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
Case Evaluation Criteria:
- Whether the patient was prescribed Benicar? Reason for prescription? (Hypertension)
- Was the patient using other antihypertensives prior to being placed on Benicar?
- Did the patient have any preexisting conditions, allergies or contraindications for Benicar?
- Dosage and Intake details (to be included under pharmacy log)
- What was the injury due to Benicar? (enteropathy, diarrhea, dehydration, malnutrition)?
- Was Benicar discontinued? Details of other hypertensive medications prescribed?
- When and where was the injury diagnosed? Whether hospitalized? Dates of hospitalization.
- Treatment/management. Any complications
- Follow-up visits for treatment/management of injury.
- Future anti-hypertensive therapy/type/medication name.
- Outcome/prognosis. Resolution of injury?
- Medical History of Hypertension, Heart Diseases
Necessary Pharmacy Information:
- Physician Drug Prescription Details
- Pharmacy Dispensing Details
- Pharmacy Refill Details
- 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