Diabetes affects more than 29 million Americans and another 86 million have blood sugar levels high enough to be considered “pre-diabetic.” Onglyza is a type 2 diabetes medication and one of the first drugs of its kind approved by the FDA under new safety standards regarding cardiovascular safety. Despite these standards, Onglyza has been linked to an increased risk of heart failure and patients harmed by the drug are filing lawsuits against its manufacturers.
People with type 2 diabetes who took the drug Onglyza and experienced side effects are now filing lawsuits against the drug’s manufacturers. Onglyza has been linked to an increased risk of heart failure in some patients, as well as other complications.
If you took Onglyza and experienced serious side effects, you may have a claim and may be entitled to financial compensation. There may be significant cash payouts in the form of settlements for those affected by the drug.
Onglyza lawsuits accuse the drug’s manufacturers, Bristol-Myers Squibb and AstraZeneca, of designing a defective product and failing to warn about its risks. Lawyers and attorneys are filing Onglyza lawsuits on behalf of patients in courts nationwide, accusing both companies of:
- Designing a defective product
- Failing to warn about Onglyza’s risks
- Strict liability for designing a defective product
- Breach of express and implied warranties
Onglyza lawsuits have not been consolidated in a multidistrict litigation (MDL) or class action lawsuit. The Onglyza litigation is still in its early phases. No cases have gone to trial and no settlements or verdicts have been reached.
What is Onglyza?
Onglyza is a prescription medication used to treat adults with type 2 diabetes along with diet and exercise. Diabetes affects more than 29 million Americans and another 86 million have blood sugar levels high enough to be considered “pre-diabetic.”
Onglyza was developed by pharmaceutical giant Bristol-Myers Squibb (BMS) and approved by the U.S. Food and Drug Administration in July 2009. It belongs to a class of drugs called dipeptidyl peptidase-4 inhibitors, or DPP-4 inhibitors.
In February 2014, drug company AstraZeneca announced it was buying BMS’ interest in a diabetes medication alliance between the two companies. This included the company’s stake in Onglyza.
Just 10 days after the acquisition was finalized, the FDA announced it was investigating a possible link between Onglyza and the increased risk for heart failure. The agency’s investigation came after results from a clinical trial conducted by BMS and AstraZeneca were published in the New England Journal of Medicine in October 2013.
Since then, the FDA has issued several warnings regarding Onglyza. People who took the drug say they developed heart failure and other complications and are now filing lawsuits against BMS and AstraZeneca for failing to adequately warn the public about Onglyza’s risks.
How Does Onglyza Work?
Onglyza was one of the first drugs of its kind to gain FDA approval for the treatment of type 2 diabetes.
People with type 2 diabetes have a high level of sugar (glucose) in the blood because their bodies do not make or properly use the hormone insulin. Onglyza works by blocking the dipeptidyl peptidase-4(DPP4) enzyme, which inactivates hormones in the body that cause insulin to be released. This allows insulin to be released and blood sugar levels to drop.
Onglyza Side Effects
Onglyza has been associated with a number of different side effects that range from mild to severe. These side effects were reported in clinical studies and by patients taking Onglyza.
Some of the side effects and adverse reactions associated with Onglyza include:
- Upper respiratory tract infection
- Urinary tract infection
- Abdominal pain
- Stomach flu
- Peripheral edema
- Severe joint pain
- Bullous Pemphigoid (a rare skin condition causing large, fluid-filled blisters)
- Heart failure
- Hypersensitivity reactions
Since Onglyza’s approval in 2009, the FDA has issued a number of safety warnings about the drug. These warnings included risks of serious side effects that can lead to additional medical care, hospitalization and even death.
In February 2014, the FDA announced it was reviewing clinical trial data that suggested Onglyza may increase a person’s risk for heart failure. The results came from a trial conducted by drugmakers Bristol-Myers Squibb and AstraZeneca and published in the New England Journal of Medicine in October 2013.
The study found Onglyza increased a person’s risk for heart failure. In many cases, the heart was not pumping blood throughout the body well.
In April 2016, the FDA announced its findings from the safety review. The agency said Onglyza may increase a person’s risk of heart failure, especially in patients with heart or kidney disease. The type 2 diabetes medication Nesina (alogliptin) was also found to potentially increase the risk of heart failure.
The FDA warned patients to watch for these signs and symptoms of heart failure:
- 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
Severe Joint Pain
In August 2015, the FDA warned that Onglyza and other type 2 diabetes medications may cause severe joint pain in some patients. The agency warned the pain could develop as soon as one day and up to two years after starting the medications. Symptoms usually went away after patients stopped taking the drug.
Other type 2 diabetes medications that might cause severe joint pain are Januvia (sitagliptin), Tradjenta (linagliptin) and Nesina (alogliptin), according to the FDA.
Industry funded study finds Onglyza can increase heart failure risks
A study conducted by drug manufacturers Bristol-Myers Squibb and AstraZeneca found Onglyza increased the risk for heart failure compared to a placebo. The study was published in October 2013 in the New England Journal of Medicine.
The FDA ordered the study be completed after it established new rules for manufacturers of glucose-lowering therapies in 2008. Under the new rules, manufacturers of certain diabetes medications would have to demonstrate a drug’s cardiovascular safety before gaining approval from the federal agency. Onglyza was one of the first glucose-lowering drugs approved under the new rule.
The study conducted by BMS and AstraZeneca found Onglyza was similar to placebo regarding the risk of nonfatal heart attacks and strokes, but found the risk for hospitalization due to heart failure was higher in patients taking Onglyza.
The study involved more than 16,000 men and women over the age of 55 and 60 who had a history of heart disease or were at risk of developing heart disease, as well as other risk factors. The results of the study were published just a few months before the FDA announced it was reviewing the safety of Onglyza in regard to heart health in February 2014.
Onglyza Dosage & Administration
Onglyza is an oral tablet that should be taken once a day with or without a meal. The recommended dose is 2.5 mg or 5 mg. Onglyza tablets should not be split or cut.
Insulin – Taking Onglyza with insulin can increase a person’s risk for low blood sugar (hypoglycemia). A lower dose of insulin should be used to minimize this risk.
Sulfonylureas – These antidiabetes drugs can increase a person’s risk for low blood sugar when taken with Onglyza.
Ketoconazole – This antifungal medication significantly increased the amount of Onglyza in a patient’s blood. A low dose of Onglyza should be used to minimize risks if used in combination with these types of antifungal medications.
Who should NOT take Onglyza?
People with a history of heart failure or kidney problems should tell their doctor before taking Onglyza. These patients are at a higher risk for heart failure while taking the drug, based on a study conducted by Onglyza’s manufacturer.
Pregnant women should also speak with their doctors about starting or stopping treatment with Onglyza. There is limited data to show whether or not Onglyza is safe to mothers and the developing fetus.
Alternatives to Onglyza
People with type 2 diabetes have a number of treatment options they can discuss with their doctors. This includes eating a healthy diet and getting plenty of exercise, as well as treatments with medications.
DPP-4 inhibitors like Onglyza are relatively new types of diabetes drugs, but more traditional medications have been on the market longer. All diabetes medications carry risks, so patients should speak with their doctors about what is right for them.
Medications used to treat type 2 diabetes include:
- Thiazolidinediones (Avandia, Actos)
- Biguanides (Metformin)
- Alpha-glucosidase inhibitors
- Dopamine agonist
- Glucagon-like peptides
Onglyza label. (February 2017). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022350s018lbl.pdf
FDA. Safety Communication. “Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication – Risk of Heart Failure.” (April 2016). Retrieved from https://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm494252.htm
FDA. Safety Communication. “FDA Drug Safety Communication: FDA warns that DPP-4 inhibitors for type 2 diabetes may cause severe joint pain.” (August 2015). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm459579.htm
FDA. Safety Communication. “FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR).” (February 2014). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm385287.htm
FDA. Approval Letter. (July 2009). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022350s000ltr.pdf
FDA. Supplemental Approval Letter. (April 2016). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022350Orig1s014,200678Orig1s013ltr.pdf
AstraZeneca. Press Release. “AstraZeneca completes the acquisition of Bristol-Myers Squibb share of global diabetes alliance.” (February 2013.) Retrieved from https://www.astrazeneca.com/media-centre/press-releases/2014/astrazeneca-aquisition-bristol-myers-squibb-global-diabetes-alliance-03022014.html#
Healthline. “A Complete List Of Diabetes Medications.” (June 16, 2016). Kristeen Cherney. Retrieved from http://www.healthline.com/health/diabetes/medications-list#overview1
Centers for Disease Control and Prevention. Data and Statistics. “Diabetes Latest.” (June 17, 2014). Retrieved from https://www.cdc.gov/features/diabetesfactsheet/
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