Avandia is a prescription drug designed to manage blood sugar levels for patients with type 2 diabetes. The medication is made by drug company GlaxoSmithKline. Approved by the U.S. Food and Drug Administration (FDA) in 1999, it wasn’t long before doctors and researchers found there was a serious risk of heart disease for patient taking Avandia.
In 2007 the FDA required that Avandia get a black box warning on all packaging due to the overwhelming evidence that heart failure is a risk of taking the medication. Evidence has also turned up that GlaxoSmithKline knew about this risk years earlier. This has led to numerous lawsuits. In 2013 the company reached a settlement, agreeing to pay $229 million in seven different states.
Avandia and Type 2 Diabetes
Avandia is the brand name for a generic drug called rosiglitazone, a member of the class of medications that are called thiazolidinediones. Avandia was approved by the FDA in 1999 to treat type 2 diabetes. This kind of diabetes occurs in adults whose bodies have become insensitive to insulin, the hormone that controls blood sugar. Avandia works in the body to increase that sensitivity, and therefore, to manage and balance blood sugar levels.
Medications like Avandia are supposed to be used in conjunction with lifestyle changes like a better diet and more exercise. It is not used to treat other types of diabetes, like type 1 diabetes or diabetic ketoacidosis. Avandia does not cure type 2 diabetes. It manages the chronic illness and reduces the risk of developing complications from diabetes, like nerve damage, vision loss, kidney failure, or gum disease. It can take up to two weeks for Avandia to work, and up to three months for a patient to get the maximum benefit.
For many patients taking Avandia is safe and has benefits that outweigh the risks that come with the medication. There are possible side effects, though, which should be reported to the prescribing doctor, especially if they are severe or do not go away. These include back pain, a runny nose, a headache, or a sore throat.
Side effects from Avandia may also be more serious and require immediate medical attention. If you take Avandia and you experience any of these symptoms, contact your doctor right away: nausea, vomiting, stomach cramps, dark urine, lightheadedness, chest pain, yellow skin or eyes, dizziness, swelling in the face or mouth, difficulty breathing or swallowing, fever, hives, vision loss, or pain in the neck, arm, or jaw.
Congestive Heart Failure
The most serious of all possible side effects or complications of taking Avandia is congestive heart failure. The FDA announced in 2007 that evidence from studies concluded that there is an elevated risk that patients could develop heart failure while taking Avandia or of worsening heart failure for those who already have the condition when they started taking the medication.
It was in 2007 that the FDA first required that Avandia carry a black box warning, a type of packaging warning that is reserved for the most serious side effects of a medication. The warning states that Avandia causes or worsens congestive heart failure in some patients. It recommends that patients who have just started the medication or who have just received a dosage increase be monitored carefully for signs of heart failure. It also states that the drug is not indicated for anyone with symptoms of heart failure.
In 2001, just two years after Avandia was approved, the FDA requested that GlaxoSmithKline conduct a study to compare the cardiovascular risks of the drug to similar diabetes medications. The company claimed that the study showed no increased risks compared to other medications, but later it was found that the study was inadequate. In 2004 the New York attorney general sued GlaxoSmithKline over another drug, and the company subsequently agreed to make all of its trial data available online.
In 2007 a cardiologist working at the Cleveland Clinic used that online trial information to analyze the risk of heart failure in patients taking Avandia. He found that patients had a 43 percent increased risk. GlaxoSmithKline tried to persuade the doctor not to publish his findings, but he did publish them in a paper in the New England Journal of Medicine. His paper is what ultimately led to the FDA’s 2007 black box warning and public statement of the risks of taking Avandia.
GlaxoSmithKline’s actions regarding Avandia and the risk of heart failure led to many lawsuits against the company. A hearing in front of the Senate Finance Committee stated that the company knew about the risks years before they became known to the public, that the company hid data, tried to suppress critics of the medication, and promoted sales of Avandia in spite of the known risks. In the meantime, more studies came out highlighting the risk of heart failure in patients taking the drug.
Since the FDA issued the special warning in 2007, several thousand lawsuits have been filed against GlaxoSmithKline. Many of these were consolidated and by 2010, the company had settled most of them for a total in the hundreds of millions. In 2013 the final lawsuits filed by state attorney generals were settled with $229 million more paid out by GlaxoSmithKline. Several more lawsuits are still outstanding including class action suits and a suit brought by the Cherokee Nation.
In spite of the settlements the company has refused to admit any wrongdoing. In official statements a spokesperson claimed that the company acted responsibly in testing and marketing Avandia and in monitoring it for safety and side effects. The company maintains that Avandia does not increase the risk of heart disease, that plaintiffs in lawsuits could not connect Avandia to their heart conditions, and that they never hid data about the medication in trials.
If you took Avandia and have suffered heart problems you think may be related, talk to a lawyer about your options. Although they admit no wrongdoing, it is clear from settlements and independent evidence that GlaxoSmithKline could have done more to protect patients.