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FDA Rejects AstraZeneca’s Onglyza Combo Drug

FDA Rejects AstraZeneca’s Onglyza Combo Drug

AstraZeneca, the manufacturers of Type 2 diabetes drug Onglyza, has had its application for a new combo drug turned down by the U.S. Food and Drug Administration (FDA). The FDA says that the two drugs Forxiga and Onglyza have not been investigated enough to determine the risks involved with the combination of the two.

The FDA Needs More Clinical Data

On October 16, 2015, the FDA denied AstraZeneca’s application for a new combination diabetes drug. Although both of the drugs involved in the combination, Onglyza (saxagliptin) and Forxiga (dapagliflozin) are currently approved by the FDA, there is not enough known about how a combination of the two drugs will affect the human body. The FDA has stated that it needs more clinical data in order to determine the safety and effectiveness of the new drug combo. AstraZeneca has stated that they are committed to developing the drug combo and taking the necessary steps to receive FDA approval.

Risks Involved with Onglyza

One half of the proposed combo drug is called Onglyza. However, several studies have shown that Onglyza may cause a wide variety of serious and potentially life-threatening conditions. These include:

  • Pancreatitis
  • Pancreatic cancer
  • Thyroid cancer
  • Heart failure
Risks Involved with Forxiga

The other half of AstraZeneca’s combo drug is known as Forxiga, which is part of a class of drugs called SGLT2 inhibitors. This class of drugs has been associated with the following significant dangers:

  • Kidney impairment
  • Kidney failure
  • Urinary tract infections
  • Bone problems
  • Diabetic ketoacidosis (DKA)

Contact an Onglyza Attorney

AstraZeneca is a drug company that focuses on making the biggest profits possible, while disregarding the health and safety of the patients taking their drug. The company attempted to get FDA approval for their combination drug without conducting proper clinical trials to examine the risks involved. Their FDA-approved diabetes drug Onglyza has already caused serious illnesses and even death in many patients across the country, and now they wish to make more profits off of a new combo drug. It’s time to stand up to the manufacturer and hold them accountable for their wrongdoings. If you’ve been hurt by Onglyza, contact us today by filling out our free case evaluation or by calling us at 888-595-2922.