scholarly journals Severe haematuria of lower urinary tract origin with low dose dabigatran use in three Indian elderly patients: unresolved issues in the safety of novel oral anticoagulants

2017 ◽  
Vol 9 (1) ◽  
pp. 89-91 ◽  
Author(s):  
Upinder Kaur ◽  
Sankha Shubhra Chakrabarti ◽  
Sukdev Manna ◽  
Indrajeet Singh Gambhir
Keyword(s):  
Oral Anticoagulants ◽  
The Elderly ◽  
The United States ◽  
Novel Oral Anticoagulants ◽  
Thrombin Inhibitor ◽  
European Medicines Agency ◽  
Oral Direct Thrombin Inhibitor ◽  
United States Food ◽  
States Food ◽  
Lower Urinary

Dabigatran is a newer oral direct thrombin inhibitor approved by the United States Food and Drug Administration and the European Medicines Agency (EMA). The proper dosage of the drug, the potential for adverse drug reactions and the nature of bleeds with use of this drug as with other novel oral anticoagulants (NOACs), in the elderly population are still areas of uncertainty. Despite the existence of a specific antibody, idarucizumab which is an antidote to dabigatran toxicity, management of dabigatran-induced bleeds is an undefined area especially in resource constrained settings. We report severe haematuria with dabigatran in three elderly Indian patients at the lowest recommended therapeutic dose and explore these grey zones in dabigatran therapy.

Potassium binders

ESC CardioMed ◽  
2018 ◽  
pp. 218-221
Author(s):  
Keld P. Kjeldsen ◽  
Juan Tamargo ◽  
Thomas A. Schmidt
Keyword(s):  
United States ◽  
Clinical Pharmacology ◽  
Gastrointestinal Tract ◽  
The United States ◽  
European Medicines Agency ◽  
Sodium Polystyrene Sulfonate ◽  
United States Food ◽  
States Food ◽  
Potassium Binders ◽  
Sodium Zirconium Cyclosilicate

Potassium binders are used for the treatment of and prophylaxis against hyperkalaemia. Already in 1958, the United States Food and Drug Administration (FDA) approved sodium polystyrene sulfonate, a potassium binder exchanging sodium for potassium in the gastrointestinal tract. In 2015, the FDA approved a new potassium binder, patiromer sorbitex calcium (Veltassa®), exchanging calcium for potassium, and in 2017, it was approved by the European Medicines Agency (EMA). Furthermore, in 2018, the FDA and the EMA approved another new potassium binder, sodium zirconium cyclosilicate (Lokelma®), exchanging sodium for potassium. The clinical pharmacology aspects of potassium binders are reviewed in this chapter.

Potassium binders

ESC CardioMed ◽  
2018 ◽  
pp. 218-221
Author(s):  
Keld P. Kjeldsen ◽  
Juan Tamargo ◽  
Thomas A. Schmidt
Keyword(s):  
United States ◽  
Clinical Pharmacology ◽  
Gastrointestinal Tract ◽  
The United States ◽  
European Medicines Agency ◽  
Sodium Polystyrene Sulfonate ◽  
United States Food ◽  
States Food ◽  
Potassium Binders ◽  
Sodium Zirconium Cyclosilicate

Potassium binders are used for the treatment of and prophylaxis against hyperkalaemia. Already in 1958, the United States Food and Drug Administration (FDA) approved sodium polystyrene sulfonate, a potassium binder exchanging sodium for potassium in the gastrointestinal tract. In 2015, the FDA approved a new potassium binder, patiromer sorbitex calcium (Veltassa®), exchanging calcium for potassium, and in 2017, it was approved by the European Medicines Agency (EMA). Furthermore, in January 2018 approval by the FDA of another new potassium binder, sodium zirconium cyclosilicate (ZS-9®), exchanging sodium for potassium, is pending. The clinical pharmacology aspects of potassium binders are reviewed in this chapter.

Nephrogenic systemic fibrosis

2013 ◽  
pp. 1001-1006
Author(s):  
Cate H. Orteu
Keyword(s):  
United States ◽  
Renal Failure ◽  
Contrast Agents ◽  
Drug Administration ◽  
Nephrogenic Systemic Fibrosis ◽  
Food And Drug Administration ◽  
The United States ◽  
European Medicines Agency ◽  
United States Food ◽  
States Food

Nephrogenic systemic fibrosis (NSF) is a severe and disabling fibrosing condition of the skin and systemic organs. It occurs in patients with renal failure who have been exposed to gadolinum-based contrast agents (GBCAs). The development of NSF should be preventable if adequate precautions are taken in relation to GBCA exposure in susceptible patients. New cases should be reported to the European Medicines Agency and/or the United States Food and Drug Administration.

scholarly journals Strategies to prevent anthracycline-induced cardiotoxicity in cancer survivors

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Neha Bansal ◽  
M. Jacob Adams ◽  
Sarju Ganatra ◽  
Steven D. Colan ◽  
Sanjeev Aggarwal ◽  
...  
Keyword(s):  
The Elderly ◽  
Cancer Diagnostics ◽  
European Medicines Agency ◽  
Cardiovascular Comorbidities ◽  
Thoracic Radiation ◽  
United States Food ◽  
Short And Long Term ◽  
States Food ◽  
Anthracycline Chemotherapy

AbstractCancer diagnostics and therapies have improved steadily over the last few decades, markedly increasing life expectancy for patients at all ages. However, conventional and newer anti-neoplastic therapies can cause short- and long-term cardiotoxicity. The clinical implications of this cardiotoxicity become more important with the increasing use of cardiotoxic drugs. The implications are especially serious among patients predisposed to adverse cardiac effects, such as youth, the elderly, those with cardiovascular comorbidities, and those receiving additional chemotherapies or thoracic radiation. However, the optimal strategy for preventing and managing chemotherapy-induced cardiotoxicity remains unknown. The routine use of neurohormonal antagonists for cardioprotection is not currently justified, given the marginal benefits and associated adverse events, particularly with long-term use. The only United States Food and Drug Administration and European Medicines Agency approved treatment for preventing anthracycline-related cardiomyopathy is dexrazoxane. We advocate administering dexrazoxane during cancer treatment to limit the cardiotoxic effects of anthracycline chemotherapy.

scholarly journals Review of Treatment Options for Myelofibrosis: Focus on Ruxolitinib

2013 ◽  
Vol 5 ◽  
pp. CMT.S9566
Author(s):  
Donal P. McLornan ◽  
John Laurie ◽  
Claire N. Harrison
Keyword(s):  
Treatment Options ◽  
Clinical Trial Data ◽  
Primary Myelofibrosis ◽  
The United States ◽  
Janus Kinase ◽  
European Medicines Agency ◽  
Polycythaemia Vera ◽  
Jak2 Inhibitor ◽  
United States Food ◽  
States Food

In November 2011, the United States Food and Drug Administration (FDA) approved the use of a novel Janus Kinase (JAK) 1/JAK2 inhibitor, INCB 018424 (ruxolitinib), for use in both intermediate and high risk myelofibrosis. Approvals of this agent in both Canada and Europe have followed most recently. The European Medicines Agency (EMA) concluded that ruxolitinib was indicated for disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis, post-polycythaemia vera (PV) myelofibrosis, and post-essential thrombocythaemia (ET) myelofibrosis. In this review we will consider the rationale for targeting of the JAK-pathway, discuss the pharmacological profile of ruxolitinib and review the currently available clinical trial data. We will also postulate on the current and potential future roles of ruxolitinib within the MPN field.

Delirium Secondary to Lamotrigine Toxicity

2020 ◽  
Vol 15 (2) ◽  
pp. 156-159 ◽  
Author(s):  
Deborah L. Sanchez ◽  
Adam J. Fusick ◽  
Steven R. Gunther ◽  
Michael J. Hernandez ◽  
Gregory A. Sullivan ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Valproic Acid ◽  
Mental Status ◽  
The United States ◽  
Clinical Correlation ◽  
Medication Regimen ◽  
Medication Effects ◽  
United States Food ◽  
States Food ◽  
Rule Out

Background: Lamotrigine is a phenyltriazine medication that has been approved by the United States Food and Drug Administration as monotherapy and as an adjunctive agent for the treatment of seizure disorder. It was later approved by the FDA for the treatment of bipolar disorder. Lamotrigine is generally well tolerated by patients, but some serious symptoms can occur during treatment. These severe side effects include rashes and multi-organ failure. Lamotrigine has also been associated with the development of mental status changes, frequently when used concurrently with other medications that may impact the metabolism of lamotrigine. Objective: To present the case of a 65-year-old man being treated with lamotrigine and valproic acid who developed mental status changes after the addition of sertraline to his medication regimen, and to compare this case to existing cases reported in the literature. Discussion: Our case adds to the existing literature by demonstrating that patients may experience adverse medication effects despite lamotrigine levels that are normally considered to be in the therapeutic range, highlighting the importance of clinical correlation when obtaining medication levels. Conclusion: Clinicians should use caution interpreting lamotrigine levels when working up delirium, as normal levels may not rule out the development of lamotrigine toxicity.

scholarly journals D-Penicillamine: The State of the Art in Humans and in Dogs from a Pharmacological and Regulatory Perspective

Antibiotics ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 648
Author(s):  
Michela Pugliese ◽  
Vito Biondi ◽  
Enrico Gugliandolo ◽  
Patrizia Licata ◽  
Alessio Filippo Peritore ◽  
...  
Keyword(s):  
Veterinary Medicine ◽  
State Of The Art ◽  
European Medicines Agency ◽  
Therapeutic Goals ◽  
First Choice ◽  
Regulatory Perspective ◽  
The World ◽  
United States Food ◽  
States Food ◽  
Food And Drugs Administration

Chelant agents are the mainstay of treatment in copper-associated hepatitis in humans, where D-penicillamine is the chelant agent of first choice. In veterinary medicine, the use of D-penicillamine has increased with the recent recognition of copper-associated hepatopathies that occur in several breeds of dogs. Although the different regulatory authorities in the world (United States Food and Drugs Administration—U.S. FDA, European Medicines Agency—EMEA, etc.) do not approve D-penicillamine for use in dogs, it has been used to treat copper-associated hepatitis in dogs since the 1970s, and is prescribed legally by veterinarians as an extra-label drug to treat this disease and alleviate suffering. The present study aims to: (a) address the pharmacological features; (b) outline the clinical scenario underlying the increased interest in D-penicillamine by overviewing the evolution of its main therapeutic goals in humans and dogs; and finally, (c) provide a discussion on its use and prescription in veterinary medicine from a regulatory perspective.

scholarly journals The Efficacy of Convalescent Plasma Use in Critically Ill COVID-19 Patients

Medicina ◽  
2021 ◽  
Vol 57 (3) ◽  
pp. 257
Author(s):  
Livius Tirnea ◽  
Felix Bratosin ◽  
Iulia Vidican ◽  
Bianca Cerbu ◽  
Mirela Turaiche ◽  
...  
Keyword(s):  
Pilot Study ◽  
Critically Ill ◽  
Critically Ill Patients ◽  
Therapeutic Option ◽  
White Blood Cells ◽  
The United States ◽  
Plasma Therapy ◽  
Reactive Protein ◽  
United States Food ◽  
States Food

Background and Objectives: On 24 March 2020, the United States Food and Drug Administration (FDA) announced the approval of convalescent plasma therapy for critically ill patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as an emergency investigational new drug. This pilot study from Romania aimed to determine if convalescent plasma transfusion can be beneficial in the treatment of selected critically ill patients diagnosed with a SARS-CoV-2 infection. Materials and Methods: Donor and receiver eligibility for critically ill coronavirus disease 2019 (COVID-19) patients was based on Romanian guidelines issued at the time of the study. Here, we describe the evolution of a total of five eligible patients diagnosed with COVID-19 who received convalescent plasma (CP) in Romania. Results: In spite of our efforts and convalescent plasma administration, three of the five patients did not survive, while the other two recovered completely. Over the course of our five-day laboratory record, the surviving patients had significantly lower values for C-reactive protein, interleukin-6, and white blood cells. Conclusions: This pilot study provides insufficient evidence to determine the efficacy of convalescent plasma use as a therapeutic option for critically ill COVID-19 patients.

scholarly journals Review of COVID-19 mRNA Vaccines: BNT162b2 and mRNA-1273

2021 ◽  
pp. 089719002110096
Author(s):  
Shyh Poh Teo
Keyword(s):  
Vaccine Development ◽  
Safety Data ◽  
The United States ◽  
Virus Infections ◽  
Phase 3 ◽  
Vaccination Programs ◽  
Safety Surveillance ◽  
Mass Immunization ◽  
United States Food ◽  
States Food

The United States Food and Drug Administration recently issued emergency use authorization for 2 mRNA vaccines for preventing COVID-19 disease caused by SARS-CoV-2 virus infections. BNT162b2 from Pfizer-BioNTech and mRNA-1273 by Moderna are planned for use in mass-immunization programs to curb the pandemic. A brief overview of COVID-19 mRNA vaccines is provided, describing the SARS-CoV-2 RNA, how mRNA vaccines work and the advantages of mRNA over other vaccine platforms. The Pfizer-BioNTech collaboration journey to short-list mRNA vaccine candidates and finally selecting BNT162b2 based on safety data is outlined, followed by the Phase 3 study of BNT162b2 demonstrating 95% efficacy in preventing COVID-19 infections. Studies regarding mRNA-1273 (Moderna) are described, including extended immunogenicity data up to 119 days. The Phase 3 COVE study of mRNA-1273 eventually showed vaccine efficacy of 94.5%. Recommendations for future mRNA vaccine development are provided, including ongoing safety surveillance, evaluation in under-represented groups in previous studies and improving mRNA vaccine thermostability. Finally, further logistical considerations are required for manufacturing, storing, distribution and implementing mass vaccination programs to curb the pandemic.

scholarly journals New Insights into the Pathogenesis of Systemic Mastocytosis

2021 ◽  
Vol 22 (9) ◽  
pp. 4900
Author(s):  
Zhixiong Li
Keyword(s):  
Molecular Mechanisms ◽  
Kinase Inhibitor ◽  
Systemic Mastocytosis ◽  
Treatment Strategies ◽  
The United States ◽  
European Medicines Agency ◽  
Myeloid Neoplasm ◽  
Organ Systems ◽  
United States Food ◽  
Kit D816v

Mastocytosis is a type of myeloid neoplasm characterized by the clonal, neoplastic proliferation of morphologically and immunophenotypically abnormal mast cells that infiltrate one or more organ systems. Systemic mastocytosis (SM) is a more aggressive variant of mastocytosis with extracutaneous involvement, which might be associated with multi-organ dysfunction or failure and shortened survival. Over 80% of patients with SM carry the KIT D816V mutation. However, the KIT D816V mutation serves as a weak oncogene and appears to be a late event in the pathogenesis of mastocytosis. The management of SM is highly individualized and was largely palliative for patients without a targeted form of therapy in past decades. Targeted therapy with midostaurin, a multiple kinase inhibitor that inhibits KIT, has demonstrated efficacy in patients with advanced SM. This led to the recent approval of midostaurin by the United States Food and Drug Administration and European Medicines Agency. However, the overall survival of patients treated with midostaurin remains unsatisfactory. The identification of genetic and epigenetic alterations and understanding their interactions and the molecular mechanisms involved in mastocytosis is necessary to develop rationally targeted therapeutic strategies. This review briefly summarizes recent developments in the understanding of SM pathogenesis and potential treatment strategies for patients with SM.

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