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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 575 journals)
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Drug Safety - Case Reports
Journal Prestige (SJR): 0.216
Number of Followers: 2  

  This is an Open Access Journal Open Access journal
ISSN (Print) 2199-1162 - ISSN (Online) 2198-977X
Published by Springer-Verlag Homepage  [2467 journals]
  • Acknowledgement to Referees

    • PubDate: 2019-11-16
      DOI: 10.1007/s40800-019-0107-6
  • Acute Kidney Injury Following High-Dose Methotrexate Administration in a
           Day Care Hospital

    • Abstract: Abstract Day care is a potential alternative to inpatient care of cancer patients. Using day care reduces medical costs substantially compared to inpatient care, which is driving the transfer of many inpatient chemotherapy protocols to day care hospitals (DCHs). However, in contrast to inpatient management, day care provides limited observation time, which could increase the risk of renal toxicity when using these protocols. We present a case report of acute kidney injury following high-dose methotrexate administration in a DCH. Based on a review of the current literature on acid-base balance, we also discuss appropriate patient selection and judicious hydration and urine alkalinization so as to prevent toxicity in the day care setting.
      PubDate: 2019-11-12
      DOI: 10.1007/s40800-019-0106-7
  • Fournier’s Gangrene in a Patient with Type 2 Diabetes Mellitus Treated
           with Empagliflozin: A Case Report

    • Abstract: Abstract Sodium-glucose cotransporter-2 (SGLT2) inhibitors have been reported as possibly associated with Fournier’s gangrene (FG). This case report describes a 34-year-old Japanese man who was diagnosed with FG after the administration of empagliflozin for type 2 diabetes mellitus (T2DM). He presented with pain and swelling in the perineum and groin 142 days after initiating empagliflozin. The clinical features, laboratory data, and computed tomographic findings were consistent with FG. Surgical drainage and debridement of necrotic tissues were performed immediately after admission to our hospital. The patient had no complications of diabetes before the onset of FG. Glycemic management was good at the time of FG onset. This case suggests a possible association between empagliflozin and FG. We report a case of FG in a patient during a period of good glycemic management following treatment with empagliflozin. We recommend further awareness of this relationship and suggest the need for additional research.
      PubDate: 2019-10-18
      DOI: 10.1007/s40800-019-0105-8
  • A Case of Oropharyngeal Angioedema Following Intravenous Recombinant
           Tissue Plasminogen Activator (rt-PA) and Mechanical Thrombectomy

    • Abstract: Abstract A 72-year-old housewife presented with ischemic cerebrovascular stroke. Intravenous thrombolysis using recombinant tissue plasminogen activator (rt-PA) followed by mechanical thrombectomy under general anesthesia were attempted. The patient developed stridor and tongue swelling, in addition to hypotension and bradycardia, 60 min after completion of the rt-PA infusion. The airway was intubated, and intramuscular adrenaline, together with intravenous hydrocortisone and diphenhydramine, were administered. On the second day, the tongue edema subsided, and the cuff leak test was negative. However, extubation was not attempted due to the development of brain edema. A tracheostomy was later performed, and the patient was weaned off mechanical ventilation.
      PubDate: 2019-10-11
      DOI: 10.1007/s40800-019-0104-9
  • Acute Kidney Injury Following Exposure to Calcineurin Inhibitors in a
           Patient with Idiopathic Membranous Nephropathy

    • Abstract: Abstract Membranous nephropathy (MN) is one of the most common causes of nephrotic syndrome in non-diabetic adult patients; 75% of adult patients with MN suffer from primary idiopathic membranous nephropathy (IMN). The treatment of choice is immunosuppressive therapy, with a combination of steroids and cyclophosphamide (CYF) or chlorambucil or, as second-line treatment, calcineurin inhibitors (CNIs). One of the main concerns associated with the usage of CNIs is their potential to induce nephrotoxicity. We report a case of acute kidney injury that developed on two separate occasions within days of the administration of CNIs in a 57-year-old male patient treated for MN. The patient was qualified for first-line treatment with prednisone and CYF. Due to insufficient response and bad tolerance of CYF infusions, the immunosuppressive regimen was modified and CNIs were introduced, starting with cyclosporine A (CsA). On the third day of treatment, a severe decrease in diuresis and kidney function occurred and CsA was discontinued, resulting in a return to baseline kidney function. After 2 months, the situation repeated after attempting to introduce tacrolimus.
      PubDate: 2019-10-05
      DOI: 10.1007/s40800-019-0103-x
  • Allopurinol-Induced Toxic Epidermal Necrolysis

    • Abstract: Abstract Toxic epidermal necrolysis (TEN) is an extremely rare condition characterized by separation of dermoepidermal junctions, necrosis, and subsequent detachment of the epidermis over large cutaneous areas. TEN can emerge after exposure to certain medications such as allopurinol, aromatic anticonvulsants, NSAIDs, nevirapine, and antibacterial sulfonamides. There is no standard protocol for TEN, and the therapy of choice varies from one patient to another. Some of these therapies include silver-releasing wraps/dressings, glucocorticoids, antibodies to inhibit Fas-mediated keratinocyte apoptosis, and cyclosporine A. A 35-year-old male with an allergy to antibacterial sulfonamides who was being treated for arterial hypertension and hyperuricemia with captopril and allopurinol, respectively, was admitted to hospital. The patient showed skin detachment affecting approximately 95% of his surface area, including his face, upper and lower extremities, trunk, back, oropharyngeal mucosa, anal mucosa, ocular mucosa, and genital mucosa. Intravenous methylprednisolone at a dosage of 40 mg/day for 7 days along with abrasive cures was found to be an appropriate treatment in this case.
      PubDate: 2019-09-23
      DOI: 10.1007/s40800-019-0101-z
  • Isoniazid-Induced Systemic Lupus Erythematosus: A Case Report

    • Abstract: Abstract Systemic lupus erythematosus (SLE) can be induced by various medications, such as hydralazine, procainamide, isoniazid, methyldopa, chlorpromazine, quinidine, and minocycline. A patient was admitted complaining of fever with chills and rigor. After being diagnosed with tuberculous meningitis, the patient was given antituberculosis treatment. As the patient did not improve, detailed investigations were conducted, and elevated antinuclear antibody levels were found. The consulting physician diagnosed that the patient was suffering from SLE. As isoniazid is associated with an increased risk of developing SLE, it was suspected as the culprit drug. After withdrawing isoniazid from the antituberculosis treatment regimen, the patient improved and was discharged. Based on the WHO-UMC and Naranjo’s causality assessment criteria, an association between the reaction and isoniazid was deemed probable. The reaction was moderately severe (level 4b) according to the modified Hartwig and Siegel scale.
      PubDate: 2019-09-20
      DOI: 10.1007/s40800-019-0102-y
  • Fatal Vitamin K-Dependent Coagulopathy Associated with
           Cefoperazone/Sulbactam: A Case Report

    • Abstract: Abstract This case report describes a suspected and fatal adverse reaction involving vitamin K-dependent coagulopathy that might be associated with cefoperazone/sulbactam (CPZ/SAM), a combined antimicrobial formulation. We reported a patient diagnosed with acute cerebral infarction and secondary pulmonary infection who was treated with an intravenous infusion of CPZ/SAM at 3 g twice daily. After receiving treatment with CPZ/SAM, the patient developed a fatal adverse reaction of CPZ-induced hemorrhage. The Naranjo assessment score in this report was 5, suggesting that the patient’s coagulation function disorder was potentially associated with the use of CPZ/SAM. To prevent vitamin K-dependent coagulopathy caused by CPZ/SAM, it is suggested to avoid cephalosporins in patients with a high risk of bleeding unless the need for cephalosporins is compelling.
      PubDate: 2019-06-14
      DOI: 10.1007/s40800-019-0100-0
  • Gastroschisis Following Treatment with High-Dose Methimazole in Pregnancy:
           A Case Report

    • Abstract: Abstract Hyperthyroidism in pregnancy is associated with a increased incidence of low birth weight, preterm birth and admission to the neonatal intensive care unit. However, available treatment options are limited. In this report, we present a case of fetal gastroschisis with a history of intrauterine exposure to methimazole. A 37-year-old woman was diagnosed with Grave’s disease 3 years before her pregnancy. She had a poor response to propylthiouracil and required high-dose methimazole before her pregnancy. During the first trimester, she received methimazole 120 mg/day. After her 12th week of pregnancy, she received block-and-replace therapy (levothyroxine [LT4] 50 µg/day) because of the risk of hypothyroidism, and the dose of methimazole was downtitrated to 60 mg/day. Fetal ultrasonography showed fetal growth retardation and gastroschisis at gestational week 33. The relationship between the very high doses of methimazole in the first trimester of pregnancy and the incidence of gastroschisis in this patient was not fully understood because evidence of a relationship between the use of antithyroid drugs in the first trimester and congenital abnormalities in the fetus is lacking. Furthermore block-and-replace therapy is not recommended in pregnancy because it requires a higher dose of methimazole. We recommend preconception counseling and early screening of thyroid function. The counseling should include the best timeline for pregnancy and a discussion of the risks and benefits of hyperthyroidism treatment options.
      PubDate: 2019-05-23
      DOI: 10.1007/s40800-019-0099-2
  • Anaphylactic Reaction to Tc-99m Macrosalb

    • Abstract: Abstract A 49-year-old woman developed an anaphylactic reaction to Tc-99m macrosalb used for pulmonary scintigraphy. The patient received an intravenous injection of Tc-99m macrosalb 120 MBq, containing macroaggregates of human albumin 0.14 mg. Within 1 min she developed itching all over her body, an itching throat and dyspnoea. This was followed by urticaria and facial oedema. She was diagnosed with an anaphylactic shock. The patient received clemastine and prednisone, and fully recovered after release from the hospital. According to the Naranjo assessment algorithm, the relationship between the allergic reaction and the administration of Tc-99m macrosalb should be considered as ‘probable’.
      PubDate: 2019-03-05
      DOI: 10.1007/s40800-019-0097-4
  • Ibrutinib Caused Mediastinal Emphysema and Pneumothorax in the Treatment
           of a Patient with Mantle Cell Lymphoma

    • Abstract: Abstract A 70-year-old Japanese man with mantle cell lymphoma underwent extensive chemotherapy and radiation because of the relapse of mantle cell lymphoma. He developed mediastinal emphysema and a pneumothorax 14 days after treatment with 560 mg of ibrutinib. The mediastinal emphysema and the right pneumothorax disappeared after the ibrutinib treatment was tapered off. The patient developed interstitial pneumonia without any infection and new lesions of mantle cell lymphoma in the lungs after restarting treatment with 560 mg of ibrutinib. In this case, the patient developed pneumonia after retreatment with ibrutinib, suggesting the small lung fibrosis that penetrated the mediastinum might have caused the emphysema and pneumothorax.
      PubDate: 2019-02-21
      DOI: 10.1007/s40800-019-0098-3
  • Acute Exacerbation of Fever Following Administration of Tropicamide and
           Phenylephrine Ophthalmic Solution: A Case Report

    • Abstract: Abstract A 24-year-old woman with atopic dermatitis and persistent fever (axillary temperature of 37–38 °C for 6 months) received combination ophthalmic drops containing tropicamide and phenylephrine (Mydrin®-P), which exacerbated her fever within 15 min after instillation. Her axillary fever reached 40.1 °C but resolved the following day. No new dermatological symptoms developed. Although the patient’s fever may have been caused by either tropicamide or phenylephrine, neither of which have been reported to induce fever in topical formulations, atopic dermatitis and tropicamide’s inhibitory effect on perspiration under hot and humid conditions may have been the more probable cause. While drug-induced fever has been reported for other ophthalmic anticholinergic agents, this is the first reported case of possible fever exacerbation by an ophthalmic formulation of tropicamide, if the causative agent is assumed to be tropicamide.
      PubDate: 2019-02-12
      DOI: 10.1007/s40800-019-0096-5
  • An Interesting Case of Carbamazepine-Induced Stevens–Johnson

    • Abstract: Abstract A 29-year-old Black female patient was admitted to a psychiatric ward with symptoms of major depressive disorder with psychosis. The patient was started on amitriptyline 50 mg/day and haloperidol 10 mg/day. On day 4 post-admission, the preferred first-line antidepressant, fluoxetine, became available and the patient was switched from amitriptyline to fluoxetine 20 mg/day. On the same day, the dose of haloperidol was reduced to 5 mg/day. Thirteen days post-initiation of these medications the patient became talkative, associated with emotional lability, an expansive mood, irritability and restlessness. The working diagnosis was changed to bipolar affective disorder in the manic phase. Fluoxetine was discontinued and carbamazepine 600 mg/day was added to the patient’s treatment regimen. Her manic symptoms started to resolve; however, 14 days post-initiation of carbamazepine, the patient had a fever; itchy, discharging eyes; respiratory distress; generalised symmetrical erythematosus rash; buccal ulceration; and conjunctival injection with difficulty opening her eyes. Carbamazepine was immediately discontinued and the patient received intravenous fluid resuscitation. The patient recovered considerably after 12 days of symptomatic and supportive management, and was transferred back to the psychiatric ward for the continuation of bipolar disorder management. Lithium therapy was instituted and the patient was subsequently discharged. Using the Algorithm of Drug causality for Epidermal Necrolysis (ALDEN) Stevens–Johnson Syndrome/toxic epidermal necrolysis (SJS/TEN) drug causality scoring system, carbamazepine and fluoxetine were evaluated as ‘very probable’ and ‘possible’ causes of SJS, respectively, in this patient. Fluoxetine-induced SJS was considered on account of previous case reports, however no evidence of causality was found in this patient. Consecutive administration with a potential increase in carbamazepine due to inhibition of cytochrome P450 (CYP) 3A4 metabolism by fluoxetine was also not ruled out. A diagnosis of carbamazepine-induced SJS was made and was considered an idiosyncratic adverse drug reaction.
      PubDate: 2018-12-10
      DOI: 10.1007/s40800-018-0095-y
  • Neutropenia and Thrombocytopenia Induced by Proton Pump Inhibitors: A Case

    • Abstract: Abstract An 85-year-old man was admitted to our hospital because of dysphagia, and was diagnosed with benign stricture of the esophagus. He was hospitalized repeatedly for balloon dilations. Pantoprazole sodium (80 mg, twice daily, intravenously) was administered each time when he was in hospital, while esomeprazole (20 mg/day, orally) was administered intermittently when he was at home. Reductions in both white blood cells and platelets were noticed about 4 months after proton pump inhibitors were introduced. Bone marrow suppression induced by proton pump inhibitors was diagnosed as proven by bone marrow biopsy. White blood cell, neutrophil, and platelet counts went back to the normal range after proton pump inhibitors were stopped. The present case shows a rare bi-cytopenia associated with proton pump inhibitors and suggests the importance of awareness of hematological adverse events during proton pump inhibitor therapy.
      PubDate: 2018-11-23
      DOI: 10.1007/s40800-018-0093-0
  • Acknowledgement to Referees

    • PubDate: 2018-11-22
      DOI: 10.1007/s40800-018-0094-z
  • Curling of Hair in Two Female Patients Taking Alitretinoin

    • Abstract: Abstract Two female patients aged 45 and 51 years experienced curling of hair during treatment with alitretinoin (Toctino®). For one patient, the indication for use was severe chronic hand eczema, but for the second patient the indication was not reported. After 5 and 9 months, respectively, the patients developed hair texture changes and their straight hair began to curl. The dose of alitretinoin was reduced in both cases, but the patients’ hair had not straightened at the time of reporting (9 months and 2 years after onset of the event). Based on the described reports received by the Netherlands Pharmacovigilance Centre Lareb, the case reports in the literature, and the possible mechanisms, we suggest a causal relationship between curling of the hair and the use of alitretinoin. Using the World Health Organization Uppsala Monitoring Centre (WHO-UMC) system for standardized case causality assessment, the association in our cases can be assessed as likely.
      PubDate: 2018-10-16
      DOI: 10.1007/s40800-018-0092-1
  • Acute Myocardial Infarction Following Administration of Polyethylene
           Glycol Electrolyte Solution with Ascorbic Acid (MoviPrep ® ) at Home: A
           Case Report

    • Abstract: Abstract A male individual aged 82 years with hypertension who had a smoking history, but no history of cardiovascular events, developed acute myocardial infarction immediately after he took oral polyethylene glycol electrolyte solution with ascorbic acid as a pretreatment for a colonoscopy to examine anemia. He took polyethylene glycol electrolyte solution with ascorbic acid at twice (2 L/h) the rate recommended in the package insert and by the physician. The patient showed impaired consciousness 2 h after taking polyethylene glycol electrolyte solution with ascorbic acid and his family called the emergency medical service. Upon arrival of the emergency medical service, his systolic blood pressure was 60 mmHg and heart rate was 50 bpm. Systolic blood pressure and impaired consciousness were slightly improved, but compensatory shock remained, at arrival at the emergency outpatient service at our hospital. No dyspnea or rash was apparent. The patient had no subjective chest pain; however, ST-segment elevation was detected in the electrocardiogram at II, III, aVF, V3R, and V4R. He was diagnosed with ST-segment elevation myocardial infarction and underwent a coronary catheter intervention for total occlusion of the right coronary artery. His shock state was abolished by this intervention. The patient was pretreated with polyethylene glycol electrolyte solution with ascorbic acid under close watch in the coronary care unit 4 days later, with no relapse of symptoms. Advanced cancer was found in the ileocecum by colonoscopy; consequently, the patient underwent a colectomy and was discharged from our hospital and transferred to another hospital for rehabilitation on hospital day 74. A Naranjo assessment score of 4 was obtained, indicating a possible relationship of acute myocardial infarction with misuse of the suspect drug, polyethylene glycol electrolyte solution with ascorbic acid.
      PubDate: 2018-08-27
      DOI: 10.1007/s40800-018-0091-2
  • Metoclopramide: A Safe Alternative to Domperidone' A Case Report on
           Severe Cardiac Adverse Effects in an Older Patient

    • Abstract: Abstract Peripheral antidopaminergic medication is frequently prescribed to treat nausea. However, domperidone is ill-famed for its severe cardiac adverse effects. Metoclopramide has been suggested as a relatively safe alternative because it has long been considered to have less significant cardiovascular adverse effects. We present an older patient who developed severe bradycardia and hypotension shortly after receiving intravenous metoclopramide. Cardiac adverse effects of metoclopramide in elderly are not frequently described in the literature, especially not in patients without a major history of cardiac disease. We recommend caution with intravenous administered metoclopramide in older patients.
      PubDate: 2018-08-07
      DOI: 10.1007/s40800-018-0090-3
  • Antituberculosis Drug-Induced Fixed Drug Eruption: A Case Report

    • Abstract: Abstract Fixed drug eruption (FDE) was caused by fixed-dose combination (FDC) of antituberculosis drugs in the form of tablet Forecox® (rifampicin [rifampin] 225 mg + isoniazid 150 mg + pyrazinamide 750 mg + ethambutol 400 mg) in a 40-year-old male patient with a history of drug allergy. The patient developed FDE after taking the third dose of tablet Forecox® for pulmonary tuberculosis. Tablet Forecox® was withdrawn and the patient recovered from the reaction after 15 days of treatment for FDE. As per World Health Organization–Uppsala Monitoring Centre (WHO-UMC) and Naranjo causality assessment criteria, the association between the reaction and tablet Forecox® was possible and probable, respectively. The reaction was moderately (Level 4b) severe according to the Modified Hartwig and Siegel scale. As there is an increased risk of allergic reaction in patients with a history of drug allergy, FDCs should not be used in order to avoid complexity in identifying the culprit drug.
      PubDate: 2018-05-21
      DOI: 10.1007/s40800-018-0086-z
  • Secondary Hypogammaglobulinemia After Rituximab for Neuromyelitis Optica:
           A Case Report

    • Abstract: Abstract A 17-year-old male with history of neuromyelitis optica and seizures presented to the pulmonology clinic for evaluation of recurrent pneumonias. He had received rituximab for the past 6 years. Over the past 2 years, he experienced four episodes of pneumonia. In between these episodes, he would improve briefly but continued to have daily cough that was productive with yellow phlegm. He also had recurrent rhinitis and sinusitis despite multiple antibiotic courses. Review of chest X-rays revealed localized right middle lobe and right lower lobe infiltrates. An extensive workup was performed, including computed tomography (CT) of the chest and bronchoscopy to rule out congenital lesions of the right lung and foreign body aspiration. Chest CT showed right lower lobe bronchiectasis. Flexible bronchoscopy with bronchoalveolar lavage showed normal anatomy with thick mucus secretions in the right lower lobe. Immunologic evaluation was performed and revealed low levels of immunoglobulin (Ig)-G, IgM, and IgA, which had declined since initiation of rituximab. Lymphocyte subset testing was remarkable for low cluster of differentiation (CD)-19. He was referred to allergy and immunology and was initiated on immunoglobulin-replacement therapy (IGRT) for acquired hypogammaglobulinemia secondary to rituximab. There was marked clinical improvement after initiation of IGRT.
      PubDate: 2018-05-11
      DOI: 10.1007/s40800-018-0087-y
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