Onglyza

  • Onglyza

Onglyza (saxagliptin) belongs to the 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 blood sugar without causing any weight fluctuations.

Saxagliptin is not used to treat type 1 diabetes (a 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 the consumption of sugar by the body, mainly through increasing insulin production in the pancreas, and by reducing the 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.

Safety Announcement As Made By The FDA

  • Patients taking these medicines should contact their health care professionals right away if they develop signs and symptoms of heart failure such as:
  1. Unusual shortness of breath during daily activities
  2. Trouble breathing when lying down
  3. Tiredness, weakness, or fatigue
  4. Weight gain with swelling in the ankles, feet, legs, or stomach
  • Patients should not stop taking their medicine without first talking to their health care professionals.
  • FDA has added warnings about the risk of hospitalization for heart failure to the labels of saxagliptin- and alogliptin-containing type 2 diabetes medicines (see List of saxagliptin or alogliptin-containing Medicines). Heart failure occurs when the heart cannot pump enough blood to meet the body’s needs.
  • Before taking saxagliptin or alogliptin, tell your health care professional if you have a history of heart failure or kidney impairment, as an increased risk of hospitalization for heart failure was found in clinical trials that included patients with these medical issues.
  • Do not stop taking your saxagliptin or alogliptin medicine without first talking to your health care professional.
  • Contact your health care professional right away if you develop signs and symptoms of heart failure when taking saxagliptin or alogliptin, such as:
  1. Unusual shortness of breath during daily activities
  2. Trouble breathing when lying down
  3. Tiredness, weakness, or fatigue
  4. Weight gain with swelling in the ankles, feet, legs, or stomach
  • Read the patient Medication Guide you receive with your prescriptions. It explains the benefits and risks associated with the use of the medicine.
  • Talk to your health care professional if you have any questions or concerns about saxagliptin or alogliptin.
  • Report side effects from saxagliptin, alogliptin, or other medicines to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.

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 Legal Proceedings, Verdicts & Settlements:

October 2017: The U.S. Judicial Panel on Multidistrict Litigation was approached by a group of Plaintiffs to centralize Onglyza cases in a single federal court.

January 2018: The JPML decided to hear oral arguments on January 25, 2018, to determine whether consolidation was necessary or not. 

February 2018: The U.S. Judicial Panel on Multidistrict Litigation gave a nod for centralization of all the federally-filed Onglyza and Kombiglyze XR lawsuits in a single U.S. District Court, Eastern District of Kentucky.

March 2018: Onglyza MDL witnessed a steady rise in the number of lawsuits with more than 80 product liability lawsuits already pending in the federal court.

October 2018: The federal court presiding over the multidistrict litigation constituting hundreds of heart failure lawsuits linked to Onglyza or Kombiglyze XR medication, allowed new plaintiffs to directly file a case in the MDL.

October 2018:  Onglyza drugmaker AstraZeneca asked Judge Karen Caldwell to follow a phased pretrial schedule by giving priority to the "general causation" issue of whether the diabetes medication causes heart failure before proceeding with the case-specific discovery.

January 2019: The federal court issued a Case Management Order to regulate the production of Plaintiff Profile Forms.  

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.

We are social:

Accreditations

NSIC - CRISIL

NSIC-CRISIL has assigned a "SE 2A" rating to Neural IT, indicating a company with High Performanc...

ISO 27001 Certification

Neural IT is officially ISO 27001:2013 (ISO 27001) certified by Alcumus ISOQAR Limited as the Cer...

HIPAA

Neural IT has successfully implemented HIPAA for securing Health records....

Associations

NYSTLA

NYSTLA - "Neural IT is proud to be associated with NYSTLA (New York State Trial Lawyers Associati...

CAOC

CAOC - "Neural IT is proud to be associated with CAOC (Consumer Attorneys of California) as a Ven...

CAALA

CAALA - "Neural IT is proud to be associated with CAALA (Consumer Attorneys Association of Los An...

News & Events

Friends Of CAALA 2020
It is a treasured moment for Neural IT to be associated as an Affiliate Member for so many years and receive an…
sharing-smiles-sharing-happiness-on-national-smile-day-event-neural-it
Amidst the chaos of COVID-19 pandemic, we have something to cheer about as today is National Smile Day, and a smile is…
Happy Mother's Day from Neural IT
The cagey pandemic has halted our lives, but the only spirits that kept igniting during the crisis are the ones whom we…

Latest Tweets