The U.S. Food and Drug Administration (FDA) recently asked the manufacturers of Onglyza, a drug to treat Type 2 diabetes, to update the drug’s warning label to more accurately reflect the increased risk of several dangers associated with its use, including heart failure.
Onglyza (saxagliptin) is classified as an incretin mimetic, which acts to stimulate the release of insulin to help regulate a patient’s blood sugar level. It was introduced in 2009 by AstraZeneca and Bristol-Myers Squibb.
Onglyza is attractive to some patients because it doesn’t cause weight gain, a common side effect in other type 2 diabetes drugs. However, one serious Onglyza side effect is an increased risk of heart failure, a serious and potentially life-threatening condition where the heart becomes too weak to pump blood throughout the body.
In February 2014, the FDA requested clinical trial data from Onglyza manufacturers to investigate the possible association between the type 2 diabetes drug and heart failure. That request followed a study published in the New England Journal of Medicine, which reported an increased hospitalization rate for heart failure among Onglyza users.
The FDA also said that it has received reports of other serious Onglyza side effects, including an increased risk for acute pancreatitis, pancreatic cancer and thyroid cancer. Both pancreatic and thyroid cancers are difficult to detect until the later stages of the disease, which makes these side effects even more dangerous for Onglyza patients.
A number of lawsuits have been filed against AstraZeneca and Bristol-Myers Squibb, alleging that the manufacturers failed to adequately inform and warn medical professionals and consumers about the serious risks associated with Onglyza.
If you have suffered injuries from an unsafe or defective medical product, the experienced product liability legal team at Roberts & Roberts is here to help with compassionate, aggressive representation. Please call 800-248-6000 or contact us for a free consultation.