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Andrew D'Arcy
Andrew D'Arcy
Attorney • (609) 641-6200

ONGLYZA – POSSIBLE INCREASED RISK OF HEART FAILURE

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AstraZeneca’s prescription medication Onglyza, used in the treatment of Type 2 diabetes, may cause an increase in certain cardiovascular events, and could even result in death.  Onglyza received FDA approval on July 31st, 2009, and is used to help control high blood sugar in patients with Type 2 diabetes (who do not suffer from diabetic ketoacidosis).

The FDA in April 2016 issued a drug safety communication, adding warnings about heart failure risks to labels of type 2 diabetes medicines containing saxagliptin and alogliptin.  The FDA wrote in its warning “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.”

A federal lawsuit filed recently claims that drug manufacturers failed to warn consumers of heart attack risks associated with the drug.  Texas resident Wrendell Chester filed the lawsuit claiming that he suffered congestive heart failure, heart failure and hypoxic respiratory failure, a condition where there is not enough oxygen in the blood, after he took both Onglyza and XR (saxagliptin and metformin extended release) between 2010 and 2015.

Soon after its release, experts worried about the potential link between Onglyza and heart failure.  A study conducted in late 2013 may have justified that concern.  Research funded by the manufacturers found that patients given Onglyza were more likely to be hospitalized for heart failure than those not given the drug.  That study’s findings led to the FDA launching an Onglyza safety investigation in February 2013.  On April 4, 2016, the FDA announced the findings of its review, determining that Onglyza and similar diabetes drugs should carry new label warnings that the drug was linked to a higher than expected risk of hospitalization for heart failure and all-cause mortality.

The FDA recommends patients taking Onglyza contact a health care professional immediately if they develop heart failure symptoms, which can include:

  • Unusual shortness of breath
  • Problems breathing when lying down
  • Fatigue or weakness
  • Weight gain involving swelling of the ankles, feet, legs or stomach

Medications such as Onglyza are designed to improve the lives of patients who use them but in some cases, the medications end up causing more harm than good.  If you or a loved one has suffered medical injury after taking Onglyza, you may be eligible for compensation.