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The European agency that evaluates medicine has said it will review the safety of the diabetes drug Avandia following research suggesting it is linked to a higher risk of heart problems, strokes and deaths in older adults.
The European Medicines Agency said the review will be conducted by its Committee for Medicinal Products for Human Use when it meets from July 19 to July 22. Depending on the outcome, marketing authorization for the drug in Europe could be revoked or changed.
The US Food and Drug Administration will hold hearings on Avandia, also known as rosiglitazone and made by GlaxoSmithKline PLC, on Tuesday and Wednesday.
“GSK is fully committed to patient safety and believes that rosiglitazone is an important treatment option for appropriate Type 2 diabetes patients,” said Dr. Tony Hoos, European medical director for GlaxoSmithKline.
“It is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients,” he said. He said patients should not stop taking the drug without consulting their doctors.
GSK shares were down 1.3 percent at 1,127 pence ($17.10) in late-morning trading on the London Stock Exchange.
The European Medicines Agency said the drug was authorized for use but with warnings about prescribing for patients with heart failure or a history of heart failure, or to patients with heart problems.
Two years ago, the European committee, known as CHMP, concluded that the drug “retained a small, if diminishing, place in diabetes Type 2 therapy.”
A study published in the United States last month linked Avandia to a higher risk of heart problems, strokes and deaths in older adults, and called it more dangerous than a rival drug, Actos.
As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia since it came on the market in 1999, said Dr. David Graham, lead author of the study and a scientist for the FDA. He wants the pill banned.
Copyright Press Association 2010