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
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:
- Hypomagnesemia – Low magnesium levels symptoms including tetany, arrhythmias, seizures, tremors, muscle weakness, dizziness, spasms,
- C. Difficile Diarrhea, Headache, Nausea, abdominal pain, dry mouth
Identify and report cases with the following scenarios:-
- No Injuries: Patient took Nexium but did not develop any injuries.
- No Nexium intake: Patient was not given Nexium but a different drug – Hold review and communicate to client.
- Nexium only for short period – Nexium taken only for a short period of time (less than one year) and also no characteristic injury
- 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