Onglyza

  • Onglyza Medical Record Review & Outsourcing Services

Onglyza (saxagliptin) is a DPP-4 inhibitor, manufactured by AstraZeneca and approved by the U.S. Food and Drug Administration (FDA) on July 31, 2009, for the treatment of Type-2 diabetes. Saxagliptin helps the pancreas to secrete more insulin and stops the liver from making excess sugar. Onglyza effectively controls the blood sugar without causing any weight fluctuations.

There were studies conducted which showed that people on Onglyza medications have a higher risk of pancreatic cancer and increased risk of hospitalization due to heart failure; thus, the medication has ended up causing more harm than benefit to diabetic patients.

Serious Alleged Injuries may include:

  • Pancreatic cancer
  • Acute pancreatitis inflammation)
  • Severe Joint Pain
  • Thyroid cancer
  • Heart failure
  • Death

FDA SAFETY WARNINGS:

  • On March 14, 2013, the FDA issued a drug safety communication that it was evaluating unpublished findings by researchers that linked Onglyza and other diabetes drugs with pancreatitis and cellular changes called “pancreatic duct metaplasia.”
  • On February 11, 2014, the FDA issued another drug safety communication, warning of an increased rate of hospitalization for saxagliptin users due to heart failure compared to nonusers of the drug.
  • The FDA issued a warning on April 5, 2016, stating that there was an increased risk of heart failure caused by Onglyza. This warning was particularly important for people who were heart patients or had kidney problems. The SAVOR clinical studies further supported the warnings stating that there was a 27% increased risk of heart failure linked to Onglyza.
  • In March 2017, AstraZeneca announced that the FDA gave an approval to Qtern, a once-daily oral fixed dose medication for treating type 2 diabetes in adults. Qtern is a combination of 5 mg of DPP-4 inhibitor saxagliptin (Onglyza) and 10 mg of SGLT2 inhibitor dapagliflozin (Forxiga/Farxiga).

Lawsuit Allegations:

Bristol-Myers Squibb and AstraZeneca are facing lawsuits where plaintiffs allege failure to warn doctors and patients about the side effects, that the drugmakers did not properly test the drug before selling it and used deceptive marketing practices. Onglyza litigations are still in the early stages, and there are no class actions or multidistrict litigation (MDL) formed yet though a request was made as of October 2017. Several cases are filed in various state courts across the country including Texas, Kentucky, and Illinois. California is the state with the most pending lawsuits, followed by Kentucky, Texas, and Illinois.

Suits were refiled in New Jersey in February 2017, these were originally filed in California in September 2016. The 14 suits filed in New Jersey allege that Onglyza was sold in 2009 without conducting the clinical trials suggested in the FDA’s 2008 guidance.

Evidences:

  • Usage of Onglyza in Medical and Pharmacy Records
  • Duration of Onglyza usage in medical records
  • Proof of injury and Treatment provided for injuries

Medical Record Review and claim validation of Onglyza case should take approximately 3 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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