Millions of Americans are struggling with type 2 diabetes, many of whom use medications to keep their high blood sugar levels under control. But for patients taking Onglyza, controlling glucose levels may come at the cost of an increased risk of heart failure.
Studies Point to Onglyza Heart Failure Risks
Onglyza is often used by diabetes patients because it does not result in weight gain. Its active ingredient saxagliptin may control sugar levels, but recently came under fire for its increased risk of pancreatitis and certain forms of cancer with prolonged use. Kombiglyze XR is also a cause for concern, as it contains saxagliptin and metformin to control blood sugars over a longer period of time.
Both Onglyza and Kombiglyze have been implicated in instances of heart failure, including:
- Clinical trials. Concerns were first raised about the heart complications of saxagliptin in the 2013 clinical trial, Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus, also known as the SAVOR trial. The study coordinators revealed that 3.5 percent of the type 2 diabetes patients taking saxagliptin were hospitalized with heart failure, while less than 3 percent of patients taking a placebo suffered similar complications. The researchers concluded that Onglyza was safe to use in diabetes patients, unless they had been diagnosed with both advanced heart failure and kidney problems.
- Study results. After the SAVOR trial was published, other researchers examined the data to discover the nature of cardiovascular risks in patients who had taken saxagliptin. In 2014, a new analysis of this trial found that patients most at risk of hospitalization due to heart failure had been taking saxagliptin for less than a year, had suffered previous heart failure, demonstrated higher levels of brain natriuretic peptide (BNP), and were likely to have chronic renal disease.
- FDA ruling. Early in 2015, the FDA held a panel vote on the dangers of Onglyza. The agency's expert advisers acknowledged the increased risk of heart failure cited in the SAVOR study, as well as the significant increase in hospitalization in Onglyza patients. While the panel chose to defend the drug's cardiovascular safety, it also recommended that medication manufacturer AstraZeneca include a warning of potential heart failure risk on the drug label.
What Should I Do If I Suffered Onglyza Complications?
So far, the FDA has not recalled or banned drugs containing saxagliptin; however, this does not mean the medications can be considered safe. Both the prescribing doctors and drug maker have a duty to inform patients of potentially-deadly side effects—and can be held responsible for injury costs caused by their negligence.
If you have suffered heart failure while taking Onglyza, we can help. Our dangerous drugs attorneys will fight on your behalf to get you the maximum amount you deserve for your suffering, and you will pay us nothing unless we win your case! Call us today at 800-237-3334 to discuss the details of your injury at no cost to you.