Avandia, generic name rosiglitazone, is a drug that was created by GlaxoSmithKline and approved in the U.S. by the Food and Drug Administration (FDA) in 1999 to treat type 2 diabetes. After being on the market for nearly eight years the FDA warned the public that Avandia came with serious risks, including heart disease that could lead to fatalities.
There is now evidence that GlaxoSmithKline knew about the risks of heart attack and heart failure side effects of using this medication. The company may have known about the risks years before the warning became official from the FDA. While lowering blood sugar in patients with type 2 diabetes is important, the risk of having a heart attack because of the drug is not acceptable. The drug maker has had to pay for this unfortunate side effect as people filed lawsuits over it.
Avandia for Type 2 Diabetes
Avandia, or rosiglitazone, is one of many drugs designed to lower and manage high blood sugar levels in patients with type 2 diabetes. This is a chronic condition that more and more people are struggling with in the U.S. High blood sugar can lead to all kinds of long-term complications like heart disease, nerve damage, and blindness, among many others. Controlling blood sugar is essential, and as the incidence of the disease has risen, drug companies have answered with more medications.
The FDA approved Avandia in 1999 to be used along with diet and exercise to control blood sugar. It works by increasing the body’s sensitivity to insulin. This is the natural hormone excreted by the pancreas to lower blood sugar levels and to which people with type 2 diabetes have grown insensitive. Eating better, exercising, and losing weight help patients to turn this disease around, but some doctors prescribe medications like Avandia as well because many people struggle with making these positive lifestyle changes.
Using a medication to control blood sugar in people with type 2 diabetes does not come without risks. For many patients it is a supplement to lifestyle changes that helps lower blood sugar more quickly than diet and exercise alone could do. Side effects are tolerable for these patients and a small price to pay for being healthier. For others the side effects may be more severe, or even life threatening.
The most common side effects of Avandia are not considered serious and for many people are worth the benefits of the drug. The side effects include back pain, a sore throat, a runny nose, a headache, and other cold- or flu-like symptoms.
Less common are some side effects that can indicate a serious problem: edema, or fluid retention and swelling, vision problems, shortness of breath, nausea and vomiting, a fast heartbeat, and yellow eyes or skin, which can indicate liver damage.
Heart Attack and Heart Failure
The most serious of all potential Avandia side effects is the risk of heart disease. In particular, Avandia is known to increase the risk of congestive heart failure and to worsen cases of existing heart failure. The warning about this possibility was only made official by the FDA in 2007, years after Avandia had been in use and putting patients with heart failure at risk of dying.
The 2007 warning also came with the requirement that Avandia packaging include a black box warning. This is the FDA’s most serious warning for a medication side effect, reserved for those that are most severe or potentially life-threatening. Patients taking Avandia should be monitored for signs of heart failure and it is not recommended to be used in patients who already have congestive heart failure.
Avandia is also known to increase the risk of having a heart attack, which can be fatal as well. Clinical studies have shown that the risk is increased by 43 percent in patients using Avandia as compared to control groups. As with the risk of heart failure, this information was only made public in the official announcement in 2007.
What GlaxoSmithKline Knew About Avandia Side Effects
Most people tolerate Avandia well and only ever experience the mild side effects. However, the side effects that can lead to fatalities have affected too many patients. People have died from a heart attack or heart failure while taking the drug, and many believe that GlaxoSmithKline could have prevented these deaths. The company has been accused of knowing of the risk well before 2007 and evidence backs up that accusation.
In 2001 the FDA required that GlaxoSmithKline conduct a study that would investigate the risk of heart-related side effects. The company concluded that the risk was not significantly increased, but later that conclusion was found to be invalid because the study was not conducted well. It wasn’t until 2004 that the company finally made the trial data public.
With that published information a cardiologist from the Cleveland Clinic found that Avandia did significantly increase the risk of heart failure and heart attacks in patients. GlaxoSmithKline then tried to bury those findings, but the information was published and it led to the FDA’s 2007 black box warning.
Over the course of a decade, GlaxoSmithKline tried to hide the serious Avandia side effects of heart attack and heart failure. It had evidence of this risk and that Avandia was no more effective than certain other type 2 diabetes medications, including Actos. The attempted cover up was discovered through a New York Times investigation. Since that information came to light, more research has confirmed that Avandia increases the risk of heart disease.
Side Effects Lead to Lawsuits
The terrible potential side effects of Avandia, as well as GlaxoSmithKline’s cover up of information, has led to a number of lawsuits against the company. The Senate Finance Committee even held a hearing over the actions the company took to hide data and promote Avandia in spite of knowing about the risks it poses to patients. Individuals have also filed lawsuits against the company, some who were harmed by the medication, and others because they lost loved ones to it.
Ultimately, GlaxoSmithKline has paid hundreds of millions of dollars in settlement fees. Most recently it settled a number of cases brought by state attorneys general for $229 million in 2013. Although it has paid so much in settlements the company has never admitted to any wrongdoing and insists that Avandia is safe and effective. If you were hurt because of taking Avandia and either suffered yourself or lost a loved one to heart disease, you may want to find out if you still have time to file a lawsuit. Let a lawyer advise you and help you decide what you can do next.