Avandia Recent News

Avandia is a Type 2 diabetes medication manufactured by GlaxoSmithKline (GSK). Over the years, the drug company marketed the drug as the safest alternative for patients with Type 2 diabetes. They also promoted the drug as helping lower cholesterol.

There was a problem. Not only was Avandia riskier than other diabetes medications, but it also carried a high risk of heart problems. Glaxo withheld this information from the Food and Drug Administration (FDA). It also buried in-house studies that showed Avandia increased heart problems by a factor of three.

Once patients taking Avandia started reporting heart trouble, the FDA became concerned. After reviewing several studies, the FDA found that the drug significantly hurt patients' heart health. They also determined that the drug manufacturer was not honest when marketing the drug.

Many patients filed lawsuits against the drugmaker. So did the federal government and attorneys general from 46 states. As of early 2024, GSK has settled all outstanding cases. GSK ended up paying $3 billion to the federal government to settle claims against the drug company. Glaxo also paid more than $3 billion to settle individual lawsuits.

Following is a brief timeline of the Avandia litigation. We will also explain what to do if you become sick after taking a dangerous drug.

What Is Avandia?

Avandia is a Type 2 diabetes medication manufactured by GlaxoSmithKline. The FDA approved the drug in 1999 as an oral medication that increases insulin sensitivity. The drug makes your body use insulin more efficiently to stabilize blood sugar levels.

Competitors of GSK released a drug called Actos (pioglitazone) that works similarly. The crux of Glaxo's marketing of Avandia was that it worked better and was safer than Actos. But the drug company did internal studies and found that it wasn't safer than the competitor's drug.

What Did Clinical Studies Reveal?

GSK conducted their own studies and found that their medication was riskier than Actos. GSK hid the results of this study from the FDA to avoid having to put a black box warning on their medicine.

Over time, the FDA learned of these studies and others, confirming that Avandia caused severe heart problems. It ultimately demanded that the manufacturer add the black box warning. This warning is still on the labeling today.

Below is a brief timeline showing Avandia's risks and the ensuing litigation. Concerns over Avandia's safety started in 2007 and continued until 2015. This is when GSK settled many of its lawsuits.

An FDA advisory panel also lifted the severe restrictions on dispensing the drug. The FDA said that the drugmaker had to educate physicians about the side effects of the drug and the cardiovascular risks.

November 14, 2007: Heart Attack Risk Added to Avandia Labeling

Effective November 2007, the FDA required that the diabetes drug Avandia carry a black box warning of increased heart attack risk. The warnings state that studies "have not confirmed or excluded" the risk of heart attack and chest pain associated with Avandia use.

The data available to the FDA didn't show that Avandia was more dangerous than other Type 2 diabetes drugs.

September 12, 2007: JAMA Studies Show Avandia Heart Risk

Two studies in the Journal of the American Medical Association (JAMA) showed that the use of Avandia (rosiglitazone) increased the risk of heart failure. It also suggested that safer medications were available.

August 14, 2007: Avandia to Carry "Black Box" Warning

The U.S. Food and Drug Administration (FDA) announced that several diabetes drugs, including Avandia (rosiglitazone), would carry "black box" warnings for the risk of heart failure associated with the drugs.

The upgraded warning emphasized that the drugs could cause or worsen heart failure in certain patients. The "black box" warning is the FDA's strongest warning. FDA's review of Avandia and its possible increased risk of heart attacks is ongoing.

July 30, 2007: Panel Makes Recommendations on Avandia

An FDA panel recommended that Avandia (rosiglitazone) remain on the market despite evidence that it increased the risk of heart attacks. The panel told the FDA that Avandia's labeling should warn about the increased risk of heart attack.

May 21, 2007: FDA Safety Alert on Avandia

The U.S. Food and Drug Administration (FDA) issued a safety alert for Avandia (rosiglitazone) and its links to heart risks. The FDA issued the alert shortly after a study published in the New England Journal of Medicine (NEJM) suggested a connection between Avandia use and an increased risk of heart disease and heart attack.

The NEJM article concluded that "patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone [Avandia] for Type 2 diabetes." (Read the FDA Safety Alert)

2010: FDA Severely Restricts the Dispensing of Avandia

Given the serious concerns over the drug's safety, the FDA announced that it was restricting the use of Avandia. The European Medicines Agency pulled the drug from the market entirely due to clinical trials in Europe and abroad. The European Medicines Agency did not think there were warnings or restrictions strong enough to protect patients from the risks of the medication.

2012: Generic Versions of Avandia Became Available

GSK's sales of Avandia plummeted following widespread knowledge of the controversy over the drug's health risks. Before 2010, sales of Avandia exceeded $3 billion. By the time the generic became available, Glaxo's sales had dropped to just $680 million.

2012: Avandia Litigation and Criminal Charges Against GSK

Between 2007 and 2012, numerous patients filed lawsuits against GSK. The federal government and various state attorneys general also sued the drug manufacturer. The federal prosecutor's office also criminally charged GSK for false marketing tactics.

The drugmaker resolved the federal and state lawsuits in 2012. The federal cases settled for $3 billion, while cases filed by the attorneys general settled for another $319 million.

2013: FDA Lifts Restrictions

In 2013, GlaxoSmithKline asked the FDA to reevaluate their Type 2 diabetes medication. A special FDA panel conducted a meta-analysis of recent studies on the drug. The FDA also considered a longitudinal study conducted by the Duke Clinical Research Institute. The study showed that Avandia was as safe as alternate medications.

The safety data revealed that Avandia was no more harmful than other diabetes medications, such as metformin and sulfonylurea. So, it lifted the restrictions on the drug. Unfortunately for GSK, it was too little, too late. Sales of Avandia had dipped below acceptable levels.

2015: GSK Settles Outstanding Lawsuits

By 2015, Glaxo had settled the majority of the private lawsuits.