Januvia

  • Januvia Medical Record Review & Outsourcing Services

Januvia (Sitagliptin) is an oral antidiabetic medicine belonging to class dipeptidyl peptidase-4 (DPP-4) inhibitor, manufactured by Merck & Co.,  was approved by the U.S. Food and Drug Administration (FDA) in 2006. In 2007, the FDA approved a variation of Januvia called Janumet, which is a combination of sitagliptin and metformin and is also made by Merck.

Sitagliptin is an anti-diabetic drug that works by increasing the levels of natural substances called incretins. Incretins help to control blood sugar by increasing insulin release, especially after a meal. They also decrease the amount of sugar your liver makes. It works by regulating the levels of insulin your body produces after eating.

Serious Alleged Injuries may include:

  • Pancreatic Cancer
  • Thyroid Cancer
  • Acute Pancreatitis
  • Hemorrhagic Pancreatitis
  • Necrotizing Pancreatitis
  • Severe Joint Ache

FDA SAFETY WARNINGS:

In 2011, the FDA received almost 200 reports of acute and chronic pancreatitis linked to Januvia some of which were fatal. In 2015, the FDA warned Januvia (and Janumet) could cause severe joint pain. The most serious injuries associated with Januvia are acute pancreatitis, pancreatic cancer, and thyroid cancer.

In June 2015, the FDA warned that the type 2 diabetes medicines Sitagliptin (and saxagliptin, linagliptin, and alogliptin) may cause joint pain, which can be severe and disabling. The FDA has added a new Warning and Precaution about this risk to the labels of all medicines in the DPP-4 inhibitors.

Lawsuit Allegations:

Lawsuits against the makers of Type 2 diabetes drugs Januvia and others were consolidated in MDL No. 2452 in California federal court. Allegations include that the drug manufacturers failed to warn about the risk of pancreatic cancer and pancreatitis.

In November 2015, Judge Anthony J. Battaglia under a motion called summary judgment granted the manufacturer’s request to dismiss all the cases in the MDL. AT this time 749 cases were pending in the MDL.

In September 2016, plaintiff’s attorneys filed an appeal on behalf of the MDL, stating that Battaglia misinterpreted the U.S. Supreme Court preemption law.

The Ninth Circuit has not yet returned the decision. The count of cases as of April 15, 2017, was near to 1000. Thus, the fate of the plaintiffs is now in the hand of U.S. Court of Appeals for the Ninth Circuit.

Evidences:

  • Usage of Januvia
  • Duration of Usage
  • Indication of Usage in Medical and Pharmacy Records
  • Complications and their treatment after intake

Medical Record Review and claim validation of Januvia 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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