Onglyza, Kombiglyze and the Risk for Heart Failure – What They Knew, When They Knew It
In 2016 it was reported that 1 out of 11 people will suffer from diabetes and more than 30 million people in the U.S. alone have diabetes. Onglyza XR and Kombiglyze XR (saxagliptin) are oral medications used to lower blood sugar in patients with Type 2 Diabetes and are classified as DPP-4 Inhibitors. Unfortunately, these medications have been linked to heart failure, extended hospitalization, surgery, congestive heart surgery, cardiac arrest, and even death.
What They Knew
Onglyza is manufactured by the Bristol-Myers Squibb Company and was approved for market by the FDA in 2009. Kombiglyze was approved in 2010 and is manufactured by Bristol-Myers Squibb Company and AstraZeneca. Saxagliptin is a new new class of diabetic drug called dipeptidyl peptidase – IV (DPP-IV) which targets the slow release and availability of certain incretin hormones. Previous diabetic medications work by controlling hyperglycemia through stimulation of insulin that is released from the pancreas. Saxagliptin works by slowing down the incretin hormone (GLP-1) allowing for more glucose control. This lowers blood sugar levels by helping the body increase insulin production after meals.
The problem is that the GLP-1’s time in your system is approximately two minutes without Saxagliptin exposure but survives for at least three hours during exposure to this drug. Saxagliptin manipulates the hormone’s effect by enabling the process to continue for a much longer period of time than what the human body may process safely. This extended period of time can lead to the potential for critical heart complications.
When They Knew It
In December 2008, the FDA acknowledged that Saxagliptin drugs posed cardiovascular risks and stated that these companies that are creating new anti-diabetic medications for the treatment of type 2 diabetes should perform more studies to prove that the medications are safe. Unfortunately, Bristol-Myers Squibb Company and AstraZeneca ignored this request from the FDA and sold Saxagliptin for nearly five years before completing an adequately designed study focusing on the risks of heart failure, congestive heart failure, cardiac failure, and death related to those heart conditions.
At no time during the development of its Saxagliptin drugs did the pharmaceutical companies perform adequate studies to determine if their drug – and its drastic alterations of the natural incretin hormone cycle – could cause harmful effects to the heart. Such studies are essential when developing, and then marketing, diabetic drugs to diabetic individuals who are already at an increased risk for cardiovascular complications.
What Can You Do?
If you took Onglyza XR and Kombiglyze XR after 2009, were on the drug for at least 10 days, and suffered from heart failure, extended hospitalization, surgery, congestive heart surgery, cardiac arrest or a loved one died while taking this medication, then you may be able to make a claim. The pharmaceutical companies didn’t properly test this new medication before putting it on the market and now countless innocent patients have suffered from cardiac complications. Contact us today to see if we are able to help you.