Januvia Evaluation Criteria

Lawsuit Focus – Drug Injury

JANUVIA, a once-daily prescription pill that helps lower blood sugar levels in adults with type 2 diabetes – increases the risk of pancreatitis (inflammation of pancreas)

Primary Injury: Pancreatitis (fatal and non-fatal hemorrhagic and necrotizing pancreatitis)

Other Injuries: Cutaneous vasculitis, hypersensitivity reactions, angioedema, kidney problems

Selected Risk Information about JANUVIA (as published by Merck)

Serious side effects can happen in people who take JANUVIA, including pancreatitis, which may be severe and lead to death. Before you start taking JANUVIA, tell your doctor if you’ve ever had pancreatitis. Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Januvia Case Evaluation Criteria:

1. Whether the patient was prescribed Januvia? Reason for prescription?

2. Did the patient have any preexisting conditions, allergies or contraindications for the Januvia? – Particularly any history of pancreatic disease

3. Dosage and Intake details (to be included under pharmacy log)

  • Critical Review of Physician Drug Prescription Details
  • Pharmacy Dispensing Details
  • Pharmacy Refill Details
  • Details of Pharmacy Dispensing Details are taken as Confirmatory

4. Did the patient develop pancreatitis after Januvia intake?

5. When and where was the pancreatitis diagnosed?

6. Treatment/management –procedures, indications, complications, pathology and findings

7. Follow-up visits for pancreatitis treatment/management – Did the condition resolve?

8. Outcome/prognosis – any diagnosis of pancreatic cancer?

9. Any recurrence of pancreatitis

10. Any medical/surgical history, social history (smoking) that could have had an effect on the injury

Symptoms of pancreatitis include:

  • Abdominal pain, especially a dull ache in upper abdomen
  • Pain may be felt going from your abdomen through to your back
  • Fatty and pale-colored stools
  • Fever
  • Loss of appetite
  • Jaundice
  • Nausea, vomiting

Contraindications/who should not take Januvia?

People with pancreatitis

Missing Record Communication:

Identify and report on missing medical records/pharmacy bills

Apart from identifying critical missing records that are important for the case, provide a detailed outline on what records are needed, why we need them, how did we get a clue that these records are missing and whether the records missing are confirmatory/probable. This will also help in following up and retrieving the records.

Missing Records are presented in the following format

Capture