Onglyza

  • Onglyza Medical Record Review & Outsourcing Services

Onglyza (saxagliptin) belongs to drug class dipeptidyl peptidase-4 (DPP-4) inhibitor; it was approved by the U.S. Food and Drug Administration (FDA) on July 31, 2009. The drug was initially developed by Bristol-Myers Squibb; this was followed by AstraZeneca joining with Bristol-Myers Squibb in 2007 to co-develop the product and collaborating on the marketing front as well. Onglyza is prescribed for the treatment of Type-2 diabetes to be used along with diet and exercise to lower blood sugar in adults. 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.

Saxagliptin is not used to treat type 1 diabetes (condition in which the body does not produce insulin which results in uncontrolled  sugar amount in the blood not ) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). The doctor may want the patient to stop taking saxagliptin for a short time if they become ill, have a fever or infection, or if they have surgery or a medical emergency. Saxagliptin is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly other medications.  It comes in the form of a tablet to take by mouth. Onglyza is supplied as a 5 mg and 2.5 mg tablet designed for oral administration. It is usually taken once a day with or without food.

D-PP4 inhibitors are a class of compounds that work by affecting the action of natural hormones in the body called incretins. Incretins decrease blood sugar by increasing consumption of sugar by the body, mainly through increasing insulin production in the pancreas, and by reducing production of sugar by the liver. Although Saxagliptin controls type 2 diabetes, it does not cure it. The physician is also to be informed in case the patient suffers from kidney disease or is on dialysis.

Studies conducted showed that people on Onglyza medication had 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:

  • 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.”

  • 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.

  • April 5, 2016: The FDA issued Onglyza warning stating the addition of a heart disease and heart failure warning to the drug’s label. 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.

  • February 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).

Legal Updates:

Defendants: Bristol-Myers Squibb Company, AstraZeneca Pharmaceuticals LP, IPR Pharmaceuticals, and McKesson Corporation are the defendants named in this litigation.

Defense Law Firm: Bristol-Myers Squibb and McKesson are represented by Phyllis A. Jones of Covington & Burling LLP. AstraZeneca is represented by Donald F. Zimmer Jr. of King & Spalding LLP.

Allegations: All lawsuits revolve around the common allegation that the drug maker knew or should have known about the link between Onglyza and heart failure for years, yet failed to adequately warn users and the medical community.

Plaintiffs' Steering Committee:

  • Raymond Boucher - Boucher LLP

  • Frank M. Petosa - MORGAN & MORGAN

  • Erin Copeland - FIBICH, LEEBRON, COPELAND & BRIGGS

  • Jerome P. Prather  - GARMER & PRATHER

  • Yvonne M. Flaherty - LOCKRIDGE GRINDAL NAUEN PLLP

  • Steven Teppler - ABBOTT LAW GROUP

  • Jennifer Lenze - LENZE LAWYERS

  • Matthew L. White - GRAY & WHITELAW

  • Kim Loutey - KENNERLY LOUTEY

Lawsuit Status:

  • February 2018: MDL No.: 2809-In Re: Onglyza and Kombiglyze XR Products Liability Litigation was established for coordinated pretrial proceedings in the U.S. District Court for the Eastern District of Kentucky under District Judge Karen K. Caldwell. Approximately 80 Onglyza and Kombiglyze lawsuits were a part of this docket.

  • June 2018: As per the JPML's report on pending MDL dockets, nearly  200 lawsuits remain pending in the Eastern District of Kentucky for the drugs Onglyza and Kombiglyze XR.

  • November 2018: Judge Caldwell announced the bifurcation of Onglyza heart failure cases by establishing two phases for discovery, with the first focusing on general causation and whether plaintiffs can establish that the diabetes drug causes heart failure.

  • Onglyza lawsuits alleging heart failure whose plaintiffs are California residents have remained in state superior court under Judge Curtis E.A. Karnow—specifically Case No. CJC-16-004909 .

Important Verdicts & Settlements

Proposed bellwether trials in October 2020

Evidence:

  • 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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