Nexium Case Evaluation Criteria

Lawsuit Focus – Drug Injury

  • Proton Pump Inhibitor Drug used for treating Acid Reflux, Heart Burn, Peptic Ulcer, GERD, Erosive Esophagitis
  • Risk of Bone Fractures: Patients taking multiple daily doses for a long period (> one year) are at increased risk for osteoporosis-related fractures of the hip, wrist or spine.

Areas to be focused in Medical Records Review

1.       Whether the patient was prescribed Nexium? Reason for prescription? (Heart burn, GERD, peptic ulcer)

 2.       Was the patient using other proton pump inhibitors or antacids prior to Nexium? (Omeprazole, Ranitidine, Gelusil)

 3.       Patient with known hypersensitivity to Proton Pump Inhibitors?

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


Prescription PPI vs Over-the-Counter (OTC) PPI

Physician Prescription Details

Pharmacy Dispensing Details, Pharmacy Refill Details

(Pharmacy Dispensing Details are taken as Confirmatory)

 

Was Nexium stopped after injury?

Nexium Intake for more than one year before the date of injury

Injuries, Complications due to Nexium

Fractures:

Age of the patient – > 50 year old, Old Women, Post-Menopausal

Prior History of Osteoporosis, Fractures, Treatment of fractures, Smoking History

Fracture Risk – Bone Density study etc

Cause of Fracture?

Fall – complications after fall/fracture, treatment and management

Follow up visits

Impact on ADLs, Future Prognosis

 Nexium with Plavix – Reduces effectiveness of Plavix (anti-coagulant) – higher risk for heart attack, stroke

Other Side Effects:

  1. Hypomagnesemia – Low magnesium levels symptoms including tetany, arrhythmias, seizures, tremors, muscle weakness, dizziness, spasms,
  2. C. Difficile Diarrhea, Headache, Nausea, abdominal pain, dry mouth


Special Focus

Identify and report cases with the following scenarios:-

  1. No Injuries: Patient took Nexium but did not develop any injuries.
  2. No Nexium intake:  Patient was not given Nexium but a different drug – Hold review and communicate to client.
  3. Nexium only for short period – Nexium taken only for a short period of time (less than one year) and also no characteristic injury
  4. Over the Counter PPI taken only for a short period (14 days) – Report to Client


Identify and report on missing medical records/pharmacy bills

Nexium use details missing

Nexium Injury details missing

Nexium injury treatment details missing


Quick MD (Gastroenterologist) and MD Ortho Specialist Opinion relating to PPI intake and the fracture complications (if needed)

Nexium FDA Release

 

Nexium Product Literature

 

 

 

 

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