FDA Warns of Heart Risks in Onglyza, Nesina Diabetes Drugs

Thursday, April 7, 2016

Two popular type-2 diabetes drugs are in the news after the FDA warned this week that patients taking them may face higher risks of heart failure.

The new warning, issued Tuesday, focuses on the DPP-4 inhibitors Onglyza (saxagliptin), sold by AstraZeneca, and Nesina (alogliptin), sold by Takeda. Together, these drugs are prescribed more than 3 million times each year.

Onglyza and Nesina work by increasing certain hormones that inhibit glucagon to reduce blood sugar levels and raise insulin levels. They are only designed to treat type-2 diabetes.


Heart Failure Risks Uncovered in 2013

The recent warnings come after the heart failure warnings were first uncovered in studies published in the New England Journal of Medicine in October of 2013.

The SAVOR study was conducted by doctors at Harvard Medical School and Brigham and Women’s Hospital, following nearly 16,500 patients taking either Onglyza or a placebo. Researchers found that those taking Onglyza were 27% more likely to be hospitalized for heart failure.

In another study of more than 5,000 patients, titled EXAMINE, researchers at the University of Connecticut discovered that those taking Nesina were 19% more likely to be hospitalized for heart failure than people taking a placebo.


FDA Panel Addresses Rise in Heart Failure Complications

In February of 2014, in a reaction to the SAVOR study results, the FDA announced it would begin an investigation into the increased risks of heart failure or death among patients taking Onglyza.

So far, according to agency records, the FDA has received reports of 113 patients taking Onglyza suffering heart failure, a heart attack or heart disease. They have also received 46 reports of patient death.

Among Nesina users, adverse event reports to the FDA show 30 patients suffering heart conditions and 19 suffering death.

In April of 2015, the FDA assembled a panel of experts to recommend a course of action with regards to DPP-4 diabetes drugs like Onglyza, due to the heightened heart risks. The panel voted 14-1 in favor of recommending new label warnings for Onglyza to alert of heart failure.


April 2016 FDA Warning for Onglyza, Nesina

In its latest move, the FDA issued a safety advisory this month for both Onglyza and Nesina, and will require that new warnings be added to the labels of both drugs to caution of heart failure risks. The agency said the risks especially apply to those who already suffer from cardiovascular or kidney disease.

In its Drug Safety Communication, the FDA stated: “Health care professionals should consider discontinuing medications containing saxagliptin and alogliptin in patients who develop heart failure and monitor their diabetes control. If a patient’s blood sugar level is not well-controlled with their current treatment, other diabetes medicines may be required.”

The FDA also noted patients should monitor for symptoms of heart failure, which can include:

  • Tiredness
  • Weakness
  • Fatigue
  • Shortness of breath
  • Trouble breathing
  • Weight gain or swelling

However, they cautioned that patients should not stop taking their medication without talking to their doctor first.

Recently, lawyers began filing lawsuits on behalf of those who have suffered heart failure while taking Onglyza. Due to the popularity of the drug, it is expected that hundreds or more may eventually seek compensation from the manufacturer.

If you or a loved one were affected by heart failure after taking Onglyza, contact DrugNews today to speak directly with a lawyer at no cost.



Tucker, M. FDA Warns of Heart-Failure Risk With Two Diabetes Drugs. MedScape. (April 5, 2016). Retrieved from www.medscape.com

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