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Case studies 1~4 of ADR events

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I would like to show you some adverse drug reaction case series. Starting with this one, a 86 year old female. She developed extrapyramidal symptom (EPS), such as hand tremor, oral tremor with drooling, and trunk rigidity. She was developed Intermittent hallucination and conscious disturbance since 2011/3/18. Doctor switched from quetiapine to Risperidone (Risperdal®) oral solution 1mg/ml 30 ml/bot, 0.5 mL PO QN on 2013/2/1. Shortly after, patient had hand tremor, oral tremor with drooling, and trunk rigidity after the first dose of risperidone. Her daughter reduced the dose of Risperidone to 0.4 mL every night without doctor’s permission on the next day, but the patient still experienced EPS. Her daughter stopped the risperidone and brought her to ER on 2013/2/3.
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Under the impression of subacute delirium, risperidone was discontinued on 2013/2/4. The EPS was finally alleviated, and the patient was able to walk coordinately on 2013/2/7. The patient responded to Risperidone in a dose-independent manner since the change of dose on 2/2 and did not relieved EPS. Her renal function and liver function considered as normal during initiate risperidone. Other relevant data included the Impression was subacute delirium. Personal history that she quit Smoking for 30 years, she did not drink alcohol and she did not allergy to any food or drug. She was diagnosed with Alzheimer’s disease since 2009 and coronary artery disease.
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The suspicious drug related to EPS was Risperidone(Risperdal) 1mg/mL, 30 mL/bot 0.5 mL PO every night from 2013/2/1 to 3 due to senile dementia with delusional features She was taking other drug concurrently. As following Isosorbide mononitrate(Ismo) 20 mg PO every day from 2013/1/31-2/7 due to her CAD. Memantine(Witgen) 10 mg 0.5 tablet PO BID from 2013/12/13 up to present and Donepezil/Aricept 10 mg PO QD from 2013/12/13 up to present both for Alzheimer’s disease. We looked up Lexi-comp and found out risperidone is associated with Parkinsonism and the rate of adverse reaction is around 12% to 20% in adult population. Let us quickly go over some other cases.
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This is a 28 year-old male with Relapsed right proximal femur osteosarcoma under Ifosfamide 4274 mg IV QD, etoposide 106 mg IV QD from 2017/5/27 to 5/30. This is also a second line palliative chemotherapy. He developed febrile neutropenia with fever 38.6 ℃ on 2017/6/8. His WBC was down to 100 and Absolute neutrophile count was down to 6.7. A Severe neutropenia case. The assessment was to rule out Ifosfamide and etoposide related febrile neutropenia. The incidence rate of febrile neutropenia is around 1%. And, the plan was to prescribed G-CSF® 300 mcg Subcutaneous stat, Tazocin 4.5 g IV every 6 hours, and exacin 400 mg IV every day for 7 days.
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Next, This is a 58 year old female with Lung adenocarcinoma T1N3M1 with multiple bone metastasis and brain metastasis under Cisplatin 75 mg IV stat on 2016/4/8 and 4/29. Urticaria over face and limbs was observed on 2016/4/29. Her BUN was 15, Scr was 0.74, WBC was 3100, Platelet was 148000, Eosinophil was 2.1%. The assessment was to rule out Kemoplat® (cisplatin) related allergic reaction. The plan was to prescribed desloratadine 5 mg PO QD, fexofenadine 60 mg PO BID, chlorpheniramine 5mg IV stat, hydrocortisone 200 mg IV stat, prednisolone 5 mg 2 tablets PO BID with meal. We re-challenged Kemoplat® (cisplatin) on 2016/5/27, Unfortunately, skin rash and angioedema was observed again. Later, on 2016/7/15 we finally shift to paraplatin (carboplatin) for this patient.
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Case 4, This is a 87 year-old female with Osteoporosis under Fosamax® PLUS 1 tab every week before meal from 2012/3/16 to 2016/1/4. Fosamax® PLUS is a triple combination of alendronate plus calcium supplement and cholecalciferol (vitamin D3). The patient complained of poor healing after dental extraction since 2015 on outpatient clinic visit dated 2016/5/25. Her Dexa on limbs showed T-score Left and Right was -3.5 and -3.2 on 2012/3/13. And, her Creatinine was 1.38 on 2015/10/22. The assessment was to rule out Fosamax related osteonecrosis of jaw. The plan was to prescribed Augmentin 1 g PO every 12 hours. The patient received sequestrectomy operation on 2016/6/22 and 8/25. The biopsy from 2016/6/22 showed necrotic bone tissue and bacterial colonies.
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And, biopsy from 8/26 showed sequestrum.

Ms Chao explains how she and her colleagues analyze and resolve ADR events using case study 1. She also gives 3 more examples of ADR events.

The first case

An 86-year-old female developed extrapyramidal symptom (EPS) shortly after 0.5mL of 1mg/ml Risperidone administration on 2013/2/1. Her daughter reduced the dose of Risperidone to 0.4 mL every night without doctor’s permission on 2013/2/2, but EPS persisted. She visited the ER 2 days after the first administration.

Under the impression of subacute delirium, risperidone was discontinued on 2013/2/4. EPS finally alleviated.

Below are some of the relevant information:

She responded to Risperidone in a dose-independent manner since the change of dose on 2/2 and did not relieved EPS.

Her renal function and liver function considered as normal during initiate risperidone administration.

She quit smoking for 30 years, does not drink and has no food/drug allergies.

The pharmacists looked up Lexi-comp and found out risperidone is associated with parkinsonism and the rate of adverse reaction is around 12% to 20% in adult population, thus explaining this case.

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