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U.S. Department of Health and Human Services

Case Study 1 – Drug

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Helen H. is a 70-year-old housewife, married, with three children, and living with her husband. On January 1, she called her family physician of 20 years, Dr. Smith, complaining of a 3-day history of severe mid-abdominal pain, and was sent to the emergency room to be seen immediately. On examination, the diagnosis of acute pancreatitis was made based on both physical findings and lab work including an amylase of 1034 and lipase markedly elevated at 8031. Additional admitting diagnoses included renal failure with dehydration and acidosis. She was given IV fluids for rehydration and placed on telemetry.

Further testing included a computed tomography (CT) scan of the abdomen on January 2 showing mild pancreatitis and a fatty liver. Upper Gastrointestinal endoscopy on January 11 demonstrated only a dilated bile duct without choledocholelithiasis.

Helen has had rheumatoid arthritis for about 25 years and was stabilized and managed on prednisone 7.5 mg once daily (qd) and sulfasalazine EC 1500 mg twice daily (bid). She recently started taking XYZ Pharmaceutical’s new disease-modifying antirheumatic drug (DMARD) on November 27 and had been taking 20 mg daily for the 5 weeks prior to hospitalization. Past medical history also included diagnoses of obesity and hypertension. She was also taking atenolol, norvasc, folic acid, pantoprazole and felodipine. Allergies: penicillin – causes rash, compazine-altered sensorium. During her hospital stay her current medications, including the DMARD, were discontinued. She received IV fluids and advanced to full oral intake without difficulty.

Dr. Smith suspects an association between the recent use of the DMARD and the patient’s pancreatitis.

A. Patient Information


3. Sex

4. Weight

or

B. Adverse Effects, Product Problem or Error

1. Check all that apply: (?HelpUseful TipThe HIPAA Privacy Rule specifically permits pharmacists, physicians, nurses, or hospitals (i.e. covered entities) to report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.)


(?HelpUseful Tip A good quality adverse event case report includes the following elements: clinical outcome and actions taken with the suspected product(s); time to the event onset; detailed description(s) of the adverse event(s) [Section B5]; results of any laboratory or diagnostic medical imaging [Section B6]; medical history [Section B7]; date of initiation of the suspected product [Section D3]; list of suspected and/or concomitant drugs or devices [Section F]; and patient demographics )
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Patient was started on XYZ 11/27/2006. In late December she began to have abdominal pain. She was admitted to the hospital for life threatening acute pancreatitis. Her initial amylase was 1034 and lipase 8031. She was admitted to telemetry for dehydration, renal failure and acidosis. Her medications were discontinued and she improved with hydration. XYZ was the only new mediation she had taken that month. She was on chronic steroids and abc which have also been associated with pancreatitis but she had been on a stable dose of these medications for 3 yrs.

C. Product Availability

Product Available for Evaluation? (Do not send product to FDA)

D. Suspect Product(s)

E. Suspect Device


5. Operator of Device


8. Is this a Single-use Device that was Reprocessed and Reused on a Patient?

F. Other (Concomitant) Medical Products

G. Reporter



2. Health Professional?
4. Also Reported to:
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