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If you suffer from Type 2 diabetes, your doctor may have prescribed you a medicine called Onglyza. Onglyza was designed to help diabetics by lowering glucose levels (blood sugar) and reducing complications that diabetics suffer. Unfortunately, while very effective at what it does, Onglyza can also cause serious harm to your body—including heart failure and even death.
If you or someone you loved experienced heart problems after taking Onglyza, you are not alone. The makers of Onglyza did not warn patients of the dangers, and you be entitled to a financial recovery. John Foy & Associates is one of the largest and most experienced medical injury law firms in the country. We always represent the patient, never big corporations. Call us at 404-400-4000 and get a free consultation today.
How does Onglyza work?
Onglyza is the brand name for saxagliptin. It’s manufactured by AstraZeneca, a pharmaceutical company, and has been available since 2009. Onglyza was marketed specifically to adults with Type 2 diabetes, who experience spikes in blood sugar after meals or high blood sugar in the mornings. These spikes are caused by the pancreas not producing enough natural insulin (to process blood sugar), the liver releasing too much blood sugar in the first place, or the body not using insulin properly. The spikes are among the most dangerous times for a diabetic, and the times when excess blood sugar can harm the body.
Onglyza is part of a group of drugs known as DPP-4 inhibitors. According to AstraZeneca, the drug works by enhancing the production of insulin in the pancreas and reducing the amount of blood sugar released by the liver, both overnight and after meals.
Why is Onglyza so dangerous?
From early on, Onglyza was known to have a variety of side effects:
- Urinary tract infection
- Respiratory infection
- Low blood sugar, especially when combined with other diabetes medications
Later, a connection with extreme joint pain was also discovered. But none of these side effects were thought to be life-threatening for a typical patient. While uncomfortable, many patients accepted them as a reasonable downside for a medicine that helps control blood sugar. They believed Onglyza was safe.
But Onglyza has a much more serious complication that patients were not warned of. We now know that Onglyza can dramatically increase the risk of congestive heart failure. This condition can be fatal.
What is congestive heart failure?
Congestive heart failure happens when the heart isn’t strong enough to pump all of your blood. Your heart is divided into two halves—the bottom half pumps blood out to the body, and the top half brings in returning blood. During heart failure, the bottom half is too weak to pump out all incoming blood.
When this happens, blood starts to “back up.” Fluid builds up around the heart, and can back up into the lungs, causing lung congestion. Meanwhile, tissue throughout the body is starved for oxygen. This can quickly become fatal.
What are the symptoms of heart failure?
Congestive heart failure doesn’t always have symptoms. It can happen without the patient knowing it—and can occur slowly, over the course of days, weeks or longer. But it often does have symptoms, which may include:
- Swelling in the lower body
- Weight gain
- Increased urination
- Irregular heartbeat
- Coughing, wheezing or shortness of breath
- Chest pain
- Rapid breathing
- Skin turning blue
If caught early, congestive heart failure can be treated with medicines, surgery or both. But if left too long it can cause death.
Patients taking Onglyza have died of congestive heart failure.
Why weren’t doctors and patients warned?
Since 2008 the FDA has required that all new Type 2 diabetes drugs be evaluated for risk of heart problems. However, this requirement was very new when Onglyza was brought to market. AstraZeneca performed relatively minimal studies that uncovered no heart risk.
The FDA approved the drug, but requested that AstraZeneca do more in-depth studies to verify its data. The new round of studies tracked many patients for two years or more, and took many years to complete. This lead to the publication in late 2013 of a study in the New England Journal of Medicine (NEJM) that showed a shocking new finding: Onglyza patients have a 27% higher risk of hospitalization for heart failure.
In response to the study, the FDA convened its advisory committee in early 2014 and began a process of re-evaluating Onglyza. But the government moves slowly and has to verify all data. By the time the FDA finally issued a warning it was April 2015—approximately six years since Onglyza first went on the market. Now, Onglyza/saxagliptin carries warnings about the risk of heart failure.
Is AstraZeneca liable for heart problems caused by Onglyza?
Yes. Drug manufacturers are responsible for any harm caused by their products, if patients were not warned of the risk beforehand. And AstraZeneca could have voluntarily warned patients as soon as the NEJM study was completed in 2013. Instead, it waited almost two more years for the FDA to force it to act. It’s impossible to know how many medical emergencies could have been prevented had AstraZeneca acted sooner.
Many diabetes patients are understandably wary of taking drugs. But they were told that Onglyza is a safe, manageable medication that they could count on to balance their blood sugar. Doctors acted in good faith prescribing Onglyza because the side effects appeared minor compared to other diabetes drugs. Doctors and patients alike chose the drug without being aware of its true risks.
If you, or someone close to you, have suffered as a result of taking Onglyza, you have legal rights. You may have a case for receiving a financial recovery. This recovery cannot reverse the harm or loss you suffered. But it can help pay for the medical bills, drugs, lost work time, and other costs you face. You should speak to a lawyer immediately.
John Foy & Associates can help you. We charge nothing unless we get you a financial recovery. Call 404-400-4000 and get your FREE consultation today.