The diabetes drug Avandia has been associated with a significantly higher incidence of heart attacks and death, according to a major research analysis.
Avandia, generically rosiglitazone and made by GlaxoSmithKline, was found to have a 43 percent greater risk of heart attack and a 64 percent increased risk of heart-related death.
The U.S. Food and Drug Administration issued a “black box” warning for Avandia in 2007 and FDA officials more recently were reported calling for its removal from the market.
The New York Times cited confidential government data in reporting that Avandia was linked to 304 deaths during the third quarter of 2009.
If you or someone you love suffered a heart attack or related death potentially associated with the use of Avandia, you may want to contact an Avandia attorney.
The latest findings concerning Avandia and the risk of heart attack and death were the result of an analysis of 42 studies involving 15,560 patients who took Avandia and 12,283 who took other drugs or were given a placebo. The study was conducted by doctors at the renowned Cleveland Clinic and reported May 21, 2007 in The New England Journal of Medicine. (Read Article.)
One of those who conducted the latest study, Steven Nissen, chairman of cardiology at the Cleveland Clinic, said it raised “serious concerns about the cardiovascular safety” of Avandia. (He advised that patients first consult with their doctor before discontinuing use of the medication.) The study was of particular concern since Avandia is taken by a patient population already prone to heart disease.
Following release of the study, termed a "meta-analysis," the FDA issued the following warning: "Safety data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia." The FDA said its own analysis of the drug was ongoing.
In addition, Congressional investigators were looking into what they termed “very serious” claims that Glaxo “silenced one or more medical professionals who attempted to speak out about the potential for cardiovascular problems with Avandia.”
According to a report in The New York Times, one early critic of Avandia, Dr. John B. Buse, was “intimidated” by the drug company. As early as 2000, Dr. Buse, a diabetes specialist charged in a letter to the FDA that Glaxo had used “blatant selective manipulation of data” to overstate the benefits of Avandia and to understate its risks.
Avandia, prescribed in pill form, is the most widely used oral diabetes treatment, with 2006 sales of $3 billion. It was approved in 1999 for the treatment of Type 2 diabetes – the most common form of diabetes -- and has since been taken by more than six million people worldwide.
Some 21 million people in the United States suffer with diabetes. It occurs when the body does not produce enough of the hormone insulin or does not effectively use insulin to convert blood sugar into energy.
Kline & Specter, PC, with more than 35 experienced attorneys, several of whom are also highly regarded doctors, is one of the nation's leading law firms with the ability to litigate pharmaceutical drug lawsuits. Contact an Avandia lawyer today
Avandia News
- Tom Kline quoted on Avandia litigation, The Legal Intelligencer 1/19/11
- More than three years of thiazolidinedione monotherapy for diabetes was associated with a 40% increase in relative risk of myocardial infarction and a 29% increase in relative risk of death, researchers here found.
- Avandia, a drug used by millions of diabetes patients, may contribute to bone loss, according to a new study conducted in mice.(Full story)
- Poll shows that 61 percent believe the FDA should have been tougher in ordering "black box" warning for the Avandia label.
- GlaxoSmithKline P.L.C.'s once popular diabetes drug Avandia received the government's strongest warning - a black-box label - yesterday, indicating that users may face a small but increased chance of heart attacks.(Full story)
- The FDA ordered today that a myocardial infarction warning be added to the black box warning on the rosiglitazone Avandia label.
- Diabetes patients treated with rosiglitazone (Avandia) did no better than those treated with other drugs, according to a Cochrane systematic review.
- Plaintiffs build case against diabetes drug (Full story)
- Tom Kline interviewed on diabetes drug Avandia (See video )
- Doctor Says Avandia Maker Intimidated Him After Raising Issue of Heart Risk, 'I Was Characterized as a Liar,' He Tells a House Committee. (Full story)
- F.D.A. Calls for New Warnings on Diabetes Drugs.(Full story)
- Diabetes Drug Still has Risks, Doctors Warn.(Full story)
- Cardiovascular safety trial of rosiglitazone found no significant increase in myocardial infarction or cardiac death, but suggested an increased risk of heart failure.
- Doctor Says Drug Maker Tried to Quash His Criticism of Avandia .(Full story)
