FRIDAY, May 25, 2007 (HealthDay News) -- The news that the popular diabetes drug Avandia may increase the risk of heart attack is being met with concern, but not alarm, by health-care professionals.
"We think people should speak to their physician. We don't feel this is an emergency situation," said Dr. Sue Kirkman, vice president of clinical affairs for the American Diabetes Association. "The study was concerning, but the numbers were very, very small -- about an additional one per 1,000."
"People should definitely not panic, and they should talk to their doctors," added Dr. Mary Ann Banerji, professor of medicine at SUNY Downstate Medical Center in New York City.
Rachel Villarreal, a health educator with the Diabetes Education Program in the Texas A&M Health Science Center Coastal Bend Health Education Center, said, "Patients should consult their health-care provider and determine if the risks outweigh the benefits, because there are a lot of benefits to Avandia."
"Don't just take yourself off the medication," Villarreal added. "If you don't feel comfortable taking it, there are other treatment options that are similar."
Those reactions rolled in as a U.S. senator said Thursday that the Food and Drug Administration had been aware for some time of the heart risks posed by the drug. But the FDA said there's no conclusive proof that the risks of Avandia outweigh its benefits.
Still, not panicking and taking a deep breath seemed to be the prevailing expert opinion regarding research published in the June 14 issue of the New England Journal of Medicine that found that Avandia -- an oral medication with the generic name rosiglitazone -- increases users' risk for heart attack by 43 percent. The journal's editors released the findings on Monday because of their public health importance.
An editorial published in the May 26 issue of The Lancet advocated "a calmer and more considered approach to the safety of rosiglitazone," which is made by the pharmaceutical firm GlaxoSmithKline.
The U.S. Food and Drug Administration responded to the study findings by issuing a safety alert Monday for the drug, but stopped short of a stronger warning label, saying more analysis was needed.
"At this point, we have not reached a definitive conclusion on the data," Dr. Robert J. Meyer, director of FDA's Office of Drug Evaluation II, said at the time. "We don't feel there is consistent enough data to make a decision from a regulatory standpoint. We are not ready to make an action."
The FDA also pointed out that, while some data indicated a risk for heart attack with Avandia, other published and unpublished studies showed just the opposite.
On Thursday, Sen. Charles Grassley said the FDA's own preliminary research on Avandia confirmed the heart risks reported in the New England Journal of Medicine study. The FDA findings suggested that as many as 60,000 to 100,000 heart attacks might be linked to use of the drug, which came on the market eight years ago, the Iowa Republican said, according to the Associated Press.
In a statement read on the Senate floor that was placed in the official record, Grassley also said that safety watchdogs at the FDA recommended "several months ago" that a "black-box warning" -- the strongest possible warning -- be placed on the drug, the news service said.
FDA spokeswoman Julie Zawisza confirmed Thursday the existence of the internal analysis that Grassley's statement revealed. But she added that "we have conflicting data" from individual studies, and therefore "are continuing to review the results of [GlaxoSmithKline's] ongoing trial to determine the actual risk," the AP reported.
The authors of the New England Journal of Medicine study, Dr. Steven E. Nissen and Kathy Wolski of the Cleveland Clinic, acknowledged limitations with their study. Nissen, a cardiologist, earlier uncovered cardiac problems with muraglitazar, a drug in the same class as Avandia. He was also an early critic of the arthritis drug Vioxx, which was pulled from the market in 2004 after studies showed it increased the risk of heart attack and stroke.
"Realistically, the data [on Avandia] is not that strong, and everyone is busy reevaluating the primary data from which this is drawn," Banerji said. "We will know much more in the next few weeks."
For the new study, Nissen and Wolski evaluated 42 studies that compared patients taking Avandia with patients not using the drug, which is used to regulate insulin and blood sugar in people with type 2 diabetes. The studies included almost 28,000 patients, 15,560 of whom were taking Avandia.
The study found that the risk of a heart attack was increased 43 percent among those taking Avandia, and there was a 64 percent greater risk of dying from cardiovascular causes.
GlaxoSmithKline responded by issuing a press release Monday defending the safety of the drug. Company officials said GSK "strongly disagrees with the conclusions reached in the New England Journal of Medicine article, which are based on incomplete evidence and a methodology that the author admits has significant limitations."
More than 2 million people worldwide take Avandia for type 2 diabetes, generating $3.2 billion in annual sales for GlaxoSmithKline, according to published reports. The drug was first approved for the treatment of type 2 diabetes in 1999.
"Avandia is very widely used because it affects one of the fundamental problems of diabetes, which is insulin resistance," Banerji said. "It increases the ability of insulin, which is a good thing."
And it's possible that the drug can continue to be widely used.
"Every patient is different. Every patient has different levels of risk for cardiovascular disease. Every patient has differences in terms of what medications might be an alternative," Kirkman said. "That's why we're recommending talking to a health-care provider that knows you and knows your case. We certainly don't want to see people just stopping their medication outright because of this concern."
"If you discontinue using the drug, what will you do?" Banerji asked. "I wouldn't jump from the frying pan into the fire. I would not panic. Keep going with it, if it's doing well."
More information
There's much more on type 2 diabetes at the American Diabetes Association.
