When Onglyza was first released, it offered hope to nearly 30 millions Americans who suffer from Type 2 diabetes. But, according to the U.S. Food and Drug Administration, the medication puts patients at a greater risk of being hospitalized for heart failure.
Now, Onglyza patients are filing lawsuits against AstraZeneca and Bristol-Myers Squibb over claims that the pharmaceutical companies failed to warn patients and healthcare providers about the risks.
What is Onglyza?
Onglyza, also known by its generic name saxagliptin, was first approved for use in the United States to treat Type 2 diabetes in adults by the FDA in July 2009. The medication is designed to be used in conjunction with diet and exercise to get high blood sugar levels under control.
Type 2 diabetes is a chronic condition in which the body does not metabolize sugar properly. When Type 2 diabetes is diagnosed, it can be treated with lifestyle changes, medications, and additional insulin. According to the Centers for Disease Control and Prevention, 29.1 million people in the United States have diabetes with another 8.1 million potentially undiagnosed and unaware of the condition.
Symptoms of Type 2 diabetes include:
- Excessive thirst
- Frequent urination
- Blurred vision
- Increased hunger
- Slow-healing sores
- Frequent infections
- Patches of dark skin
Officials at AstraZeneca hailed Onglyza at the time of the initial approval as “an important new treatment to help improve glycemic control.”
Onglyza quickly became a big seller for AstraZeneca and Bristol-Myers Squibb. Some analysts say sales could peak at $1.8 billion a year in 2018.
How Does Onglyza Work?
Onglyza is in a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. The medication helps lower blood sugar in the body by increasing the level of insulin the pancreas makes after a meal.
It works by increasing the amount of two hormones in the body: glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). Both hormones are typically made to control blood sugar levels during meals. However, in those with diabetes, an enzyme known as dipeptidyl peptidase-4 (DPP-4) breaks down the two hormones.
Onglyza prevents DPP-4 from breaking down the hormones.
All DPP-4 Inhibitors (With Active Ingredients)
- Onglyza (Saxagliptin)
- OJanuvia (Sitagliptin)
- OGalvus (Vildagliptin)
- OTradjenta (Linagliptin)
The recommended dose of Onglyza is a 2.5 mg or 5 mg pill taken once a day. Dosage depends on patients with renal impairments or renal diseases.
Onglyza Side Effects
According to the prescribing information sheet, some of the most common Onglyza side effects include:
- Upper respiratory tract infection
- Urinary tract infection
Serious Onglyza Side Effects
Serious side effects of Onglyza include but are not limited to:
- Pancreatitis (inflammation of the pancreas)
- Heart failure
- Low blood sugar levels
- Swelling or fluid retention
- Joint Pain
- Allergic reactions
FDA: Onglyza Increases Risk of Heart Failure
In December 2008, the FDA implemented a new guidance asking manufacturers that make Type 2 diabetes drugs to prove the drugs do not increase the risk of cardiovascular events.
Although AstraZeneca and Bristol-Myers Squibb ignored the guidance while it marketed the drug in 2009, Onglyza was one of the first diabetes drugs to complete a safety study.
The study, which was presented in 2013, involved more than 16,000 patients taking Onglyza. It proved that Onglyza did not increase cardiovascular disease by 30 percent or more, which was the threshold under the FDA guidance.
Despite being under the 30 percent threshold, the study revealed a 27 percent increase in the rate of hospitalization for heart failure and a possible increased risk for all-cause mortality, according to the FDA.
Based on the data, 14 of 15 panelists from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to update the label for Onglyza in 2015 to reflect an increased risk for heart failure. One panelist voted to remove Onglyza from the US market entirely.
The panel acknowledged a potential increased risk of overall death but needed to establish a stronger connection before adding it to the label.
“An effect on all-cause mortality really cannot be ruled out,” panelist Robert J Smith, committee chair and professor of medicine at Alpert Medical School of Brown University, said at the time.
Onglyza Labels Updated with Heart Failure Warning
About a year after the panel voted for an update to Onglyza’s label, the FDA released a safety announcement warning that drugs containing saxagliptin may increase the risk of heart failure.
“In the saxagliptin trial, 3.5% of patients who received the drug were hospitalized for heart failure versus 2.8% of patients who received a placebo,” the FDA said in its April 2016 announcement.
Starting that same month, the label for Onglyza was changed to include a warning of an increased risk of pancreatitis and heart failure.
Hundreds of Patients File Onglyza Lawsuits
Following the updates from the FDA, patients who took Onglyza began filing lawsuits against AstraZeneca and Bristol-Myers Squibb over claims that they faced elevated risks of heart failure from the drug.
Suits were originally filed in California in September 2016 before being refiled in New Jersey in February 2017. The 14 suits filed in New Jersey allege that Onglyza was sold in 2009 without conducting the clinical trials suggested in the FDA’s 2008 guidance.
Plaintiffs also said that the makers of Onglyza knew about the risks but failed to notify patients or healthcare professionals.
“The suits allege a design defect and seek to recover on grounds of negligence, failure to warn, breach of warranty of merchantability, and breach of express warranty and implied warranty,” according to the New Jersey Law Journal. “The plaintiffs seek to recover for pain and suffering, economic damages, emotional distress, lost wages and medical expenses.”
Hundreds of cases alleging a failure to warn and negligence are currently pending across the United States with some estimating the number to rise into the thousands, according to an attorney who spoke to FiercePharma.
The Importance of Onglyza Lawsuits
Between 2009 and 2016, Onglyza was sold to the public without any warnings of the increased risk of heart failure. Thousands of patients who took the drug to treat Type 2 diabetes were put at risk without any knowledge.
Drug manufacturers have the duty to inform the public about the side effects associated with its products. When they fail to do that, they need to be held accountable.
Filing a lawsuit helps bring the negligence to light and encourages more ethical business practices. Not only does a lawsuit help ensure it doesn’t happen again but victims can also get compensation for the company’s negligence.
Together we can hold pharmaceutical companies accountable and get you the justice you deserve.