Diabetes Drug Tied to Heart Risks
By MARILYNN MARCHIONE
A new analysis Monday reported the widely prescribed diabetes drug Avandia is linked to a greater risk of heart attack and possibly death.
More than 6 million people worldwide have taken the drug sold by London-based GlaxoSmithKline PLC since it came on the market eight years ago. Pooled results of dozens of studies revealed a 45 percent higher risk of heart attack, according to the analysis published online by the New England Journal of Medicine.
In a conference call Monday, Glaxo’s chief of diabetes drug development, Dr. Lawson McCartney, said the analysis is not definitive scientific proof. The company is not seeing "anything like" the risks reported in the medical journal, he said.
"We remain very confident in the safety and of course in the efficacy of Avandia as an important diabetic medicine," McCartney said.
The U.S. Food and Drug Administration had no immediate comment on Monday’s New England Journal report on Avandia.
The company’s stock was down 7 percent in morning trading after the medical journal’s report appeared.
The report on the risks of the diabetes drug follow Glaxo’s $2.5 million settlement of a lawsuit filed by former New York Attorney General Eliot Spitzer over the release of data on the safety and effectiveness of its drugs. Spitzer, now New York governor, accused Glaxo of fraudulently withholding some results of studies that had examined the safety of prescribing the antidepressant Paxil to children.
GlaxoSmithKline disputed that it attempted to mislead anyone, and said it has always been in favor of widespread disclosure of clinical trial results.
Avandia is used to treat Type 2 diabetes, the most common form of the disease, which is linked to obesity. This form of diabetes occurs when the body does not make enough insulin or cannot effectively use what it manages to produce.
Avandia helps sensitize the body to insulin and was considered a breakthrough medication for blood-sugar control.
Several experts said Avandia was another Vioxx-like example of the U.S. government failing to detect a safety problem until after millions of people had taken a drug. Vioxx was a blockbuster arthritis medicine until it was withdrawn in 2004 when heart problems came to light.