Avandia Side Effects

As of June 2024, heart attack, congestive heart failure, stroke and coronary artery disease were the most common Avandia (rosiglitazone) side effects reported to the U.S. Food and Drug Administration. These four conditions account for 89.4% of all Avandia adverse events reported to the FDA.

A 2007 article by cardiologist Steven Nissen and Kathy Wolski of the Cleveland Clinic first exposed Avandia’s association with heart-related severe side effects. Other studies have linked the drug to liver failure and an increased risk of pregnancy.

Of the more than 93,000 adverse events reported to the FDA, the agency classifies over 87% as “serious.”

Disclaimer: Reports submitted to the FDA do not necessarily indicate that the drug caused an adverse event. It is important to consult with a healthcare professional before changing your medication.

After Avandia was linked to heart-related side effects, its popularity plummeted. Due to these risks, the FDA temporarily imposed a restricted access program called Risk Evaluation and Mitigation Strategy (REMS) in 2011, severely limiting its prescription.

Other side effects of Avandia include bone fractures, liver toxicity, edema, weight gain, vision problems and unexpected pregnancy risks.

“In my clinical practice, the most worrisome adverse effects of Avandia are congestive heart failure, myocardial infarction and liver problems,” Dr. Michael McKinney, primary physician of the medical weight loss center Healthy Outlook, told Drugwatch.

Manufacturer GlaxoSmithKline allocated billions of dollars to resolve thousands of Avandia lawsuits, alleging that the company concealed the risks of heart attack and cardiac death from the public.

Less common adverse effects may include swelling, hypertension, upper respiratory tract infection, headache, back pain, high blood sugar, fatigue, sinusitis, diarrhea and low blood sugar.

Avandia remains on the market in the United States.

FDA warnings and restrictions on Advandia have fueled the medication’s plummeting popularity. In 2007, the FDA required a black box warning about its potential to cause or worsen congestive heart failure.

The FDA’s REMS that restricted the amount of prescriptions, negative reports and increased medical skepticism drastically reduced Avandia’s use in treating type 2 diabetes.

“The basic plot of the rosiglitazone story quickly became obvious to the advisory committee: a new ‘wonder drug,’ approved prematurely and for the wrong reasons by a weakened and underfunded government agency subjected to pressure from industry, had caused undue harm to patients,” Dr. Clifford J. Rosen, the joint committee chair, wrote in
The New England Journal of Medicine. “The rosiglitazone story thus carries lessons for scientists, practitioners, and regulators alike.”

The FDA discontinued their REMS in 2015 after manufacturers updated the label warnings about heart failure and provided educational training to doctors about its risks. Health professionals must monitor patients for rapid weight gain, breathing issues and swelling.

“I equip my clients with knowledge about the signs of heart failure such as difficulty in breathing and swelling in their lower extremities while stressing the importance of seeking immediate medical attention should any of these symptoms occur,” McKinney said.

Avandia showed an increased incidence of bone fractures in clinical trials, according to the drug’s label.

Long-term trials found increased bone fracture risk in patients taking Avandia, especially women. Unlike typical osteoporosis sites which are in the spine, hips and wrist, fractures caused by Avandia often occur in the upper arm, hand and foot.

This fracture risk persisted beyond the first year of treatment. Patients should monitor and maintain bone health while on Avandia.

In a study published in the
Archives of Internal Medicine, Swiss researchers found that patients with diabetes on thiazolidinediones, the drug class Avandia belongs to, had double the odds of fractures compared to patients who did not use these drugs. Those who took the drugs for over a year had an even higher risk of bone fracture, especially in the hip and wrist. The study compared the records of 1,020 patients with diabetes with fractures against a control group of people with diabetes who did not have fractures.

“This analysis provides further evidence of a possible association between long-term use of [the drugs] and fractures, particularly of the hip and wrist, in patients with diabetes mellitus,” the authors wrote.

Avandia’s label warns of possible liver toxicity and against prescribing it to people with a history of liver problems. It also instructs doctors to check patients’ liver before and while on the drug.

A study in the journal LiverTox concluded that while Avandia is linked to rare instances of liver injury, it has a much lower rate of liver enzyme elevation and clinically apparent liver injury compared to troglitazone — an antidiabetic and anti-inflammatory drug in the same drug class. Most liver issues resolved after stopping the medication, though there have been reports of fatal cases, according to the study.

Another case series in Pharmacoepidemiology & Drug Safety suggested that rosiglitazone and pioglitazone (Actos) may cause liver problems, citing 21 cases of drug-associated liver failure reported to the FDA between 1997 and 2006.

“This is the largest case series of liver failure associated with rosiglitazone or pioglitazone reported to date, strengthening the evidence that these drugs can cause severe hepatotoxicity [liver damage],” the authors wrote.

Doctors should be cautious about continuing treatment in patients with mild liver enzyme elevations and monitor them closely.

Avandia is linked to other potential side effects such as swelling, vision problems, blood and blood sugar effects, increased pregnancy risk, anemia and weight gain, according to a 2022 StatPearls article by Bryan S. Quintanilla Rodriguez and Ricardo Correa.

Because there are many Avandia alternatives, the right treatment for you depends on your heart health, the side effects of each alternative, the cost and insurance coverage, the type of diabetes you have and the effectiveness of each drug.

“I consider alternatives such as metformin, DPP-4 inhibitors, like sitagliptin, or GLP-1 receptor agonists, such as liraglutide, for patients at higher risk of the severe side effects of Avandia,” McKinney told Drugwatch.

“The choice to go for other medication depends on the patient’s total profile, including their cardiovascular risks, kidney functionality and personal choices,” McKinney said.

“Metformin is always my first option because it has an improved safety record compared with other oral agents and clinical outcome trials show that it reduces macrovascular complications in diabetics.”

A frank conversation with your doctor can help them determine your best alternative.

Editor Lindsay Donaldson contributed to this article.