Onglyza – Heart Failure

Onglyza lawsuit imageIn April of 2015, an FDA safety panel recommended that additional warnings be added to prescribing information for the popular antidiabetic medication, Onglyza, due to concerns about an increased risk of heart failure.

A medical study involving over 16,000 patients showed that Onglyza increased the occurrence of heart failure-related hospitalization by as much as 27 percent and the FDA safety panel concluded that an increased risk of death from all causes could not be ruled out.

Onglyza has been suspect previously due to the action of similar drugs which may increase the risk of pancreatitis and pancreatic cancer but no direct link to Onglyza has been found yet.  One safety panel member voted to withdraw the drug from the market but the overall recommendation was for increased labelling which may ultimately be added to Onglyza and similar medications.

About Onglyza

Onglyza (saxagliptin) is an antidiabetic medication of a “new” type, the “Dipeptidyl peptidase-4 inhibitors” (DPP-4) or “gliptins”.  It was first approved in 2009 for the treatment of Type 2 diabetes.  It is to be used “in combination” with diet and exercise to lower blood sugar in non-insulin dependent diabetics.

Onglyza is manufactured and marketed by the London-based, AstraZeneca, a pharmaceutical giant with an estimated annual income of $26 billion.  The medication brought in approximately $820 million in 2014 alone.

About DPP-4 Inhibitors

Type 2 diabetes affects millions of American adults and is responsible for 95 percent of all diabetes cases.  It is caused by the body’s inability to produce enough insulin or a decreased sensitivity of the body cells to existing insulin which is needed to transport gludose from the blood stream into the cells where it can be used as energy.  If glucose remains in the bloodstream, it becomes “toxic” to many body tissues, particularly the kidneys, eyes, and vascular tissue.

DPP-4 inhibitors work to lower blood sugar by blocking glucose release from the liver, by increasing the secretion of insulin from the pancreas and by decreasing “gastric emptying time” in the stomach which results in a lower absorption of sugar.

These actions are accomplished by increasing the activity of a naturally-occurring hormone, incretin.  Certain other antidiabetic medications work similarly by acting as synthetic incretins or incretin “mimetics”.

Incretin type drugs that act similarly to the DPP-4 inhibitors like Onglyza, have been suspected of causing a number of serious side effects and have been the subject of numerous lawsuits.

Onglyza Heart Failure

In 2008, after many “new” type antidiabetic drugs had begun showing signs of high rates of serious adverse events, the Food and Drug Administration began requiring manufacturers perform safety studies to show that any additional drugs intended for market did not pose a higher than normal heart risk.  The FDA’s requirements indicated that drugs could show no more than a 30 percent increase in heart events.

Onglyza was one of the first of the newer generation Type II antidiabetic medications to comply with the request for additional testing.  The results of the study designed to answer that question were published in a 2013 New England Journal of Medicine article.  The results showed a 27 percent increase in heart failure-related hospitalizations.

Though the 2013 SAVOR study results were technically below the 30 percent threshold, the FDA’s review of the trial prompted an investigation which has concluded that there may also be an increased risk of overall death.  One safety review panel member indicated a belief that the drug should be withdrawn but the panel of the FDA voted in April of 2015 to recommend additional warning be added to prescribing information for Onglyza and one other DPP-4 inhibitor.

Thus far, the FDA has not taken official action and may be waiting on study results from other DPP-4 inhibitors before making a final judgement.

Symptoms of heart failure can include:

  • Continuing cough
  • Wheezing
  • Difficulty breathing
  • Swelling of hands, feet or ankles
  • Irregular heart rate
  • Fatigue or activity intolerance

Onglyza Cancer

Some incretin-type medications have shown the possibility for a higher than normal risk of pancreatitis, which may increase the risk of pancreatic cancer.  March 2013 study results published in Diabetes magazine showed that certain incretin or incretin mimicking drugs may increase pancreatic mass and induce precancerous changes.

Though the study was not conducted on Onglyza, the activity of DPP-4 inhibitor’s similarity has raised concerns about the medication’s potential for increased cancer risk.

Pancreatitis may cause symptoms such as:

  • Pain in upper stomach, possibly radiating to back
  • Nausea and vomiting
  • Abdominal tenderness
  • Fever
  • Rapid heart rate

Other Onglyza Side Effects

In addition to the potential for increased heart failure and cancer risk, Onglyza may also cause other side effects such as:

  • Nasal stuffiness or runny nose
  • Sore throat
  • Headache
  • Nausea
  • Diarrhea
  • Painful urination
  • Bloating

Onglyza may also cause allergic reactions such as:

  • Rash
  • Hives
  • Itching
  • Swelling of face, tongue or lips
  • Difficulty breathing

Any symptoms of heart failure, pancreatitis, or serious allergic reaction should warrant immediate medical attention.

Onglyza Lawsuit

The antidiabetic group of medications, particularly “new” medications like Onglyza, has proven to be troublesome.  Even though they have been designed to be helpful and improve the lives of diabetics, many new medications have caused serious injury and resulted in thousands of lawsuits.

Injury caused by antidiabetic medication can be costly, resulting in years of additional medical expenses, loss of wages and pain and suffering.  Patients or family members of those injured by antidiabetic medications may be eligible for compensation for those losses.  Families of those who have died due to medication injury may be eligible for wrongful death compensation but each occurrence of medical injury is unique and must be considered on its own merits.

If you or a family member has been injured after using Onglyza, you may be eligible for compensation but a lawsuit is no guarantee of a settlement and each case should be evaluated independently by legal experts. Learn more about Onglyza lawsuits here.



View Sources
  1. AstraZeneca, (2015), Onglyza Prescribing Information, AstraZeneca, Accessed on 27 July 2015
  2. AstraZeneca, (2015), Onglyza Medication Guide, AstraZeneca, Accessed on 27 July 2015
  3. AstraZeneca, (14 April 2015), FDA Advisory Committee reviews SAVOR outcomes study results for ONGLYZA® (saxagliptin) and KOMBIGLYZE® XR (saxagliptin and metformin HCI extended-release), AstraZeneca, Accessed on 27 July 2015 http://www.astrazeneca.com/Media/Press-releases/Article/20150414-fda-committee-reviews-savor
  4. Ault, A., (14 April 2015) FDA Panel Backs New Safety Warnings on Two Diabetes Drugs, Medscape, Accessed on 27 July 2015 http://www.medscape.com/viewarticle/843179#vp_2
  5. Barber, J., (10 April 2015), FDA staff suggest AstraZeneca's diabetes drug Onglyza linked to higher rate of death, FirstWord Pharma, Accessed on 27 July 2015 http://www.firstwordpharma.com/node/1274816#axzz3h6ueRxBy
  6. Butler, A. E., et al., (2013), Marked expansion of exocrine and endocrine pancreas with incretin therapy in humans with increased exocrine pancreas dysplasia and the potential for glucagon-producing neuroendocrine tumors, Diabetes, Accessed on 27 July 2015 http://diabetes.diabetesjournals.org/content/early/2013/03/17/db12-1686.abstract?sid=c292a1eb-fefa-4077-927d-651738e22e43
  7. DIC, (17 April 2015), FDA Panel Recommends New CV Safety Warnings on Onglyza and Nesina DPP-4s, Diabetes In Control, Accessed on 27 July 2015 http://www.diabetesincontrol.com/articles/diabetes-news/17836-fda-panel-recommends-new-cv-safety-warnings-on-onglyza-and-nesina-dpp-4s-
  8. Edney, A., (10 April 2015), AstraZeneca’s Diabetes Drug May Raise Death Risk, FDA Says, Washington Post, Accessed on 27 July 2015 http://washpost.bloomberg.com/Story?docId=1376-NMJYUA6K50Y801-53MNTEOCO89HLNRGD1KQLFPBSK
  9. European Medicines Agency, (26 August 2013), Investigation into GL-1-based diabetes therapies concluded, EMEA, Accessed on 27 July 2015 http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/07/news_detail_001856.jsp&mid=WC0b01ac058004d5c1
  10. Food and Drug Administration (11 February 2014), FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR), U.S. Food and Drug Administration, Accessed on 27 July 2015 http://www.fda.gov/Drugs/DrugSafety/ucm385287.htm
  11. Hirschler, B., (02 September 2013), Doctors get good and bad safety news on diabetes drugs, Reuters, Accessed on 27 July 2015 http://www.reuters.com/article/2013/09/02/us-heart-diabetes-idUSBRE98103I20130902
  12. McDougall, C., et al., (2011), Drugs for Diabetes: Part 5 DPP-4 inhibitors, British Journal of Cardiology, Accessed on 27 July 2015 http://www.medscape.com/
  13. Perry, S, (10 June 2013), New generation of diabetes drugs raising more concerns, Minnesota Post, Accessed on 27 July 2015 http://www.minnpost.com/second-opinion/2013/06/new-generation-diabetes-drugs-raising-more-concerns
  14. Scirica, B., et al., (03 October 2013), Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus, New England Journal of Medicine, Accessed on 27 July 2015 http://www.nejm.org/doi/full/10.1056/NEJMoa1307684