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Life-Threatening Drug-Induced Rashes

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102. Bosulif (bosutinib (as monohydrate))

authorisation The CHMP considered that bosutinib falls within the scope of Regulation (EC) No 507/2006: Article 2(1) – medicinal product which aims at the treatment, the prevention or the medical diagnosis of seriously debilitating diseases or life-threatening diseases. Article 2(3) – medicinal product designated as orphan medicinal product in accordance with Article 3 of Regulation (EC) No 141/2000. In accordance with Article 3 (2) of Regulation EC No 507/2006, the CHMP proposed the application (...) or inhibition of the serotonin transporters may lead to increased gastric secretion or nausea, respectively, at clinically relevant concentrations of bosutinib. The potential for agonist activity at the neurokinin A receptor leading to a proinflammatory response is of low probability. While rash was observed in some patients, an inflammatory response was not observed in animal studies at concentrations exceeding those in humans. Bosutinib M5 (N-desmethyl bosutinib) and M2 (oxydechlorinated bosutinib

2013 European Medicines Agency - EPARs

103. Tybost - cobicistat

the Committee, issued a positive opinion for granting a Marketing Authorisation to Tybost. Assessment report Page 8/86 2. Scientific discussion 2.1. Introduction Problem statement There are approximately 33 million people worldwide living with HIV-1. HIV-1 infection remains is a life-threatening disease in infected persons who do not receive adequate treatment sufficiently early in the course of the infection and/or are infected with virus that is resistant to anti-retroviral agents of several classes

2013 European Medicines Agency - EPARs

104. Stivarga - regorafenib

Cochran-Mantel-Haenszel CRC colorectal cancer CYP cytochrome P450 DCE-MRI Dynamic contrast enhanced MRI (magnetic resonance imaging) DILI drug-induced liver injury DPD dihydro-pyrimidine dehydrogenase ECG electrocardiogram ECOG Eastern Cooperative Oncology Group EGFR epidermal growth factor receptor FACS fluorescence activated cell sorter FOLFIRI folinic acid (leucovorin), 5-fluorouracil, irinotecan FOLFOX folinic acid (leucovorin), 5-fluorouracil, oxaliplatin GGT gamma glutamyl transferase HB

2013 European Medicines Agency - EPARs

105. Kadcyla - trastuzumab emtansine

infiltration during administration (see SmPC section 4.8). If the prior infusion was well tolerated, subsequent doses of trastuzumab emtansine may be administered as 30 minute infusions. Patients should be observed during the infusion and for at least 30 minutes after infusion. The infusion rate of trastuzumab emtansine should be slowed or interrupted if the patient develops infusion-related symptoms (see SmPC sections 4.4 and 4.8). Trastuzumab emtansine should be discontinued in case of life-threatening

2013 European Medicines Agency - EPARs

106. Otrexup (methotrexate) auto-injector

Recommendation on Regulatory Action Based on the data submitted by the applicant, this reviewer recommends the complete response for this NDA. Because of the considerable risk associated with treatment with methotrexate, the clinical benefit for patients with moderate to severe psoriasis is different from the one for patients with “severe, recalcitrant, disabling psoriasis unresponsive to other forms of therapy”. Moderate to severe psoriasis is not a life threatening disorder and the vast majority (...) infections, are life threatening and result in death and hospitalizations. Because of this considerable risk, methotrexate’s use is limited to patients with most severe disease that is also non-responsive to other forms of therapy. It is reasonable to conclude that because methotrexate is effective in treating severe psoriasis, it would also be effective in treating patients with milder disease. In addition, it is expected that the safety profile in the population of patients with milder psoriasis would

2013 FDA - Drug Approval Package

107. Tasimelteon (Hetlioz)

gastroenteritis, no treatment-emergent serious adverse event was experienced by more than one subject. The proportion of subjects who experienced any treatment-emergent adverse event that led to early termination was fairly even between treatment groups in the entire safety database. Treatment-emergent adverse events which led to early discontinuations in two or more subjects in the tasimelteon group were: nightmare (n = 3), rash (n = 3), insomnia/middle insomnia (n = 3) and blood CK increased (n = 2

2013 FDA - Drug Approval Package

110. Irritable bowel syndrome

of . The impact of symptoms on daily functioning such as home, work, school, and leisure activities. Any clinical features suggesting an , including a serious or life-threatening condition, and arrange admission or referral if appropriate. See the CKS topic on for more information on red flag indicators. The person's diet (including fibre intake), nutrition, and any known food triggers (such as alcohol, caffeine, spicy and fatty foods) — consider the use of a food diary to determine an association between (...) symptoms are often affected by psychological stress or the person's emotional response to stress [ ]. Differential diagnosis What else might it be? Alternative conditions which may present similarly to irritable bowel syndrome include: Malignancy (such as colorectal cancer, small bowel cancer, and lymphoma) — see the CKS topic on for more information. Other causes of constipation, such as: Functional or drug-induced constipation — see the CKS topic on for more information. Hypothyroidism — see the CKS

2017 NICE Clinical Knowledge Summaries

111. Alogliptin and alogliptin/pioglitazone

Congestive heart failure CI Confidence interval Cmax Maximum concentration CMC Chemistry Manufacturing and Controls CR Complete response Cr Creatinine CrCl Creatinine clearance CRF Case report form CV Cardiovascular DBP Diastolic blood pressure DDI Drug-drug interaction DILI Drug-induced liver injury DMC Data monitoring committee DMEP Division of Metabolism and Endocrinology Products DMEPA Division of Medication Error Prevention and Analysis DMF Drug master file DMPP Division of Medical Policy Programs (...) , the PSURs, and an enhanced pharmacovigilance PMR. • Skin lesions: The percentage of subjects reporting PCDR events was higher in the alogliptin 25 mg and all alogliptin groups when compared to all comparators (6.9% and 7.4% versus 5.7%). (The list of preferred terms comprising PCDRs was agreed upon with the sponsor prior to resubmission.) The most common events were rash and prurititis. Although these skin reactions are not likely related to the necrotic lesions seen with other DPP4 inhibitors

2012 FDA - Drug Approval Package

113. Teriflunomide

: 3185084 23 Hypersensitivity There were no life-threatening events that could reasonably be considered related to hypersensitivity. However, the following adverse reactions were reported more frequently on drug than on placebo in Pool 1: Event Placebo Ter 7 Ter 14 Rash 4% 5% 6% Pruritis 2% 4% 3% Erythema 0.5% 2% 1% Urticaria 0.5% 1% 1% Two cases of erythema nodosum and one case of erythema multiforme were reported in patients on teriflunomide (both doses) but these resolved with continued treatment (...) mg; N=1, 14 mg). Common Adverse Events The following chart displays the most common adverse events seen in Pool 1, for which the incidence is greater on drug than placebo: Event Placebo Ter 7 Ter 14 N=421 N=429 N=415 % % % Diarrhea 8 14 17 Alopecia 4 11 15 Nausea 7 9 14 ALT increased 7 13 14 Influenza 9 10 12 Paraesthesia 8 10 11 Rash 4 5 6 Laboratory findings Reference ID: 3185084 18 The following chart displays the mean changes in important laboratory analytes in Pool 1: Mean change from

2012 FDA - Drug Approval Package

114. Dabigatran for Stroke Prevention in Atrial Fibrillation: A Review of the Evidence on Safety

related to dabigatran treatment revealed 508 ADR reports, of which 500 (89%) were considered serious. Of the serious ADR reports, 62 were associated with death and 14 with disability; 54 were considered life-threatening, and 297 occurred in association with hospitalizations. Of the 508 ADR reports filed, 192 were associated with the 150- mg dosing and 179 with the 110- mg dosing. Reported exposures ranged from 2 to 186 days. Mean reported age was 74.8 years (median= 78.0 years). More reports detailed (...) . Whitehead H, Boyd JM, Blais DM, Hummel J. Drug-induced exanthem following dabigatran. Ann Pharmacother. 2011 Oct;45(10):e53. 23. Hanf W, Duntze J, Hida H, Blanc Q, Reynaud C. [The implication of a direct antithrombine in the appearance of (serious) postoperative acute respiratory distress]. Ann Fr Anesth Reanim. 2009 Oct;28(10):885-8. French. 24. Kulik A, Saltzman MB, Morris JJ. Dabigatran after cardiac surgery: caution advised. J Thorac Cardiovasc Surg. 2011 Nov;142(5):1288. Dabigatran in Atrial

2012 Canadian Agency for Drugs and Technologies in Health - Rapid Review

115. Evidence-based guidelines for treating bipolar disorder

a lifetime perspective. Anxiety symptoms are often persistent between episodes and may contribute to mood insta- bility (I). Anxiety disorders are associated with increased illness burden and poor outcome (I): they require assessment and treatment (S). Stimulant drugs may mimic manic symptoms (II). A drug- induced state, including psychosis, should wane with the clear- ance of the offending drug (II): use 5 half-lives as the relevant interval (and the longest half-life stated in a range). Levodopa

2016 British Association for Psychopharmacology

116. Ankle edema after administration of selective serotonin reuptake inhibitors Full Text available with Trip Pro

Ankle edema after administration of selective serotonin reuptake inhibitors Clinical manifestations of drug-induced skin reactions include a wide range of symptoms, from mild drug-induced exanthemas to dangerous and life-threatening generalized systematic reactions. Drug-induced skin reactions to psychotropic medication are usually associated with antiepileptic drugs. However, a significant role can be assigned to selective serotonin reuptake inhibitors. We report a case of a female patient

2018 Mental illness

117. Severe cutaneous adverse reactions induced by targeted anticancer therapies and immunotherapies Full Text available with Trip Pro

Severe cutaneous adverse reactions induced by targeted anticancer therapies and immunotherapies With the increasing use of targeted anticancer drugs and immunotherapies, there have been a substantial number of reports concerning life-threatening severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms, drug-induced hypersensitivity syndrome, and acute generalized exanthematous (...) discuss the clinical course, latency, concomitant medication, tolerability of rechallenge or alternatives, tumor response, and mortality associated with these devastating conditions. Imatinib, vemurafenib, and rituximab were the top three offending medications that most commonly caused SJS/TEN, while EGFR inhibitors were the group of drugs that most frequently induced SJS/TEN. For drug rash with eosinophilia and systemic symptoms/drug-induced hypersensitivity syndrome and acute generalized

2018 Cancer management and research

118. Anaphylactic reactions due to pantoprazole: case report of two cases Full Text available with Trip Pro

40 mg tablet. A 32-year-old female reported to the emergency ward in a critical condition, with complaints of rashes all over the body, itching on the whole body, and swollen lips and eyes after ingestion of a pantoprazole 40 mg tablet.It is necessary for all health care providers to know that pantoprazole can cause anaphylaxis, which is a life-threatening reaction, and to be cautious while prescribing it. (...) Anaphylactic reactions due to pantoprazole: case report of two cases Drug-induced hypersensitivity reaction is of great clinical significance in therapeutics. The objective of this reporting of two cases is to show that anaphylaxis reaction can occur with pantoprazole.A 38-year-old female reported to the emergency ward in a critical condition, with a history of periorbital edema, edema of the skin, pruritus, nausea, vomiting, and difficulty breathing 20 minutes after ingestion of a pantoprazole

2018 International medical case reports journal

119. A Study of ASP1948, Targeting an Immune Modulatory Receptor, in Subjects With Advanced Solid Tumors

of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization (except if prolongation of planned hospitalization is not caused by an AE). Hospitalization for treatment/observation/examination caused (...) (indicating acute Hepatitis B virus (HBV) or chronic HBV) or Hepatitis C (HCV ribonucleic acid (RNA) (qualitative); subject with negative Hepatitis C antibody testing may not need RNA testing. Subject has received a live vaccine against infectious diseases within 28 days prior to initiation of study treatment. Subject has a history of drug-induced pneumonitis (interstitial lung disease) or currently has pneumonitis. Subject has an active infection requiring systemic therapy (e.g., intravenous antibiotics

2018 Clinical Trials

120. Vancomycin-Induced Stevens-Johnson Syndrome in a Boy Under 2 Years Old: An Early Diagnosis by Granulysin Rapid Test Full Text available with Trip Pro

Vancomycin-Induced Stevens-Johnson Syndrome in a Boy Under 2 Years Old: An Early Diagnosis by Granulysin Rapid Test Stevens-Johnson syndrome (SJS) is a life-threatening disease, which is mainly ascribed to drugs, such as sulfonamides and psychoepileptics. In this article, we present a pediatric case of vancomycin-induced SJS and an alternative diagnostic algorithm. The patient presented with multiple target-like rashes and vesicles throughout the whole body after receiving vancomycin. Despite (...) the fact that skin biopsy remains the gold standard for diagnosing SJS, the granulysin rapid test by immunochromatographic assay is a non-invasive option for children. In this article, we describe our use of the Algorithm of Drug causality for Epidermal Necrolysis and a modified T-cell activation assay for granzyme B and interferon gamma to screen for the culprit drug. Moreover, we applied the granulysin rapid test as an early diagnosis method for children with drug-induced SJS.

2018 Frontiers in pediatrics

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