Onglyza Manufacturer Likely Knew Heart Failure Risk Before Approval
Almost 10% of the U.S. population has Type 2 diabetes. This means big bucks for pharmaceutical companies like AstraZeneca. They knew if they could develop a medication to treat Type 2 diabetes, then they could cash in. Expected annual sales of these drugs will reach $2.47 billion by 2018.
Plaintiffs allege that AstraZeneca knew their Type 2 diabetes medication, Onglyza could cause heart failure and never notified the American consumer. The company put profits over patient safety.
After a 52-week study conducted by AstraZeneca, they found Onglyza and Kombiglyze XR (both saxagliptin medications) help break down the hormones needed to control blood sugar levels. Both drugs are a member of a class of drugs called DPP-4 inhibitors. DPP-4 is an enzyme that raises those hormones, and thus, leads to an increase in insulin.
When AztraZeneca submitted this study to the FDA for approval, the main side effect they noted was an upper respiratory infection. There wasn’t any mention of heart failure.
Onglyza & Heart Failure
Ongoing litigation alleges that AstraZeneca likely knew Onglyza had the potential for heart failure as early as 2006. This is three years before the FDA approved the drug. Heart failure is a potentially deadly condition. It arises when the heart does not pump blood thoroughly enough to satisfy the needs of the body. According to the Centers for Disease Control and Prevention, heart failure contributed to 1 in every 9 deaths in the U.S. in 2009. Half of all people who develop heart failure will die within 5 years of the diagnosis, according to the CDC.
The FDA didn’t even know that Onglyza was killing people until 2014. This is 5 years after approval. This is when the FDA demanded an investigation into the link between saxagliptin use and heart failure. The new study revealed that 35 out of every 1,000 patients using saxagliptin-containing drugs were hospitalized. This is a 35% increased risk of heart failure. Ten percent more than those who received the placebo.
Two years later, the FDA finally mandated a label change for all drugs containing saxagliptin to warn of heart failure risk. Unfortunately, this labeling did not come soon enough for many. A study published nearly four years ago showed that almost 20% of participants had an adverse reaction to saxagliptin and nearly 5% died. Many people could have been saved.
Choosing the Right Attorney
Saxagliptin medications like Onglyza and Kombligyze XR have hurt thousands of people. It is important that if Onglyza hurt you to contact a law firm, who has experience and the resources to get you the compensation you deserve. The Michael Brady Lynch Firm is that firm. We have decades of experience at recovering millions for clients. This is why we have received a high degree of peer recognition and professional achievement, such as inclusion on numerous Plaintiff Steering Committees. We will take whatever legal measures are necessary when fighting for your rights to damages.