The U.S. Food and Drug Administration (FDA) is advising the public that it is evaluating a study showing that the type 2 diabetes drug saxagliptin hydrochloride—sold under the brand names Onglyza and Kombiglyze XR—might cause heart failure side effects and an increased risk of pancreatitis.
What Is Onglyza and What Is It Prescribed For?
Onglyza is the brand name for the drug saxagliptin. First made and sold by the American pharmaceutical company Bristol-Myers Squibb, this prescription medication is used to treat type 2 diabetes. The FDA approved the drug in 2009, and it is sold in tablet form. Bristol-Myers Squibb also makes Kombiglyze XR, approved in 2010, which combines saxagliptin with the mainstay diabetes drug metformin hydrochloride. In February 2014, the British Pharmaceutical company AstraZeneca plc announced it would buy Bristol-Myers Squibb’s $4.1 billion stake in a joint enterprise to create diabetes drugs. The deal includes transferring the rights for Onglyza to AstraZeneca.
Onglyza is a dipeptidyl peptidase-4 (DPP-4) inhibitor drug. DPP-4 is an enzyme that breaks down two types of intestinal hormones called incretins, GLP-1 and GIP. The human body releases these hormones during meals. Onglyza reduces the levels of the two incretins, leading to increased insulin and decreased blood sugar levels and easing the symptoms of type 2 diabetes.
Like similar DPP-4 inhibitor drugs, Onglyza has been controversial since its 2009 introduction. In February 2011, the consumer group Public Citizen in its “Worst Pills, Best Pills” publication discouraged people from using Onglyza due to incomplete knowledge of its risks and benefits. It told people to wait until 2016 when research results were due to be published before using Onglyza to treat diabetes.
Onglyza Might Cause Heart Failure Side Effects and Increased Risk of Pancreatitis
Onglyza Pancreatitis Risk Side Effects
On March 14, 2013, the FDA issued a drug safety communication informing the public that it is evaluating unpublished findings by researchers that connected Onglyza and other diabetes drugs with pancreatitis and cellular changes called “pancreatic duct metaplasia.” The agency is requesting the researchers provide it with their research methodology and tissue samples they used.
Onglyza Heart Failure Side Effects
On February 11, 2014, the FDA issued another drug safety communication, this one specifically aimed at Onglyza. A study published in the New England Journal of Medicine found an increased rate of hospitalization for saxagliptin users due to heart failure compared to nonusers of the drug. The study did not find a connection between death, heart attack, and stroke. Although the agency considered the findings “preliminary,” it asked Bristol-Myers Squibb to submit the clinical data for review.
Already, some Onglyza lawsuits have been filed, and some may join the incretin mimetic multidistrict litigation (MDL) ongoing in the U.S. District Court for the Southern District of California.
RLG’s Onglyza Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an Onglyza lawsuit on your behalf if necessary. RLG will also keep you up to date on any Onglyza class action lawsuits, additional FDA Onglyza warnings, and Onglyza FDA recall announcements. If you or a loved one has taken Onglyza, and you believe it caused an injury, contact RLG today.