Please be advised that O’Connor, Acciani & Levy are no longer accepting cases for Avandia.
Studies have shown the type 2 diabetes drug Avandia increases the risk of a heart attack and other life-threatening cardiovascular issues, like strokes.
If you suffered cardiovascular health problems or lost a loved one to a heart attack or stroke caused by this medication, you may be entitled to compensation for medical bills, lost wages and various other damages through an Avandia lawsuit. O’Connor, Acciani & Levy’s dangerous drug lawyers can handle every aspect of your case, from the investigation to filing a lawsuit and negotiating for fair compensation. We understand how devastating injuries from a dangerous drug can be and are committed to holding manufacturers accountable for the suffering they have caused.
Our attorneys have decades of experience helping those who were injured by another’s actions, such as people injured by defective drugs. Your consultation with an attorney is 100 percent free and we do not charge legal fees unless you obtain compensation.
AVANDIA SIDE EFFECTS
On May 25, 1999, the U.S. Food and Drug Administration (FDA) approved Avandia (rosiglitazone maleate) for the treatment of type 2 diabetes. Like Invokana, Avandia is a prescription medication that is meant to help people with type 2 diabetes control blood sugar levels. Type 2 diabetes patients tend to have high blood sugar, which puts them at risk for serious injuries, like heart disease and kidney damage.
Avandia quickly became a popular type 2 diabetes medication, eventually reaching a peak of $3 billion in sales. GlaxoSmithKline (GSK), the manufacturer, recorded sales of $1.6 billion in 2006 alone.
However, in 2007, a study came out revealing users of this drug had a 43 percent increased risk of suffering a heart attack compared to those taking other diabetes drugs or a placebo. The study, published in the New England Journal of Medicine, also found an increased risk of death from cardiovascular issues.
Another conclusion from the study was that there was an urgent need to do a comprehensive evaluation of Avandia to determine the risk of cardiovascular problems. Researchers noted that GSK’s disclosure of the results of clinical trials was not sufficient to enable an accurate assessment of cardiovascular risks.
For the study, researchers reviewed more than 40 studies of Avandia involving approximately 28,000 patients.
FDA BLACK BOX WARNING
This study led to the FDA adding a black box warning to the Avandia label. A black box warning is the most serious warning the FDA can add to a drug, indicating there is reasonable evidence the drug can cause severe health problems.
The FDA warning briefly covers the results of the study and notes that Avandia can cause or worsen congestive heart failure in certain patients. When patients start taking this drug, or if their dosage is increased, they should be carefully observed for any signs or symptoms of heart failure, including:
- Excessive or fast weight gain
- Labored breathing
- Swelling/fluid buildup in the feet, ankles or legs
When patients experience these symptoms, doctors should consider discontinuing Avandia or reducing the dosage.
If you suffered heart problems while taking Avandia, contact our attorneys about filing an Avandia lawsuit to pursue fair compensation.
FDA RESTRICTIONS ON AVANDIA
A joint FDA advisory committee considered removing Avandia from the market in 2007, when the black box warning was added to the Avandia label. However, the committee voted 22 to 1 to leave the drug on the market.
Over the next few years, evidence continued to mount about the dangers of Avandia. In early 2010, a government report claimed GSK pressured doctors to withdraw warnings about the drug’s side effects. The report also alleged GSK knew about the risk of heart attack and stroke even before the New England Journal of Medicine study came out.
In June 2010, the Journal of the American Medical Association published a study about Avandia where researchers concluded the drug was associated with a higher risk of the following health issues:
- Heart failure
- Death from any causes
Just one month later, an FDA advisory panel voted on whether or not to keep Avandia on the market. Twelve members of the advisory panel voted to remove the drug from the market, 10 voted for the drug to only be sold with additional warnings or restrictions on its use, seven called for added warnings, three voted for no changes, and one member abstained from voting.
While the FDA is not required to adopt an advisory panel recommendation, the organization typically does. In this case, the FDA decided to leave the drug on the market, with restrictions on its use. Health care professionals and pharmacies could only prescribe, dispense or receive Avandia if they enrolled in the Risk Evaluation and Mitigation Strategy (REMS) program.
The REMS program requires doctors and patients to register and complete paperwork showing they understand the risks of taking the drug. These restrictions caused a tremendous decrease in the number of patients taking Avandia, from approximately 120,000 to just 3,000.
REGULATORS REMOVE AVANDIA RESTRICTIONS
One of the reasons for the added restrictions on prescribing Avandia is that regulators reviewed the results of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial.
The FDA’s original analysis of the RECORD trial was that this drug was more likely to cause heart attacks. However, in 2013, the FDA did another analysis of the results of the trial and came to a different conclusion. Regulators decided that the results were not statistically significant, and it was not clear if the increase in heart attacks for Avandia patients was due to the drug or other factors.
This led the FDA to release another drug safety communication in 2013 announcing restrictions on the sale of Avandia were being removed.
Contact our firm today to find out if you may be able to file an Avandia lawsuit to obtain fair compensation for the injuries you suffered while taking this medication.
There have been more than 50,000 Avandia lawsuits filed in state and federal court since 2007. That year, federal Avandia lawsuits were consolidated into a Multidistrict Litigation (MDL) in the U.S. District Court for the Eastern District of Pennsylvania.
These cases make various allegations against GSK, including that the company:
- Failed to adequately warn patients and doctors about the dangers of Avandia
- Concealed information about the risks of the drug from consumers and medical professionals
- Misrepresented the safety of this medication in marketing and advertising of the drug
Many Avandia lawsuits are still pending, but thousands have been resolved through settlements, including approximately 5,300 from the MDL.
There were multiple settlements in 2010, including a $60 million settlement of 700 lawsuits and a $460 million settlement of 10,000 cases. Another 5,500 cases were settled in 2011 for $250 million. These were cases involving patients who died because of Avandia side effects.
GSK has also reached settlements with the federal government and dozens of state governments. In 2012, the drug manufacturer pled guilty to federal charges that it did not report clinical data on Avandia and unlawfully promoted two other drugs for uses that were not on the label. The company agreed to a $3 billion settlement with the U.S. Department of Justice.
GSK was also sued by 38 state attorneys general for presenting Avandia as a cholesterol-lowering medication and promoting its cardiovascular benefits, even though it may have increased cardiovascular risks. This led to a $90 million settlement that was divided up among the 38 states in November 2012.
Our experienced attorneys can meet with you in a free, no obligation legal consultation to determine if you have grounds for an Avandia lawsuit. We are committed to working to hold GSK accountable for failing to warn you about the risks and other forms of negligence.
SCHEDULE A FREE, NO OBLIGATION LEGAL CONSULTATION TODAY
When a prescription medication puts patients at risk of death or potentially life-changing injuries, the manufacturer could be held liable for medical expenses and other damages through an Avandia lawsuit.
The trusted defective drug lawyers at our firm know how to build a strong case against negligent drug manufacturers and pursue the compensation our clients deserve.
At O’Connor, Acciani & Levy, we take cases on a contingency fee basis. This means your consultation is free of charge and you will not owe us legal fees unless you receive compensation.