the pill banned.
As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it hit the market in 1999, Graham said.
Avandia can "put you in a hospital or in a cemetery," he said.
Editors at the Journal of the American Medical Association rushed to release the study online yesterday, so the information would be available before the July 13-14 hearing, a spokeswoman said.
Avandia is a once-blockbuster drug for Type 2 diabetes, the most common form of the disease and the kind often tied to obesity. Avandia and Actos are pills that help the body make better use of insulin, a key digestive hormone.
Avandia has been under a cloud since May 2007, when a review of dozens of studies suggested it may raise the risk of heart attacks and heart-related deaths. Warnings were added to its label, and the American Diabetes Association told patients to avoid using it until safety questions were resolved.
The FDA and Congress have held meetings on the drug but it has remained on the market. Hundreds of thousands of Americans still use the drug.
Avandia's maker, Britain-based GlaxoSmithKline PLC, maintains the drug is safe. A spokeswoman said the new study has limitations, and that the company looks forward to a full discussion at the FDA hearing.
The study 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.
Avandia patients were 27 percent more likely to suffer strokes, 25 percent more likely to develop heart failure and 14 percent more likely to die than those on Actos, researchers found.
The study, a huge review of records from the federal health care program for the elderly, comes two weeks ahead of a Food and Drug Administration hearing on Avandia's safety. The lead author, Dr David Graham, is an FDA scientist who wants the pill banned.
As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it hit the market in 1999, Graham said.
Avandia can "put you in a hospital or in a cemetery," he said.
Editors at the Journal of the American Medical Association rushed to release the study online yesterday, so the information would be available before the July 13-14 hearing, a spokeswoman said.
Avandia is a once-blockbuster drug for Type 2 diabetes, the most common form of the disease and the kind often tied to obesity. Avandia and Actos are pills that help the body make better use of insulin, a key digestive hormone.
Avandia has been under a cloud since May 2007, when a review of dozens of studies suggested it may raise the risk of heart attacks and heart-related deaths. Warnings were added to its label, and the American Diabetes Association told patients to avoid using it until safety questions were resolved.
The FDA and Congress have held meetings on the drug but it has remained on the market. Hundreds of thousands of Americans still use the drug.
Avandia's maker, Britain-based GlaxoSmithKline PLC, maintains the drug is safe. A spokeswoman said the new study has limitations, and that the company looks forward to a full discussion at the FDA hearing.
The study 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.
Avandia patients were 27 percent more likely to suffer strokes, 25 percent more likely to develop heart failure and 14 percent more likely to die than those on Actos, researchers found.
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