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FDA Reviews AstraZeneca Drug due to Heart Risk Concerns

Justin Chavez3 years ago

The U.S Food and Drug Administration has decided to review the potential heart risks associated with AstraZeneca Plc's widely-used diabetes drug saxagliptin, which is marketed as Onglyza and Kombiglyze.

According to Reuters, the FDA requested the data from clinical trials after the New England Journal of Medicine (NEJM) published its findings on a recent study that showed a small rise in hospitalizations due to heart failure among patients using the drug.

What is Saxagliptin?

  • Saxagliptin is used in combination with diet and exercise to lower blood sugar in adults with type 2 diabetes. 
  • The drug works by increasing the amount of insulin produced by the body after meals. 
  • Type 2 diabetes is a disease in which there is a high level of sugar in the blood as the body does not make or properly use the insulin hormone. 

About the FDA's Decision to Review Saxagliptin

The study was published by NEJM in September and was based on a study supported by AstraZeneca and Bristol-Myers Squibb Co. The study did not find an increase in the rate of deaths or major cardiovascular risks (such as heart attacks and strokes), in patients who used saxagliptin. 

The FDA considers the information in the study so far to be preliminary and say that healthcare professionals should continue to prescribe the drug. The FDA has requested the trial data to be submitted by March, with their analyzation to follow. 

According to the FDA, the review of the drug in question is part of a broader evaluation of all type 2 diabetes drugs and cardiovascular risks. 

Side Effects of Saxagliptin

The following are possible side effects of saxaglitpin:

  • Nausea
  • Hypoglycemia
  • Pneumonia
  • Pulmonary Edema
  • Pancreatitis
  • Renal Injury 


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