Diabetes is one of the greatest public health concerns in America. According to the Centers for Disease Control (CDC), 37 million people (over 1 in 10) in the United States have the disease. Doctors wrote 214 million prescriptions for diabetes drugs in 2018, making it the sixth-largest class of medications prescribed in the U.S.
What does this mean to pharmaceutical companies? Staggering potential profits. The diabetes care drug market in North America reached over $29 billion in 2019—and is predicted to keep growing in the coming years. According to Reuters, over 50 new diabetes medications have hit the market in the past 20 years.
Onglyza (Saxagliptin) Safety Concerns
The FDA approved the drug Onglyza in 2009 to treat type 2 diabetes, which counts for 90%-95% of all diabetes cases. Onglyza belongs to a newer class of antidiabetic medications that help regulate insulin levels. Since it was launched, however, Onglyza has been linked to several serious and potentially fatal cardiac side effects.
After-market medical studies showed that Onglyza patients had an increased risk of hospitalization due to heart failure. In 2016, the FDA released a safety announcement to warn the public about the dangers of Onglyza and other medications containing saxagliptin. They also added new warnings to drug labels. But by then, saxagliptin had been on the market for years, exposing hundreds of thousands of patients to potentially fatal side effects.
Hundreds of lawsuits have been filed against manufacturer AstraZeneca for the medications Onglyza and Kombiglyze XR (both of which contain saxagliptin). Onglyza lawsuits claim that AstraZeneca ignored patient safety, launching the drug into the market before thoroughly studying the health risks on diabetes patients.
In 2008, the FDA had announced a recommendation for the entire class of newer medications for type 2 diabetes. The guidance asked manufacturers to show that the new antidiabetic drugs did not cause an unacceptable increase in cardiovascular risk.
The manufacturer released Onglyza without that evidence. AstraZeneca didn’t complete the clinical studies until several years later—after making substantial profits and potentially causing substantial injuries to the public.
Patients have claimed that saxagliptin resulted in the following cardiac issues:
- Heart failure
- Congestive heart failure
- Heart attack
- Cardiovascular injury
- Heart-related death
Additional Onglyza lawsuits alleged pancreatic injuries, including pancreatitis and pancreatic cancer. Continue reading