In a new lawsuit, a man is claiming that drug company Bristol-Myers Squibb failed to provide a proper Onglyza heart failure warning to patients.
Plaintiff Robert C. claims that AstraZeneca along with Bristol-Myers Squibb hid the possibility of heart failure for patients who take Onglyza, and that information that was presented to patients about the safety of the drug was misleading and false.
Robert claims that the drug companies should have provided a better Onglyza heart failure warning to him and other patients. He says that he developed heart failure after he began taking both Onglyza and Kombiglyze XR. Kombiglyze combines metformin with saxagliptin, the active ingredient in Onglyza.
He also says that AstraZeneca and Bristol-Myers Squibb were aware of the possible heart complications yet failed to provide an Onglyza heart failure warning.
Onglyza, generically known as saxagliptin, was approved by the U.S. Food and Drug Administration in 2009 for the treatment of diabetes. If paired with a good diet and exercise, Onglyza can control high blood sugar in those who suffer from type-2 diabetes.
People often opt to take Onglyza because it is effective and it also does not encourage weight gain like many other type-2 diabetes drugs. In 2015 alone, sales for Onglyza reached nearly $800 million.
Onglyza works by inhibiting an enzyme whose job it is to break down a hormone that signals insulin to be produced. If this enzyme is inhibited, the hormone is not broken down, thus allowing the body to produce more insulin.
However, there have been studies that show that Onglyza may be the reason behind an increase in heart failure among patients. In 2013, when looking at both the SAVOR test and the EXAMINE test, the FDA found that there was a 27 percent increased risk for hospitalization due to heart failure in patients who took Onglyza.
The EXAMINE study looked at over 5,000 patients. Almost 4% were hospitalized for heart failure as opposed to 3.3 percent for those patients taking a placebo.
Heart failure is the inability of the heart to pump blood throughout the body to where it needs to go. Those who suffer from heart failure may experience congested lungs, bloating, increased need to urinate, dizziness, fatigue and rapid or irregular heartbeats.
Many researchers wonder if the benefits of Onglyza aren’t enough to actually warrant the increase in the risk of heart failure.
It wasn’t until 2016 that the drug makers issued an Onglyza heart failure warning for their drug. The FDA, in April 2016, issued an Onglyza heart failure warning safety communication that stated, “type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.”
Many others, besides Robert, have filed lawsuits claiming that AstraZeneca and Bristol-Myers Squibb did not do enough to provide a proper Onglyza heart failure warning to patients.
If you or someone you love has experienced heart failure while taking Onglyza, you may benefit from speaking with an experienced attorney.
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