Avandia: Legal Information

Avandia (rosiglitazone) 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. GSK also promoted the drug as helping lower cholesterol.

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

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 ultimately paid $3 billion to the federal government to settle claims against the drug company. GSK also paid more than $3 billion to settle individual lawsuits.

In this article, you’ll learn about:

• How Avandia should work and its known side effects
• Some of the health problems this diabetes drug causes
• Legal claims related to Avandia
• What to do if you or a loved one took Avandia and suffered a stroke or heart attack

You’ll also find a reverse chronological timeline of Avandia research and legal updates.

Drug manufacturers have a legal responsibility to ensure their medications carry adequate warnings and are safe to use. If you’ve been harmed by Avandia or another prescription drug, you may have a claim. Contact a product liability attorney near you to share your story and learn about your legal options.

How Does Avandia Work?

The FDA approved Avandia in 1999 as an oral medication that increases insulin sensitivity. The drug makes your body use insulin more efficiently to stabilize blood sugar levels.

Avandia helps your body respond to the insulin your body produces naturally. This, in turn, can help reduce your blood sugar and prevent damage to your kidneys, nerves, vision, and other organs.

Competitors of GSK released a drug called Actos (pioglitazone) that works similarly. The crux of GKS’s marketing and sales practices for Avandia was that it worked better and was safer than Actos. However, 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 its own studies and found that its 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 and posed serious risks to cardiovascular safety. It ultimately demanded that the manufacturer add the black box warning. This warning is still on Avandia’s label today.

Avandia Side Effects

As with most other medications, Avandia has adverse side effects. Some of these include the following:

• Edema (swelling of your hands, feet, and ankles)
• Headaches
• Weight gain
• Abdominal pain
• Vision problems
• Anemia
• Decreased appetite

Unfortunately, many patients have complained that Avandia causes more serious side effects such as heart attack, stroke, and other cardiovascular risks. The drug can be hazardous for people already suffering from heart disease.

As a result, many patients filed lawsuits against the drug company due to heart problems.

Does Avandia Raise the Risk of Heart Attacks?

The active ingredient in Avandia is rosiglitazone, which the FDA has classified as a thiazolidinedione drug. Some medical studies have linked rosiglitazone to an increased risk of heart attack, congestive heart failure, and stroke.

In 2007, the New England Journal of Medicine published a study that found that patients who took Avandia had an increased risk of myocardial infarction (heart attack).

In another study, medical researchers examined elderly patients with type 2 diabetes who took Avandia. They found that patients who took the drug had a higher risk of stroke and heart failure.

But just because there is medical evidence that Avandia may cause stroke and heart attack doesn’t mean you’re automatically entitled to compensation. Your product liability attorney must prove that the drug caused your medical issues. They also must prove that you suffered damages.

FDA Decisions About Avandia Have Changed

In 2011, the U.S. Food and Drug Administration (FDA) announced that it would restrict access and distribution of Avandia and other rosiglitazone drugs. The FDA also ordered the drug manufacturer to add two black box warnings to the medication’s label and packaging. It based its decision on data showing an increased risk of heart attacks in patients who took rosiglitazone drugs.

Under the FDA guidelines, healthcare providers prescribing Avandia must enroll in the “Rosiglitazone Risk Evaluation and Mitigation Strategy (REMS)” program. Only pharmacies that meet special certification requirements can dispense Avandia.

In November 2013, the FDA announced it would rescind its limitations on using and distributing Avandia and other rosiglitazone drugs. The FDA cited a recent study showing that rosiglitazone didn’t have an increased risk of heart attack and death compared with other type 2 diabetes drugs.

Doctors no longer have to register in REMS now that GSK has made labeling changes to the medication. Also, all pharmacies may now distribute Avandia.

Avandia Product Liability Litigation

Thousands of patients have filed Avandia lawsuits against Glaxo. Most plaintiffs in the Avandia cases are patients who took the drug and became sick. Also, 38 state attorneys general have sued the company for defective marketing. The drug company was also criminally fined more than $242 million.

To date, GSK has settled about 700 lawsuits for $60 million. But thousands of cases remain pending in state and federal courts. Many attorneys base these lawsuits on product liability. If successful, plaintiffs may recover damages for:

• Lost wages
• Medical expenses
• Pain and suffering

Under product liability law, pharmaceutical companies, drug manufacturers, and sellers must ensure drug safety. Plaintiffs claim that GlaxoSmithKline provided defective warnings about the risk of heart attack and stroke.

Timeline of Avandia News, Research, and Legal Updates

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, when GSK settled many of its lawsuits.

An FDA advisory panel also lifted the severe restrictions on dispensing the drug. The FDA stated that the drugmaker had to educate physicians about its side effects and 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 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.”

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 alternative 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.

Cardiovascular Problems After Using Avandia? Get Legal Help

If you took the diabetes drug Avandia and developed heart disease or had a stroke or heart attack, you may have a legal claim. The best way to know is to talk to a personal injury lawyer who can review your case and provide expert legal advice. Working with an experienced attorney may help you get the verdict you want for your claim.

FindLaw’s directory of product liability attorneys can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug cases. Many attorneys offer free case evaluations.