Rosiglitazone (marketed under the trade name Avandia) is an antidiabetic drug that is used for the treatment of patients with type 2 diabetes. It is one of several antidiabetic drugs sold in the United States—along with Avandamet, Avandaryl, and metformin with sulfonylurea. While the U.S. Food and Drug Administration (FDA) withdrew warning requirements regarding a potential link between Avandia and cardiovascular issues—including heart attacks—in 2018, a new study gives rise to new concerns.
After FDA Reversal, Independent Study Confirms Increased Risk of Heart Problems Associated with Avandia
Avandia has a long and complicated history when it comes to the drug’s link to cardiovascular issues. While Avandia had previously been linked to an increase in heart attacks and cardiovascular issues among patients in the 2000s, in 2018 the FDA determined that:
“[R]ecent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea.”
Notably, however, this did not mean that the FDA had ruled out a link between Avandia and cardiovascular issues. Rather, it meant that the current data (at the time) were inconclusive as far as whether patients who took Avandia were at increased risk compared to patients who received other type 2 diabetes medications. The FDA made this clear, stating, “it is not clear whether the risk of death, heart attack, and stroke were truly different between rosiglitazone [Avandia] and metformin plus sulfonylurea.”
Basically, this was a win for Avandia’s manufacturer, GlaxoSmithKline—a win for which the manufacturer no doubt fought hard and spent millions of dollars. With the FDA’s decision, GlaxoSmithKline was no longer required to include additional warnings on Avandia’s labeling, and health care providers were no longer advised to avoid prescribing Avandia when possible. However, while the data may have been inconclusive on a broad scale, there was still anecdotal evidence suggesting a link between Avandia and cardiovascular complications.
This led to continued study of Avandia’s effects; and, in 2020, researchers concluded that Avandia still presents cause for concern. In an article discussing the findings, Everyday Health quoted the lead researcher as stating, “Numerous studies have found that Avandia use is associated with an increased cardiovascular risk, especially for heart failure.” Acknowledging that, “the effect of Avandia on (heart attacks) has been more uncertain,” the researchers found that:
“[I]ndividuals taking Avandia were 33 percent more likely to have a heart attack, heart failure, or death from heart problems or other causes. When researchers looked at each of these risks separately, they found the strongest and most worrisome evidence for heart failure: a 54 percent greater risk of this developing in people taking Avandia.”
While Avandia is now only rarely prescribed in the United States, it remains available, and many patients who were prescribed Avandia in the past—including after the FDA’s reversal in 2018—faced risks as a result of receiving this potentially-dangerous drug. Among those patients who suffered cardiovascular issues after taking Avandia, many remain eligible to pursue claims, and many families who have lost loved ones to heart failure caused by Avandia remain eligible to pursue wrongful death claims as well.
Pursuing a Dangerous Drug or Wrongful Death Claim Related to Avandia
Patients who have been diagnosed with cardiovascular conditions and families who have lost loved ones due to heart failure caused by Avandia potentially have multiple options for pursuing claims. For example, depending on the circumstances involved, patients and families may have claims for:
- Drug Defects – Drug defect claims are governed by the law of strict liability. Even if GlaxoSmithKline was unaware of the heart risks associated with Avandia (which may or may not have been the case), it can still be held liable for heart attacks, heart failures and other cardiovascular issues caused by the drug.
- Drug Manufacturer Negligence – If GlaxoSmithKline knew, or should have known, of the cardiovascular risks associated with Avandia, then continuing to market and sell the drug could expose the company to liability for negligence. While it isn’t yet clear what happened with regard to Avandia, it is not unusual for drug companies to attempt to conceal information about risks associated with their products.
- Medical Malpractice – Given that there are alternative treatments for patients with type 2 diabetes available, health care providers who prescribed Avandia to patients unnecessarily could potentially be liable for medical malpractice.
Regardless of which type of claim you (or your family) can file, taking action promptly is the best way to protect your legal rights. You should schedule an appointment to speak with an attorney, and you should take some steps to make sure you get the most out of your free initial consultation. For example, it will be helpful if you can:
- Collect all medical records related to your (or your loved one’s) Avandia prescription;
- Collect all medical records related to your (or your loved one’s) cardiovascular diagnosis after taking Avandia; and,
- Write down as many details as you can remember, including the approximate date on which you (or your loved one) received Avandia when the cardiovascular complications began, and the health care providers involved.
Serious and fatal cardiovascular issues can lead to substantial costs for patients and their families. Drug manufacturers like GlaxoSmithKline deserve to be held accountable for putting dangerous drugs on the market, and health care providers deserve to be held accountable when they fail to take adequate precautions. If you have a claim for cardiovascular issues linked to Avandia, you may be entitled to significant financial compensation, and you will want to work with an experienced attorney to recover the financial compensation you deserve.
Schedule a Free Consultation about Your Avandia Claim Today
If you would like to know more about pursuing a legal claim for a heart attack, heart failure or other cardiovascular issue linked to Avandia, we encourage you to get in touch. To schedule a free, no-obligation consultation with an experienced lawyer at Searcy Denney, please call 800-780-8607 or tell us how we can reach you online today.