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.

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.

scholarly journals SUNSCREENS: DEVELOPMENTS AND CHALLENGES

2018 ◽  
Vol 10 (6) ◽  
pp. 54 ◽  
Author(s):  
P. Swathi Reddy ◽  
Aishwarya Suresh Kumar ◽  
Vikas Jain
Keyword(s):  
Ultra Violet ◽  
The United States ◽  
Human Populations ◽  
European Guidelines ◽  
Skin Cancers ◽  
United States Food ◽  
Subsequent Choice ◽  
Photo Damage ◽  
States Food ◽  
Food And Drugs Administration

One of the major concerns affecting the human skin is the exposure to ultra-violet radiations (UVR) causing photo-damage and skin cancers. In order to provide preventive measures against such incidences, there is an increased demand for sun-protectants. Sun screening agents have shown beneficiary effects on the skin by reducing the exposure of UVR and its associated symptoms. Although various constituents have been recognized to have sun protecting activity, their safety and efficacy is still a concern. The United States Food and Drugs Administration (USFDA) and European Guidelines (EU) guidelines have made the sun protecting factor (SPF) and other such indices compulsory on the labels of such formulas to guide the consumers for better selection. The various ranges of radiations and skin types influence the mechanism of photoreaction and subsequent choice of the formulation. Apart from existing agents, certain novel sun-screening agents and technologies are now available to provide better protection to human populations.

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 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.

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.

Adverse drug event reports at the United States Food and Drug Administration Center for Veterinary Medicine

2004 ◽  
Vol 225 (4) ◽  
pp. 533-536 ◽  
Author(s):  
Victoria A. Hampshire ◽  
Frederick M. Doddy ◽  
Lynn O. Post ◽  
Teresa L. Koogler ◽  
Tina M. Burgess ◽  
...  
Keyword(s):  
United States ◽  
Veterinary Medicine ◽  
Drug Administration ◽  
Adverse Drug Event ◽  
Food And Drug Administration ◽  
The United States ◽  
Drug Event ◽  
United States Food ◽  
States Food

scholarly journals Availability of Authorizations from EMA and FDA for Age-Appropriate Medicines Contained in the WHO Essential Medicines List for Children 2019

Pharmaceutics ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 316 ◽  
Author(s):  
Jose-Manuel delMoral-Sanchez ◽  
Isabel Gonzalez-Alvarez ◽  
Marta Gonzalez-Alvarez ◽  
Andres Navarro-Ruiz ◽  
Marival Bermejo
Keyword(s):  
Drug Product ◽  
Essential Medicines ◽  
World Health ◽  
European Medicines Agency ◽  
Drug Products ◽  
United States Food ◽  
Age Appropriate ◽  
States Food ◽  
Health Organization ◽  
Medicines For Children

Lack of age-appropriate commercially drug products availability is a common problem in pediatric therapeutics; this population needs improved and safer drug delivery. In addition, biopharmaceutic aspects, dosage requirements, and swallowing abilities demand pediatric forms different to adult formulations. The objective of this study was to evaluate the authorization availability from United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) of oral essential medicines for children and analyze its age-appropriateness for oral administration in children. All oral drugs from 7th List of Essential Medicines for Children by World Health Organization (WHO) were selected. Availability of commercial drug products was collected from OrangeBook, Spanish drug product catalogue, British electronic Medicines Compendium, and the International Vademecum. Tablets, effervescent tablets, and capsules were considered as not age-appropriate forms. Liquid forms, powder for oral suspension, mini tablets, granules, and soluble films were considered as age-appropriate forms due to their flexibility. More than 80% of the studied drugs possess a commercial authorization in oral forms in both EMA and FDA. Nevertheless, around 50% of these formulations are not age-appropriate for most pediatric groups. This study shows the lack of age-appropriate medicines for children. More efforts are needed to improve development and approval of pediatric medicines.

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