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{ "abstract": "Here, we describe a 79-year-old man, admitted to our unit for worsening diplopia and fatigue, started a few weeks after an episode of bronchitis and flu vaccination. Past medical history includes myasthenia gravis (MG), well-controlled by Pyridostigmine, Azathioprine, and Prednisone. During the first d...
[ { "companynumb": "IT-NVP-000027", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugadditional": "3", "drugadmi...
{ "abstract": "Severe acute respiratory syndrome coronavirus 2 disease is strongly associated with a high incidence of thrombotic events. Anticoagulation could be a cornerstone in successfully managing severe forms of coronavirus disease 2019 (COVID-19). However, optimal anticoagulant dosing in elderly patients is ch...
[ { "companynumb": "FR-TEVA-2021-FR-1935821", "fulfillexpeditecriteria": "1", "occurcountry": "FR", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "AZITHROMYCIN ANHYDROUS" }, "drugadditional": "1...
{ "abstract": "Despite some clinician advocacy for the use of gabapentin to treat neonatal irritability of presumed neurological origin, the extent of gabapentin administration to hospitalized neonates is unknown. We aimed to identify trends in gabapentin utilization among infants hospitalized in neonatal intensive c...
[ { "companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2019-07558", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "LISINOPRIL" }, "druga...
{ "abstract": "Paronychia has been described as a side effect in patients undergoing treatment with MEK (mitogen activated protein kinase enzyme) inhibitors. It is usually a recurrent condition that can have a significant impact in the quality of life. Topical beta blocker treatment has been described as an effective...
[ { "companynumb": "NVSC2019ES041059", "fulfillexpeditecriteria": "1", "occurcountry": "ES", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "TIMOLOL" }, "drugadditional": "3", "drugadmi...
{ "abstract": "Plasma cell differentiation (PCD) is frequently observed in some entities of non-Hodgkin B cell lymphoma, including both low-grade and high-grade lymphomas. However, except for plasmablastic lymphoma and primary effusion lymphoma, EBV+ B cell lymphoproliferative disorder (LPD) with PCD has not been wel...
[ { "companynumb": "NVSC2020JP302246", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "METHOTREXATE" }, "drugadditional": "1", "dru...
{ "abstract": "Psoriasis is a common, disfiguring and stigmatizing skin disease associated with impaired quality of life. In patients with severe psoriasis unresponsive to other treatments, cyclosporine can induce a rapid remission. Although drug-induced gingival overgrowth (GO) is a frequent side effect, in the guid...
[ { "companynumb": "PHHY2017IT017679", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "CYCLOSPORINE" }, "drugadditional": "3", "dru...
{ "abstract": "A common cause of subcutaneous mycoses in immunocompetent patients is traumatic inoculation. This is the first reported case of cutaneous infection with Petriella setifera in a human host. A 49-year-old immunocompetent man sustained a splinter from his wooden deck, which resulted in a chronic cutaneous...
[ { "companynumb": "US-SLATE RUN PHARMACEUTICALS-21US000474", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "VORICONAZOLE" }, "drugadditiona...
{ "abstract": "Linear IgA bullous dermatosis (LAD) is an autoimmune, chronic bullous disease affecting primarily young children and adults. Studies on LAD are relatively sparse and from Scandinavia we could only find a few case reports. Therefore we decided to conduct a retrospective investigation of patients seen at...
[ { "companynumb": "PHHY2015DK041023", "fulfillexpeditecriteria": "1", "occurcountry": "DK", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "PENICILLIN G BENZATHINE" }, "drugadditional": null, ...
{ "abstract": "The treatment of endometrial cancer (EC) is challenging. There is no standard of care for patients who progressed after carboplatin and paclitaxel (CT) and all available drugs show a small response and poor long-term survival in this scenario. The objective of this study was to evaluate the efficacy an...
[ { "companynumb": "BR-CIPLA (EU) LIMITED-2018BR07623", "fulfillexpeditecriteria": "1", "occurcountry": "BR", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugadditional": "3"...
{ "abstract": "Ototoxicity associated with narcotic-acetaminophen combinations is not widely recognized. This can be the cause of severe-to-profound hearing loss that may be overlooked. Otolaryngologists who encounter patients with progressive hearing loss with no apparent cause should specifically ask about overuse ...
[ { "companynumb": "CA-CIPLA LTD.-2017CA04993", "fulfillexpeditecriteria": "1", "occurcountry": "CA", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "AMITRIPTYLINE" }, "drugadditional": "3", ...
{ "abstract": "BACKGROUND\nNon-Hodgkin lymphomas are a heterogeneous group, which involve either B or T lymphocytes. The most used treatment is a chemotherapy regimen, which includes cyclophosphamide, hydroxydaunorubicin, oncovin and prednisone combined with rituximab - a monoclonal antibody specific for CD20 - an an...
[ { "companynumb": "IT-FRESENIUS KABI-FK201601646", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "DOXORUBICIN" }, "drugadditional": null, ...
{ "abstract": "OBJECTIVE\nThionamides (methimazole and propylthiouracil) have been associated with common side effects, such as rash and pruritus, and rare but serious adverse effects, such as agranulocytosis and hepatotoxicity. Methimazole is usually the preferred thionamide for the treatment of hyperthyroidism if t...
[ { "companynumb": "US-PFIZER INC-202200732404", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "METHIMAZOLE" }, "drugadditional": null, ...
{ "abstract": "Pisa syndrome (or pleurothotonus), consisting of a tonic flexion of the trunk, has been recently reported also in association with atypical antipsychotics. We describe the first case of Pisa syndrome during aripiprazole treatment in an elderly (77-year-old) woman, admitted to hospital for behavioural a...
[ { "companynumb": "NVSC2020IT092886", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "ASPIRIN" }, "drugadditional": "3", "drugadmi...
{ "abstract": "We present a 78-year-old male with renal cell carcinoma who developed myasthenia gravis complicated by myositis after nivolumab administration, which was verified by the presence of antibodies against the acetylcholine receptor. The initial symptom was posterior neck pain, and biochemical examination o...
[ { "companynumb": "JP-BRISTOL-MYERS SQUIBB COMPANY-BMS-2020-006453", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "NIVOLUMAB" }, "drugaddi...
{ "abstract": "We herein describe the case of a 68-year-old man who developed overt diabetes mellitus following the topical administration of dexamethasone 0.1%-containing ointment over a five-month period to treat oral lichen planus. The topical dexamethasone therapy was discontinued gradually, and the patient was s...
[ { "companynumb": "JP-BAUSCH-BL-2015-019125", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "drugadditional": null, ...
{ "abstract": "A 48-year-old man had convulsions, and magnetic resonance angiography (MRA) showed diffuse constriction of the cerebral arteries. He was suspected of having primary angiitis of the central nervous system (PACNS) and treated with steroid for three days. The MRA abnormality disappeared after a week. Afte...
[ { "companynumb": "JP-AMGEN-JPNSP2021127690", "fulfillexpeditecriteria": "2", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "4", "activesubstance": { "activesubstancename": "APREMILAST" }, "drugadditional": null, ...
{ "abstract": "Primary CNS lymphoma (PCNSL) harbors mutations that reinforce B cell receptor (BCR) signaling. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, targets BCR signaling and is particularly active in lymphomas with mutations altering the BCR subunit CD79B and MYD88. We performed a proof-of-concept ph...
[ { "companynumb": "US-JNJFOC-20170625463", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "CYTARABINE" }, "drugadditional": null, ...
{ "abstract": "The combination of ombitasvir, dasabuvir, and paritaprevir/ritonavir (considered as the 3D regimen) has proven to be associated with high sustained virologic response and optimal tolerability in hepatitis C virus-infected patients. Here, we describe an HIV-HCV-coinfected patient who experienced a grade...
[ { "companynumb": "IT-ABBVIE-16P-083-1647538-00", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "RIBAVIRIN" }, "drugadditional": "1", ...
{ "abstract": "Erdheim-Chester disease (ECD) is a rare non-Langerhans histiocytic disorder. We report a 76-years-old man who suffered a cardiac tamponade secondary to ECD. A pericardial window was made and during the operation the surgeons observed that the myocardium was diffusely infiltrated. Twenty-eight months be...
[ { "companynumb": "CL-PFIZER INC-2016227506", "fulfillexpeditecriteria": "1", "occurcountry": "CL", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugadditional": null, ...
{ "abstract": "The hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (hyper-CVAD) regimen has been widely used for lymphoblastic lymphoma (LBL) as a primary treatment. However, there is few data about its treatment outcome in Asian patients. Thus, we conducted this study to evaluate the ...
[ { "companynumb": "KR-BAXTER-2015BAX040028", "fulfillexpeditecriteria": "1", "occurcountry": "KR", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugadditional": null, ...
{ "abstract": "Folate supplementation in women of reproductive age has a well-established role in the prevention of neural tube defects. Methotrexate is a commonly used drug which functions by inhibiting normal folate metabolism in active cells. An association between fetal methotrexate exposure and myelomeningocele ...
[ { "companynumb": "US-ZYDUS-013518", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "METHOTREXATE" }, "drugadditional": null, "dru...
{ "abstract": "BACKGROUND\nThe administration of carboplatin AUC 7 has become a standard adjuvant option for patients undergoing orchiectomy for stage I seminoma, in alternative to radiotherapy on retroperitoneal lymphnodes or surveillance. The toxicity of AUC 7 carboplatin appeared manageable in the pivotal trial of...
[ { "companynumb": "IT-PFIZER INC-2016263422", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugadditional": null, ...
{ "abstract": "Data concerning the use of leflunomide-a drug approved for rheumatoid arthritis with in vitro anticytomegalovirus (CMV) activity-in lung transplant (LT) recipients are scarce.\n\n\n\nTo report the use of leflunomide in LT recipients diagnosed with CMV infection/disease.\n\n\n\nWe performed a single-cen...
[ { "companynumb": "ES-EXELA PHARMA SCIENCES, LLC-2018EXL00007", "fulfillexpeditecriteria": "1", "occurcountry": "ES", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "LEFLUNOMIDE" }, "drugadditi...
{ "abstract": "BACKGROUND\nExtrapulmonary tuberculosis (EPTB) is associated with high rates of morbidity and mortality. Diagnosis of EPTB is challenging in resource-limited settings due to difficulties in obtaining samples, as well as the paucibacillarity of the specimens. Skeletal tuberculosis accounts for 10-35 % o...
[ { "companynumb": "TZ-SA-2016SA185331", "fulfillexpeditecriteria": "1", "occurcountry": "TZ", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "ISONIAZID" }, "drugadditional": "3", "drug...
{ "abstract": "We report a patient who developed drug-eluting stent (DES) thrombosis induced by discontinuation of dual antiplatelet therapy (DAPT) and subsequently had a massive surgical site bleed caused by restarting heparin and DAPT during the perioperative period. An 85-year-old man visited a local hospital owin...
[ { "companynumb": "PHHY2016JP010843", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "ASPIRIN" }, "drugadditional": null, "drugad...
{ "abstract": "Invasive fungal infections are a major complication and an important cause of morbidity and mortality among solid organ transplant recipients. Their diagnosis is difficult and their prognosis is often pejorative.\n\n\nOBJECTIVE\nThe aim of this study was to report the cases of invasive fungal infection...
[ { "companynumb": "TN-PFIZER INC-2015095584", "fulfillexpeditecriteria": "1", "occurcountry": "TN", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugadditional": null, ...
{ "abstract": "BACKGROUND\nClinical trials have shown the efficacy of omalizumabs efficacy in refractory chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), but real-life management strategies are lacking.\n\n\nOBJECTIVE\nTo assess the long-term efficacy and safety of omalizumab, and to ident...
[ { "companynumb": "PT-ROCHE-1958869", "fulfillexpeditecriteria": "1", "occurcountry": "PT", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "OMALIZUMAB" }, "drugadditional": "3", "druga...
{ "abstract": "BACKGROUND\nPrimary essential cutis verticis gyrata is a condition that usually affects healthy subjects associated to convoluted folds and furrows formed from thickened skin of the scalp resembling cerebriform pattern.\n\n\nMETHODS\nwe describe a case of association between primary essential cutis ver...
[ { "companynumb": "IT-MYLANLABS-2019M1091963", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "INDOMETHACIN" }, "drugadditional": null, ...
{ "abstract": "Hemophagocytic Lymphohistiocytosis (HLH) is a hyperinflammatory disorder that may be encountered as a primary or secondary phenomenon. HLH secondary to lymphoma has been described, more frequently in adults than in children. T-cell/Histiocyte-rich B-cell lymphoma (THRLBCL) is a large B-cell lymphoma th...
[ { "companynumb": "US-APOTEX-2018AP008682", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "ETOPOSIDE" }, "drugadditional": null, ...
{ "abstract": "Ipilimumab is used for the treatment of metastatic melanoma and is associated with serious immune-related colitis. We aimed to report the clinical features, treatment, and outcomes of patients with ipilimumab-induced colitis. In this retrospective observational study, we identified patients with unrese...
[ { "companynumb": "US-JNJFOC-20140514152", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "BUDESONIDE" }, "drugadditional": null, ...
{ "abstract": "We present a case which reports the occurrence of psychotic disorders after metronidazole and levofloxacin therapy in a chronic kidney patient while being treated for enterocolitis and urinary infection. A 48-year-old female was admitted to a hospital for the placement of a peritoneal dialysis catheter...
[ { "companynumb": "RS-UNICHEM PHARMACEUTICALS (USA) INC-UCM201810-000278", "fulfillexpeditecriteria": "1", "occurcountry": "RS", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "LEVOFLOXACIN" }, ...
{ "abstract": "A 63-year old, male patient presented with prosthetic valve endocarditis and developed heparin-induced thrombocytopaenia (HIT) following heparin administration for continuous veno-venous haemofiltration. Use of cardiopulmonary bypass in patients suffering from heparin-induced thrombocytopaenia is diffi...
[ { "companynumb": "PHHY2015GB011234", "fulfillexpeditecriteria": "1", "occurcountry": "GB", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "HEPARIN SODIUM" }, "drugadditional": null, ...
{ "abstract": "Neonatal thrombosis is considered a rare manifestation with unclear aetiology. We reported a neonatal lupus of a Sjogren's syndrome mother with recurrent miscarriage secondary to antiphospholipid syndrome; seronegative to anticardiolipin antibodies, lupus anticoagulant and B2GP1. She was serologically ...
[ { "companynumb": "PHHY2019EG160311", "fulfillexpeditecriteria": "1", "occurcountry": "EG", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "LEVOTHYROXINE" }, "drugadditional": null, "d...
{ "abstract": "BACKGROUND\nHACEK (Haemophilus spp., Aggregatibacter spp., Cardiobacterium spp., Eikenella corrodens, and Kingella spp.) group organisms are responsible for 0.8% to 6% of all infective endocarditis cases, with Cardiobacterium spp. being the third most commonly implicated HACEK microorganism. Within thi...
[ { "companynumb": "US-BAYER-2021-126052", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "ATORVASTATIN" }, "drugadditional": null, ...
{ "abstract": "OBJECTIVE\nAlthough most patients with low-grade glioma (LGG) present after a seizure, a small proportion is diagnosed after neuroimaging is performed for a sign or symptom unrelated to the tumor. While these tumors invariably grow, some surgeons argue for a watchful waiting approach. Here, the authors...
[ { "companynumb": "US-AUROBINDO-AUR-APL-2021-049775", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "LEVETIRACETAM" }, "drugadditional": "3...
{ "abstract": "While antipsychotic medications have long been associated with anticholinergic effects, asenapine has been purported to have no capacity for muscarinic cholinergic antagonism based on in vitro studies. Research in rat brain tissue has yielded different results, with one study finding more cholinergic M...
[ { "companynumb": "CA-TEVA-2022-CA-2001139", "fulfillexpeditecriteria": "1", "occurcountry": "CA", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "ARIPIPRAZOLE" }, "drugadditional": "1", ...
{ "abstract": "Drug reaction with eosinophilia with systemic symptoms (DRESS) syndrome is a rare drug reaction often presenting with both cutaneous manifestations and potentially life-threatening internal organ involvement. The precise incidence of DRESS is still unclear as it is easily missed due to its highly varia...
[ { "companynumb": "US-SCIEGENP-2021SCLIT00990", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "LAMOTRIGINE" }, "drugadditional": "1", ...
{ "abstract": "BACKGROUND\nLung cancer is one of the most common malignancies worldwide. Non-small cell lung cancer (NSCLC) comprises the majority of the cases of lung cancer. Previous studies have demonstrated a role for both the estrogen pathway and mammalian target of rapamycin (mTOR) in NSCLC.\n\n\nMETHODS\nThis ...
[ { "companynumb": "AU-MYLANLABS-2016M1036437", "fulfillexpeditecriteria": "1", "occurcountry": "AU", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "EVEROLIMUS" }, "drugadditional": "1", ...
{ "abstract": "Extremely low birth weight infants (birth weight ≤1000 g) have a significantly lower nephron number. The glomerular filtration rate (GFR) is usually sufficient under normal conditions but is unable to meet the needs during stress, which results in acute kidney injury (AKI). We describe the case of an e...
[ { "companynumb": "SI-BAUSCH-BL-2021-037846", "fulfillexpeditecriteria": "1", "occurcountry": "SI", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "GENTAMICIN" }, "drugadditional": "1", ...
{ "abstract": "Tumor necrosis factor (TNF)-targeted therapies are increasingly used to treat a variety of inflammatory and autoimmune diseases. They are now used worldwide, and this class of medication has revolutionized the treatment of these diseases and the quality of life for patients but it also poses risk of de...
[ { "companynumb": "FR-JNJFOC-20150701772", "fulfillexpeditecriteria": "1", "occurcountry": "FR", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "INFLIXIMAB" }, "drugadditional": null, ...
{ "abstract": "Cancer immunotherapy has been used in several malignancies with clinical benefit. Despite the clinical success, immune-related adverse events are frequent and endocrinopathies can be particularly severe. We report a 55-year-old male patient with stage IV pulmonary carcinoma treated with nivolumab who p...
[ { "companynumb": "PT-TEVA-2019-PT-1118455", "fulfillexpeditecriteria": "1", "occurcountry": "PT", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "ESCITALOPRAM OXALATE" }, "drugadditional": "1",...
{ "abstract": "West Nile virus (WNV) is an emerging human pathogen responsible for a systemic disease with generally indolent clinical course in immunocompetent hosts. Solid organ transplant recipients are vulnerable to WNV-induced encephalitis (WNVE) with no effective treatment and high mortality. We systematically ...
[ { "companynumb": "US-TEVA-2021-US-1882853", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugadditional": "3", ...
{ "abstract": "BACKGROUND\nNumb chin syndrome is caused by a mental or inferior alveolar nerve neuropathy. Traumatic and infectious injuries are the most frequent causes of the syndrome but, if an evident cause does not exist, a neoplastic etiology must be investigated. Other causes of the numb chin syndrome are rare...
[ { "companynumb": "ES-FRESENIUS KABI-FK202008492", "fulfillexpeditecriteria": "1", "occurcountry": "ES", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "ZOLEDRONIC ACID" }, "drugadditional": "1"...
{ "abstract": "This is a case of systemic ropivacaine toxicity from a sciatic nerve catheter. A 20-year-old patient after heart transplant with poor systemic perfusion on hemodialysis and multiple medications experienced local anesthetic systemic toxicity 72 hours after placement of a peripheral nerve catheter. The c...
[ { "companynumb": "US-MYLANLABS-2015M1021654", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "VORICONAZOLE" }, "drugadditional": null, ...
{ "abstract": "BACKGROUND\nAntituberculosis (anti-TB) drug allergy often involves multiple concurrently administered drugs which subsequently need to be reinitiated as no better alternatives exist.\n\n\nOBJECTIVE\nTo describe the results of tailored sequential desensitization-rechallenge (D-R) for anti-TB drug allerg...
[ { "companynumb": "SG-SA-2014SA116678", "fulfillexpeditecriteria": "1", "occurcountry": "SG", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "ISONIAZID" }, "drugadditional": null, "dru...
{ "abstract": "Macrophage activation syndrome, a severe complication of systemic juvenile idiopathic arthritis and other inflammatory diseases, represents one of the most important rheumatological emergencies. Delayed diagnosis could lead to life-threatening complications. Pulmonary hemosiderosis has been classically...
[ { "companynumb": "TR-BIOVITRUM-2015TR0583", "fulfillexpeditecriteria": "1", "occurcountry": "TR", "patient": { "drug": [ { "actiondrug": "4", "activesubstance": { "activesubstancename": "ANAKINRA" }, "drugadditional": null, ...
{ "abstract": "Spontaneous heparin-induced thrombocytopenia (HIT) is a rare but serious prothrombotic syndrome characterized by thrombosis, thrombocytopenia, and strong platelet-activating HIT antibodies in the absence of heparin exposure, and is frequently characterized by a suboptimal response to standard therapies...
[ { "companynumb": "US-SAKK-2018SA397298AA", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "HEPARIN SODIUM" }, "drugadditional": "1", ...
{ "abstract": "Rhabdomyolysis is a rare and complex condition that involves injury of the skeletal muscle fibres, resulting in the release of substances such as creatine kinase and myoglobin. It is associated with acute kidney injury and mortality. This article describes the case of a 40-year-old man who presented to...
[ { "companynumb": "GB-AMNEAL PHARMACEUTICALS-2020-AMRX-01137", "fulfillexpeditecriteria": "1", "occurcountry": "GB", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "TRAMADOL HYDROCHLORIDE" }, "d...
{ "abstract": "Recent retrospective analyses and phase II trials have shown differential outcomes in adolescents and young adults when treated with pediatric compared with adult protocols. The aim of this study was to evaluate the efficacy and toxicity of the Dana Farber Consortium Protocol (DFCP) in Saudi young adul...
[ { "companynumb": "SA-PFIZER INC-2018027052", "fulfillexpeditecriteria": "1", "occurcountry": "SA", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "DOXORUBICIN HYDROCHLORIDE" }, "drugadditional"...
{ "abstract": "Medication errors remain among the major problems seen in hospitals. Such errors can relate to the prescription, dispensation, or administration of drugs. Human factors account for most of these mistakes, but other factors such as infusion pump programming defects should always be considered. Worldwide...
[ { "companynumb": "JO-FRESENIUS KABI-FK201804762", "fulfillexpeditecriteria": "1", "occurcountry": "JO", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "AMINO ACIDS" }, "drugadditional": null, ...
{ "abstract": "Bupropion is a frequently used medication. Excessive doses may cause altered mental status, seizures, and dysrhythmias. There is a need for accurate estimate of seizure risk with therapeutic errors and determination if minor symptoms are harbingers of more severe effects.\nA retrospective review of adu...
[ { "companynumb": "US-MYLANLABS-2022M1041069", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "BUPROPION" }, "drugadditional": "4", ...
{ "abstract": "The authors present the youngest reported case of a single oral overdose of methotrexate in an otherwise well 19-month-old child who was treated with delayed folinic acid rescue. Initial history revealed possible ingestion of up to 10 tablets, each containing 2.5 mg of methotrexate. The peak methotrexa...
[ { "companynumb": "GB-PFIZER INC-2011111723", "fulfillexpeditecriteria": "1", "occurcountry": "GB", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "METHOTREXATE SODIUM" }, "drugadditional": null...
{ "abstract": "Purpose: To report the cytopathology of vitreous biopsy samples in patients with acute retinal necrosis (ARN) who underwent pars plana vitrectomy (PPV). We also describe two patients with unique clinical courses, cytopathologic findings, and immune responseMethods: A retrospective review of patients wi...
[ { "companynumb": "US-CHEPLA-2021000527", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "GANCICLOVIR" }, "drugadditional": null, ...
{ "abstract": "Rhabdomyolysis is a syndrome with a wide range of symptoms ranging from asymptomatic raised serum creatinine kinase to life-threatening metabolic disturbances and acute kidney injury. A careful history taking and high clinical suspicion on drug-drug interaction are crucial to identify the etiology of r...
[ { "companynumb": "MY-TEVA-2021-MY-1919882", "fulfillexpeditecriteria": "1", "occurcountry": "MY", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "TELMISARTAN" }, "drugadditional": "3", ...
{ "abstract": "Adult-onset Still's disease (AOSD) is an uncommon inflammatory condition characterised by a triad of fevers, arthralgias and a salmon-coloured rash. It is also strongly associated with high ferritin levels, whose role in its pathogenesis is not entirely clear. Central nervous system (CNS) manifestation...
[ { "companynumb": "US-UCBSA-2020047923", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "LEVETIRACETAM" }, "drugadditional": "4", ...
{ "abstract": "Immune checkpoint inhibitors (ICI) are increasingly being used to treat numerous cancer types. Together with improved recognition of toxicities, this has led to more frequent identification of rare immune-related adverse events (irAE), for which specific treatment strategies are needed. Neutropenia is ...
[ { "companynumb": "DE-MENARINI-DE-MEN-080521", "fulfillexpeditecriteria": "1", "occurcountry": "DE", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "PEMBROLIZUMAB" }, "drugadditional": "1", ...
{ "abstract": "A 34-year-old man presented to a community hospital with fever and fatigue for 3 days and was found to be febrile and tachycardic with a cavitary pulmonary lesion and paratracheal adenopathy on CT imaging. One month before, he had presented to his primary care provider with a palmar rash; he had been d...
[ { "companynumb": "US-STRIDES ARCOLAB LIMITED-2022SP000750", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "TENOFOVIR DISOPROXIL FUMARATE" }, ...
{ "abstract": "It is common practice in many centers to offer antithrombotic medications to women with unexplained recurrent miscarriage, in the presence or absence of inherited thrombophilia. Although no benefit of aspirin vs placebo has been clearly demonstrated, a double-blind placebo-controlled trial on the effec...
[ { "companynumb": "FR-SA-2015SA053489", "fulfillexpeditecriteria": "1", "occurcountry": "FR", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "ENOXAPARIN SODIUM" }, "drugadditional": null, ...
{ "abstract": "In 2009 we reported the fatal case of a toddler who had received codeine after adenotonsillectomy for obstructive sleep apnea syndrome. The child was an ultra-rapid metabolizer of cytochrome P4502D6 (CYP2D6). We now report 3 additional fatal or life-threatening cases from North America. In the 2 fatal ...
[ { "companynumb": "CA-INGENUS PHARMACEUTICALS NJ, LLC-ING201611-000112", "fulfillexpeditecriteria": "1", "occurcountry": "CA", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "...
{ "abstract": "Axicabtagene ciloleucel is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy. In the previous analysis of the ZUMA-1 registrational study, with a median follow-up of 15·4 months (IQR 13·7-17·3), 89 (82%) of 108 assessable patients with refractory large B-cell lymphoma treated with ...
[ { "companynumb": "US-PFIZER INC-2018516709", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugadditional": null, ...
{ "abstract": "We report a case of a 75-year-old female post orthotopic heart transplantation, who presented to the emergency department with a six-week history of shortness of breath, hand tremor and ultimately delirium. She had lobular breast carcinoma more than 5 years prior to her heart transplant, treated by lum...
[ { "companynumb": "NVSC2020CA242492", "fulfillexpeditecriteria": "1", "occurcountry": "CA", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "MYCOPHENOLATE MOFETIL" }, "drugadditional": "3", ...
{ "abstract": "BACKGROUND\nUncontrolled intracranial hypertension can lead to cerebral herniation and death in patients with acute liver failure.\n\n\nMETHODS\nA 26-year-old female was admitted for acute liver failure following inadvertent acetaminophen overdose. The pH on admission was 6.9. Her neurologic status pre...
[ { "companynumb": "GR-VISTAPHARM, INC.-VER202107-001593", "fulfillexpeditecriteria": "1", "occurcountry": "GR", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "ACETAMINOPHEN\\HYDROCODONE" }, "dr...
{ "abstract": "Leflunomide has recently been introduced for systemic treatment of rheumatoid arthritis. It has both immunosuppressive effects and anti-inflammatory properties. We report a patient treated with leflunomide who developed vasculitis as an adverse side effect. As far as we are aware, this is the first pub...
[ { "companynumb": "DK-SA-2020SA209259", "fulfillexpeditecriteria": "1", "occurcountry": "DK", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "LEFLUNOMIDE" }, "drugadditional": "1", "dr...
{ "abstract": "A 57-year-old woman with no noteworthy medical or surgical history underwent an interscalene block with bupivacaine in preparation for an arthroscopic rotator cuff repair. Following administration of the bupivacaine, the patient sustained a ventricular fibrillation arrest. After successful cardiopulmon...
[ { "companynumb": "US-FRESENIUS KABI-FK201804655", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "BUPIVACAINE" }, "drugadditional": null, ...
{ "abstract": "Since its market release, gabapentin has been presumed to have no abuse potential and subsequently has been prescribed widely off-label, despite increasing reports of gabapentin misuse. This review estimates and describes the prevalence and effects of, motivations behind and risk factors for gabapentin...
[ { "companynumb": "US-ALKEM LABORATORIES LIMITED-US-ALKEM-2018-07227", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "GABAPENTIN" }, "druga...
{ "abstract": "Acanthamoeba is a protozoa that can lead to severe ocular disease and sequelae. Although intraocular Acanthamoeba infection is rare, the following case demonstrates an unusual presentation of recurrent Acanthamoeba infection in a 30 year old contact lens wearing male.\nAfter presenting with recurrent A...
[ { "companynumb": "US-BAUSCH-BL-2018-036269", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "TRIFLURIDINE" }, "drugadditional": null, ...
{ "abstract": "We report a case of an anticoagulated patient with sudden onset pleural hematoma after straining at defecation to cardiac arrest on 2 weeks after lobectomy for lung cancer. We decided to perform an emergent operation for an evacuation of extrapleural hematoma immediately after resuscitation. The bleedi...
[ { "companynumb": "JP-Indoco-000271", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "APIXABAN" }, "drugadditional": "3", "drugadm...
{ "abstract": "The combination of exemestane and everolimus is a new treatment option for metastatic hormone-sensitive breast cancer. This treatment is used after progression on non-steroidal aromatase inhibitors. The treatment is generally well tolerated, but sometimes leads to minor or even serious side effects. It...
[ { "companynumb": "NL-PFIZER INC-2014232958", "fulfillexpeditecriteria": "1", "occurcountry": "NL", "patient": { "drug": [ { "actiondrug": "4", "activesubstance": { "activesubstancename": "EXEMESTANE" }, "drugadditional": null, ...
{ "abstract": "BACKGROUND\nWhile double primary cancers are common in breast cancer patients, co-existence of primary gastric cancer and gastric metastases of breast cancer is exceedingly rare.\n\n\nMETHODS\nA 51-year-old woman receiving chemotherapy for breast cancer presented with melena and presyncope. A circumfer...
[ { "companynumb": "JP-DSJP-DSJ-2021-138495", "fulfillexpeditecriteria": "2", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "DENOSUMAB" }, "drugadditional": "4", ...
{ "abstract": "OBJECTIVE\nTo report a case of delayed-onset bilateral scleral thinning and calcium deposition following a cosmetic ocular-whitening procedure (I-BRITE(®)).\n\n\nMETHODS\nA 33-year-old male patient with a history of right-sided ptosis repair and left-sided anterior uveitis had previously undergone bila...
[ { "companynumb": "US-ACCORD-029802", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "MITOMYCIN" }, "drugadditional": null, "druga...
{ "abstract": "The HIV-associated renal diseases represent a spectrum. Indian data on this is sparse. This study was undertaken to find out the prevalence and clinicopathological spectrum of renal involvement in HIV among antiretroviral therapy (ART) naïve patients (Group 1) and among those on ART (Group 2).\n\n\n\nS...
[ { "companynumb": "IN-GILEAD-2018-0351818", "fulfillexpeditecriteria": "1", "occurcountry": "IN", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "TENOFOVIR DISOPROXIL FUMARATE" }, "drugadditiona...
{ "abstract": "•Metastatic invasive ductal carcinoma.•IDC metastasis to cervix.•Unusual metastasis to cervix.", "affiliations": "Stony Brook University Hospital, United States.;Stony Brook University Hospital, United States.;Stony Brook University Hospital, United States.;Stony Brook University Hospital, United Sta...
[ { "companynumb": "US-TOLMAR, INC.-20US023233", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "LEUPROLIDE ACETATE" }, "drugadditional": "3"...
{ "abstract": "We aimed to evaluate the safety and effectiveness of 12 or 24 weeks treatment with ledipasvir and sofosbuvir, with or without ribavirin, in treatment-experienced patients with hepatitis C virus (HCV) genotype 1 infection and cirrhosis in routine clinical practice. Patients were followed in a multi-cent...
[ { "companynumb": "US-KADMON PHARMACEUTICALS, LLC-KAD201806-000359", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "RIBAVIRIN" }, "drugaddi...
{ "abstract": "Caffeine has long been recognized as an addictive substance that causes autonomic nerve effect, and is known to increase catecholamine secretion from the adrenal glands. In recent years, the risk of ingesting toxic levels of caffeine has increased because of the easy availability of analgesics, CNS (Ce...
[ { "companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2016R1-125214", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "CAFFEINE" }, "drugad...
{ "abstract": "Only a few earlier clinical radiologic reports exist describing post-COVID-19 pulmonary fibrosis. We report a case of 74-year-old woman referred with dizziness and hypoxemic respiratory failure with chest high resolution computer tomography (HRCT) showing ground glass opacities and emphysema. The patie...
[ { "companynumb": "IT-PFIZER INC-2021373552", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "AZITHROMYCIN ANHYDROUS" }, "drugadditional": "...
{ "abstract": "Numerous medications have been associated to the development of priapism as an adverse reaction, the most common are intracavernosal vasoactive agents, antipsychotics and antidepressants. Alpha blockers, in particular tamsulosin which is widely used in different urological conditions, has been associat...
[ { "companynumb": "TR-ALKEM LABORATORIES LIMITED-TR-ALKEM-2019-08837", "fulfillexpeditecriteria": "1", "occurcountry": "TR", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "TAMSULOSIN HYDROCHLORIDE" }, ...
{ "abstract": "Background: Metformin is a biguanide antihyperglycemic agent that decreases insulin resistance. It is removed through renal mechanisms and its clearance is reduced in renal failure. Metformin ingestion should always be considered in the differential diagnosis of any patient with metabolic acidosis and ...
[ { "companynumb": "IT-LUPIN PHARMACEUTICALS INC.-2015-02062", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "GLICLAZIDE" }, "drugadditiona...
{ "abstract": "BACKGROUND\nBone marrow transplantation (BMT) for class 3 patients with thalassemia is challenging due to high rates of graft rejection and transplant-related mortality. Since the first studies of BMT in the late 1980s, a number of conditioning regimens have been designed to improve outcomes, but with ...
[ { "companynumb": "IT-SA-2015SA173337", "fulfillexpeditecriteria": "1", "occurcountry": "IT", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "AZATHIOPRINE" }, "drugadditional": null, "...
{ "abstract": "OBJECTIVE\nThere still remain many concerns about the present status of antiviral therapy for chronic hepatitis B in developing countries in Asia, where the monitoring systems of virological markers have not been well established, despite the high prevalence of hepatitis B virus (HBV) infection. To inv...
[ { "companynumb": "JP-CIPLA (EU) LIMITED-2018NP16212", "fulfillexpeditecriteria": "1", "occurcountry": "NP", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "LAMIVUDINE" }, "drugadditional": null...
{ "abstract": "Sodium valproate is a broad spectrum anti-seizure medication useful in the treatment of both generalized and focal epilepsies. The association between valproate and female reproductive disorders is well understood and delineated. Male infertility however is an under-recognised adverse effect of Valproa...
[ { "companynumb": "IE-ACI HEALTHCARE LIMITED-2112785", "fulfillexpeditecriteria": "1", "occurcountry": "IE", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "VALPROIC ACID" }, "drugadditional": n...
{ "abstract": "BACKGROUND\nNasal-type extranodal natural killer (NK)/T-cell lymphomas are a rare type of clinical condition. Reconstruction of the complex nasal defect after chemoradiation is extremely challenging for plastic surgeons.\n\n\nMETHODS\nHere we present the case of a 56-year old female with the condition ...
[ { "companynumb": "VN-BAXTER-2019BAX009888", "fulfillexpeditecriteria": "1", "occurcountry": "VN", "patient": { "drug": [ { "actiondrug": "6", "activesubstance": { "activesubstancename": "ETOPOSIDE" }, "drugadditional": null, ...
{ "abstract": "Anticoagulation for cardiopulmonary bypass (CPB) is required to prevent acute disseminated intravascular coagulation and clot formation within the bypass circuit. Unfractionated heparin is the standard anticoagulant for CPB due to its many advantages and long history of successful use. However, heparin...
[ { "companynumb": "US-TEVA-2019-US-1061372", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "WARFARIN" }, "drugadditional": "3", "...
{ "abstract": "Nitrous oxide is increasingly being used as a recreational drug. Prolonged use of nitrous oxide can have disabling neurological sequelae due to functional inactivation of vitamin B₁₂. We present three cases illustrating the neurological complications of using nitrous oxide. Two of these patients receiv...
[ { "companynumb": "GB-LINDE-GB-LHC-2019036", "fulfillexpeditecriteria": "1", "occurcountry": "GB", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "NITROUS OXIDE" }, "drugadditional": "1", ...
{ "abstract": "OBJECTIVE\nHydroxychloroquine (HCQ) has a low risk of retinal toxicity which increases dramatically with a cumulative dose of >1000 g. Here we report a case of HCQ macular toxicity presentation in a young patient with a cumulative dose of 438 g.\n\n\nMETHODS\nA 15-year-old female started attending annu...
[ { "companynumb": "CH-CONCORDIA PHARMACEUTICALS INC.-CO-PL-CH-2016-035", "fulfillexpeditecriteria": "1", "occurcountry": "CH", "patient": { "drug": [ { "actiondrug": null, "activesubstance": { "activesubstancename": "CHOLECALCIFEROL" }, ...
{ "abstract": "Hemophilia A, also known as factor VIII deficiency, is a rare disorder caused by an insufficient level of factor VIII, an essential clotting protein. Hemophilia A can be inherited or acquired. Inherited hemophilia A is caused by a mutation to the factor VIII gene on the X chromosome, which is commonly ...
[ { "companynumb": "US-TEVA-2020-US-1812649", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "ANTIHEMOPHILIC FACTOR, HUMAN RECOMBINANT" }, "d...
{ "abstract": "Critically ill patients are at risk of developing both acute kidney injury (AKI) and invasive fungal infections (IFIs). Prompt and efficient treatment of the IFI is essential for the survival of the patient. This article examines three distinct clinical situations where liposomal amphotericin B, a broa...
[ { "companynumb": "GB-ASTELLAS-2020US019691", "fulfillexpeditecriteria": "1", "occurcountry": "GB", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugadditional": "3", ...
{ "abstract": "BACKGROUND\nRegorafenib is a multiple tyrosine kinase inhibitor, and the use of this drug is approved for the treatment of cancers that are resistant to chemotherapy, which include advanced colorectal cancer, gastrointestinal stromal tumor, and hepatocellular carcinoma. However, the drug causes adverse...
[ { "companynumb": "JP-BAYER-2019-236225", "fulfillexpeditecriteria": "2", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "REGORAFENIB" }, "drugadditional": null, ...
{ "abstract": "Uterine leiomyosarcoma is a rare type of malignant gynecological tumor and has a poor prognosis; therefore, this tumor is often difficult to treat. Some new drugs have been approved during the past several years in Japan and are expected to be efficacious. Eribulin, one of these drugs, is a natural pro...
[ { "companynumb": "PHHY2019JP022132", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "TRABECTEDIN" }, "drugadditional": "3", "drug...
{ "abstract": "A case of methemoglobinemia secondary to topical local anesthetic agents is reported. A 28-year-old, 80-kg white man was admitted to a hospital for respiratory distress two days after an accident. During intubation, Cetacaine (benzocaine, butamben, and tetracaine) spray and Americaine (benzocaine) oint...
[ { "companynumb": "US-SA-2018SA260196", "fulfillexpeditecriteria": "1", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "LIDOCAINE" }, "drugadditional": "3", "drug...
{ "abstract": "We present a multimodal method combining quantitative electroencephalography (EEG), behavior and pharmacology for pre-clinical screening of analgesic efficacy in vivo. The method consists of an objective and non-invasive approach for realtime assessment of spontaneous nociceptive states based on EEG re...
[ { "companynumb": "JP-ALKEM LABORATORIES LIMITED-JP-ALKEM-2018-09844", "fulfillexpeditecriteria": "2", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "MINOCYCLINE\\MINOCYCLINE HYDROCHLORIDE" ...
{ "abstract": "Previous studies have suggested that tacrolimus (TAC) is more potent than cyclosporine (CSA) for prophylaxis against acute GVHD after allogeneic hematopoietic stem cell transplantation (HSCT). However, the target blood concentrations of these drugs in these studies were not consistent with the current ...
[ { "companynumb": "JP-ASTELLAS-2015JP020359", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "METHOTREXATE" }, "drugadditional": null, ...
{ "abstract": "The efficacy of inhaled antibiotics to treat chronic Pseudomonas aeruginosa pulmonary infection in patients with cystic fibrosis (CF) has been well established. Few data are available on the value of continuous alternating inhaled antibiotic therapy (CAIT), a strategy increasingly used in the managemen...
[ { "companynumb": "BE-MYLANLABS-2018M1010520", "fulfillexpeditecriteria": "1", "occurcountry": "BE", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "TOBRAMYCIN" }, "drugadditional": null, ...
{ "abstract": "Background Precision medicine and drug repurposing are attractive strategies, especially for tumors with worse prognosis. Glioblastoma is a highly malignant brain tumor with limited treatment options and short survival times. We identified novel BRAF (47-438del) and PIK3R1 (G376R) mutations in a gliobl...
[ { "companynumb": "PHHY2017DE057802", "fulfillexpeditecriteria": "1", "occurcountry": "DE", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "ONDANSETRON" }, "drugadditional": "3", "drug...
{ "abstract": "An all-case, single-arm, observational, postmarketing surveillance is underway to assess the safety of tafamidis in patients with hereditary transthyretin (ATTRv) amyloidosis with peripheral polyneuropathy, also called transthyretin-type familial amyloid polyneuropathy, in Japan. Results from an interi...
[ { "companynumb": "JP-PFIZER INC-2017128051", "fulfillexpeditecriteria": "1", "occurcountry": "JP", "patient": { "drug": [ { "actiondrug": "4", "activesubstance": { "activesubstancename": "TAFAMIDIS MEGLUMINE" }, "drugadditional": null...
{ "abstract": "To estimate the risk of hypertensive pregnancy complications in women with epilepsy, with and without antiepileptic drugs, and assess the risk associated with the four most common antiepileptic drugs.\n\n\n\nA population-based cohort study using linked data from the Medical Birth Registry of Norway and...
[ { "companynumb": "PHHY2018NO052661", "fulfillexpeditecriteria": "1", "occurcountry": "NO", "patient": { "drug": [ { "actiondrug": "5", "activesubstance": { "activesubstancename": "LEVETIRACETAM" }, "drugadditional": "3", "dr...
{ "abstract": "Topiramate is an antiepileptic drug that can also be used for migraine prophylaxis, weight control, and even for methamphetamine dependence; the dosage margin is wide, and the list of side effects is shorter than with other anticonvulsants. We present the case of a 35-year-old man with a disseminated r...
[ { "companynumb": "MX-GLENMARK PHARMACEUTICALS-2017GMK028344", "fulfillexpeditecriteria": "1", "occurcountry": "MX", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "TOPIRAMATE" }, "drugadditiona...
{ "abstract": "The increasing number of pregnant breast cancer patients calls for a therapy that is as efficient as possible. After 10 years of collecting data on pregnant breast cancer patients in the German Breast Group (GBG), proposals for diagnostic measures and therapy regarding this special situation have been ...
[ { "companynumb": "DE-ROCHE-1749477", "fulfillexpeditecriteria": "1", "occurcountry": "DE", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "TRASTUZUMAB" }, "drugadditional": "1", "drug...
{ "abstract": "The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch...
[ { "companynumb": "US-APOTEX-2016AP010458", "fulfillexpeditecriteria": "2", "occurcountry": "US", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "PAROXETINE HYDROCHLORIDE" }, "drugadditional": "...
{ "abstract": "Real-life data showed an increased incidence of bacterial infections in patients with advanced liver disease receiving a protease inhibitor (PI)-containing antiviral regimen against hepatitis C (HCV). However, the causes of this event are unknown. We hypothesized that PIs might impair innate immune res...
[ { "companynumb": "ES-JNJFOC-20161219413", "fulfillexpeditecriteria": "1", "occurcountry": "ES", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "TELAPREVIR" }, "drugadditional": null, ...
{ "abstract": "We studied the clinical features of 85 cases of phenytoin toxicity in 76 patients treated at a general hospital. Serum levels of phenytoin on admission ranged from 30.3 to 95.0 micrograms/mL (median, 46.5). Iatrogenic causes of intoxication were common and included increased daily dosage and intravenou...
[ { "companynumb": "ES-VISTAPHARM, INC.-VER202103-000960", "fulfillexpeditecriteria": "1", "occurcountry": "ES", "patient": { "drug": [ { "actiondrug": "1", "activesubstance": { "activesubstancename": "PHENYTOIN" }, "drugadditional": "1...