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 attorneys 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
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:- Stroke
- Heart failure
- Death from any causes
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.AVANDIA LAWSUITS
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
