A woman has filed a saxagliptin side effects lawsuit after she says the drug caused her to suffer congestive heart failure.
Saxagliptin is the active ingredient in Onglyza and Kombiglyze XR, both drugs that are prescribed to help lower blood sugar levels in patients with type-2 diabetes. Bristol-Myers Squibb and AstraZeneca make both medications.
Plaintiff Violet M. says she took either Onglyza or Kombiglyze XR between April 2013 and May 2016. She alleges the development of congestive heart failure is among the saxagliptin side effects she’s suffered.
Allegations that Saxagliptin Side Effects Were Hidden
Violet claims she never would have taken the medications if she had known the saxagliptin side effects could include heart failure, congestive heart failure and potentially death from heart failure.
She alleges that Bristol-Myers Squibb and AstraZeneca worked together to provide misleading information regarding saxagliptin’s safety profile and actively concealed the risks of serious complications.
These allegations are based on the SAVOR study (Saxagliptin Assessment of Vascular Outcomes Recorded in Patient with Diabetes Mellitus – Thrombolysis in Myocardial Infarction 53) that allegedly found patients taking saxagliptin had a “statistically significant increased risk of being hospitalized due to heart failure.”
The SAVOR test was not conducted until after both Onglyza and Kombiglyze XR were on the market, even though the FDA allegedly recommended the study back in 2008. The FDA reviewed the SAVOR data and voted 14 to 1 that a heart failure warning should be added to saxagliptin product labeling. One FDA committee member voted to remove saxagliptin from the market completely.
The saxagliptin side effects lawsuit alleges that even after direction from the FDA, the drug companies failed to acknowledge or inform the public or doctors about the heart failure risks. Ongylza and Kombliglyze XR purportedly were continued to be promoted as safe and effective medications to control blood sugar in type-2 diabetes patients.
Signs of Saxagliptin Side Effects
Saxagliptin belongs a class of drugs known as incretin mimetics, which act by stimulating the pancreas to make insulin. Avandia was an incretin mimetic, and it was taken off the market after being linked to an increased risk of heart-related death.
When the heart pumps blood at a slowed pace, the heart muscle becomes weak. Over time, the body’s organs suffer from not receiving an adequate supply of oxygen and nutrients that the blood usually delivers. Combined with fluid retention, the patient can eventually suffer congestive heart failure.
Indications that saxagliptin side effects are causing heart failure include:
- Marked shortness of breath during daily activities
- Breathing problems upon lying down
- Tiredness, weakness, or extreme fatigue
- Gaining weight and swelling of the ankles, feet, legs or stomach
- Rapid or irregular heartbeat
- Nagging cough or wheezing with white or pink blood-colored phlegm
- Increased need to urinate in the night
- Lack of appetite, nausea
- Reduced ability to exercise
If you have suffered saxagliptin side effects after taking either Onglyza or Kombiglyze XR, you could be eligible for compensation through legal representation.
The Saxagliptin Side Effects Lawsuit is Case No. 5:18-cv-00370-KKC in the U.S. District Court for the Northern District of West Virginia (Martinsburg Division).
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