Benicar – Emerging Litigation

Benicar (Olmesartan Medoxomil) is an Angiotensin II Receptor Blocker (ARB) used to treat high blood pressure. This drug is known to cause severe gastrointestinal problems i.e. sprue-like enteropathy, chronic diarrhea, weight loss, malnutrition and intestinal atrophy.

FDA approved label changes to include intestinal problems (sprue-like enteropathy) linked to Benicar. FDA is continuing to evaluate the safety of Olmesartan-containing products.

Lawsuit & Injury Focus:

Failure to warn patients of side effects of Benicar i.e. severe intestinal problems

Serious and Life-threatening Side Effects of Benicar including:

  • Sprue-Like Enteropathy
  • Severe, chronic diarrhea
  • Substantial weight loss
  • Intestinal villous atrophy (on biopsy of intestines) leading to malnourishment
  • Dehydration

Case Evaluation Criteria:

  1. Whether the patient was prescribed Benicar? Reason for prescription? (Hypertension)
  2. Was the patient using other antihypertensives prior to being placed on Benicar?
  3. Did the patient have any preexisting conditions, allergies or contraindications for Benicar?
  4. Dosage and Intake details (to be included under pharmacy log)
  5. What was the injury due to Benicar? (enteropathy, diarrhea, dehydration, malnutrition)?
  6. Was Benicar discontinued? Details of other hypertensive medications prescribed?
  7. When and where was the injury diagnosed? Whether hospitalized? Dates of hospitalization.
  8. Treatment/management. Any complications
  9. Follow-up visits for treatment/management of injury.
  10. Future anti-hypertensive therapy/type/medication name.
  11. Outcome/prognosis. Resolution of injury?
  12. Medical History of Hypertension, Heart Diseases

Necessary Pharmacy Information:

  1. Physician Drug Prescription Details
  2. Pharmacy Dispensing Details
  3. Pharmacy Refill Details
  4. Details of Pharmacy Dispensing Details are taken as Confirmatory

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

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