Our firm is investigating product liability lawsuits on behalf of individuals who developed heart failure after taking the diabetes drug Onglyza (saxagliptin), manufactured by AstraZeneca and Bristol-Myers Squibb (BMS). Drug injury lawsuits have been filed over Onglyza heart failure risks, alleging that the pharmaceutical companies failed to include information about heart failure on the drug label.
The U.S. Food and Drug Administration (FDA) updated the label on drugs containing saxagliptin and alogliptin in April 2016 to warn about the potential increased risk of heart failure. Saxagliptin is an active ingredient in Onglyza and Kombiglyze XR (saxagliptin and metformin extended release).
If you or someone you know took Onglyza or Kombiglyze XR and suffered cardiac arrest, congestive heart failure, or death contact one of our experienced drug injury attorneys today. Parker Waichman LLP offers free, no-obligation legal consultations.
AstraZeneca, BMS Sued over Onglyza Heart Risks
AstraZeneca and BMS are facing product liability lawsuits alleging that its saxagliptin products Onglyza and Kombiglyze XR caused heart failure. According to a Fierce Pharma article published May 8, 2017, some 14 lawsuits were filed in the District of New Jersey alleging that the drug makers failed to warn about heart failure risks.
Plaintiffs suing over Onglyza and Kombiglyze allege that the label failed to disclose an increased risk of cardiac arrest, congestive heart failure, and death.
According to the New Jersey Law Journal, Onglyza heart failure lawsuits were initially filed September 2016 in San Francisco. On February 1, 2017; however, a San Francisco judge granted a motion to defendants to sever and dismiss non-Californian plaintiffs. Subsequently, the lawsuits were re-filed in New Jersey.
Plaintiffs allege that AstraZeneca and BMS failed to conduct clinical testing to determine whether Onglyza increased heart failure risks before gaining approval for the diabetes drug in 2009. Lawsuits note that the FDA called on makers of diabetes drugs in 2008 to show that their products do not present cardiac risks.
Onglyza and Kombiglyze lawsuits allege that the companies were aware of heart failure risks, but failed to warn patients or their physicians. Plaintiffs allege that they would not have taken saxagliptin if they were fully informed of the risks.
The lawsuits allege that the drugs contain a design defect. AstraZeneca and BMS are being sued for negligence, failure to warn, breach of warranty of merchantability, and breach of express and implied warranty. Plaintiffs are seeking damages for medical expenses, lost wages, economic damages, pain and suffering, and emotional distress.
The lawsuits also assert that any applicable statute of limitations should be tolled due to the companies’ alleged fraudulent concealment under specific circumstances.
Plaintiffs in the litigation suffered congestive heart failure or other problems. Some lawsuits are wrongful death claims filed on behalf of people who died after taking the diabetes medication.
FDA Updates Label on Onglyza, other Diabetes Meds to Warn of Heart Failure
In April 2016, the FDA announced that the labels on medications containing saxagliptin or alogliptin would be updated to include the risk of heart failure. Patients with existing heart or kidney disease are especially at risk, regulators said.
According to the Safety Announcement, the label update affected the following medications:
- Onglyza (saxagliptin)
- Kombiglyze XR (saxagliptin and metformin extended release)
- Nesina (alogliptin)
- Kazano (alogliptin and metformin)
- Oseni (alogliptin and pioglitazone)
These Type 2 diabetes drugs are classified as dipeptidyl peptidase-4 (DPP-4) inhibitors. They are used to lower blood sugar in patients diagnosed with Type 2 diabetes, in combination with diet and exercise.
Diabetes is a condition in which the body is unable to metabolize sugar (glucose) properly, leading to increased blood sugar levels. In patients with Type 1 diabetes, the body does not produce enough insulin, the hormone that directs cells to take up glucose. In patients diagnosed with Type 2 diabetes, the body develops a resistance to insulin, and stops responding to the hormone normally.
When a patient suffers from heart failure, it means that the heart cannot pump blood well enough to sustain the rest of the body. The FDA notes that patients taking DPP-4 inhibitor drugs should seek medical attention immediately if they experience symptoms of heart failure, including:
- Unusual shortness of breath during daily activities
- Trouble breathing when lying down
- Tiredness, weakness, or fatigue
- Weight gain with swelling in the ankles, feet, legs, or stomach
Regulators indicated that patients should not stop taking their diabetes medications without consulting with their doctor first.
The FDA also indicated that its “safety review has found that 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. Heart failure can result in the heart not being able to pump enough blood to meet the body’s needs. As a result, we are adding new warnings to the drug labels about this safety issue.”
Previously, the agency announced that it would review heart failure risks associated with Onglyza and Kombiglyze in February 2014. At the time, the FDA indicated that it asked drug makers to submit clinical data on the issue. The review was prompted by a study published in the New England Journal of Medicine (NEJM), which found a higher rate of heart failure hospitalization associated with saxagliptin compared to an inactive ingredient (placebo).
The NEJM study, published in October 2013, evaluated cardiovascular events in 16,492 patients taking either saxagliptin or a placebo. Researchers followed participants for about two years. Overall, authors found that saxagliptin use was associated with a higher rate of hospitalization for heart failure; however, the drug did not significantly affect the rate of ischemic events.
Clinical Trial Data Suggests Onglyza Increases Heart Failure Risk
The FDA updated the warning label on Onglyza, Kombiglyze and other similar drugs after the FDA Endocrinologic and Metabolic Drugs Advisory Committee convened a meeting in April 2015. The expert panel discussed data from two large clinical trials evaluating patients with heart disease; the FDA also evaluated these studies.
In each trial, saxagliptin- or alogliptin-containing medications were associated with a greater risk of being hospitalized for heart failure compared to patients taking a placebo. In the saxagliptin trial, 3.5 percent of patients taking saxagliptin were hospitalized for heart failure. Comparatively, 2.8 percent of patients taking a placebo were hospitalized for heart failure. These figures equate to 35 out of every 1,000 patients versus 28 out of every 1,000 patients, respectively. The risk was higher among patients with a history of heart failure or kidney problems.
The risk of heart failure was also higher among patients taking alogliptin compared to those taking a placebo, clinical data from the alogliptin trial showed. Among patients taking alogliptin, 3.9 percent were hospitalized for heart failure compared to 3.3 percent of those taking a placebo. These figures equate to 39 out of every 1,000 patients and 33 out of every 1,000 patients, respectively.
Upon reviewing data from the SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) trial, which contained data from 16,000 patients, the FDA panel noted in 2015 that the Onglyza warning label should be updated to include the risk of heart failure. Panelists noted a 27 percent increased risk of heart failure hospitalizations in patients taking saxagliptin compared to placebo.
Filing an Onglyza Heart Failure
If you or someone you know has questions about filing an Onglyza heart failure lawsuit, contact Parker Waichman today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
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