Potassium binders

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.

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Potassium binders

ESC CardioMed ◽

10.1093/med/9780198784906.003.0042_update_001 ◽

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.

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Nephrogenic systemic fibrosis

Oxford Textbook of Rheumatology ◽

10.1093/med/9780199642489.003.0123 ◽

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.

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Developing Drugs for Prevention of Chemotherapy-Induced Nausea and Vomiting: Draft Guidance from the United States Food and Drug Administration

Clinical Cancer Research ◽

10.1158/1078-0432.ccr-21-1941 ◽

2021 ◽

pp. clincanres.1941.2021

Author(s):

Erica Lyons ◽

Charles Line ◽

Jessica J Lee

Keyword(s):

United States ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Nausea And Vomiting ◽

Draft Guidance ◽

United States Food ◽

States Food

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Effects of hypoxia and glutathione depletion on hemoglobin- and myoglobin-mediated oxidative stress toward endothelium1The opinions and assertions contained herein are the scientific views of the authors and are not to be construed as policy of the United States Food and Drug Administration or the United States Army.1

Biochimica et Biophysica Acta (BBA) - Molecular Cell Research ◽

10.1016/s0167-4889(99)00163-9 ◽

2000 ◽

Vol 1495 (2) ◽

pp. 150-159 ◽

Cited By ~ 28

Author(s):

Felice D’Agnillo ◽

Francine Wood ◽

Carlos Porras ◽

Victor W. Macdonald ◽

Abdu I. Alayash

Keyword(s):

Oxidative Stress ◽

United States ◽

United States Army ◽

Drug Administration ◽

Food And Drug Administration ◽

The United States ◽

Glutathione Depletion ◽

United States Food ◽

States Food

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Harmonization by Doing Proposal for Global Clinical Trial Designs for Endovascular Devices for Treatment of Critical Limb Ischemia: The United States Food and Drug Administration Perspective

Circulation Journal ◽

10.1253/circj.cj-18-0817 ◽

2018 ◽

Vol 82 (12) ◽

pp. 3110-3111

Author(s):

Kenneth J. Cavanaugh Jr ◽

Donna C. Buckley ◽

Misti L. Malone

Keyword(s):

United States ◽

Clinical Trial ◽

Critical Limb Ischemia ◽

Limb Ischemia ◽

The United States ◽

Global Clinical Trial ◽

United States Food ◽

States Food ◽

Clinical Trial Designs ◽

Endovascular Devices

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Differentiation between the Regulatory paths placed on Mouthwashes in the US and EU

International Journal of Drug Regulatory Affairs ◽

10.22270/ijdra.v6i2.229 ◽

2018 ◽

Vol 6 (2) ◽

pp. 8-13

Author(s):

Philip Saddik ◽

John Pappan

Keyword(s):

United States ◽

The United States ◽

The European Union ◽

Oral Diseases ◽

External Appearance ◽

Regulatory Systems ◽

The Us ◽

United States Food ◽

States Food ◽

Therapeutic Properties

Regulating oral rinses has been and still is a topic of debate and confusion. Oral rinses are products that are mainly used for cleaning, perfuming and changing the appearance of the teeth, which in turn improves the individual’s external appearance. Adding medicinal ingredients to these rinses, it can then be used for the elimination and/or prevention of some oral diseases, an example being gingivitis. The United States Food and Drug Administration placed guidelines which state that mouthwashes with possible therapeutic properties should be registered as drugs rather than cosmetics. Meanwhile, on a different continent, Germany along with the other members of the European Union decided not to categorize mouthwashes as drugs, but rather as cosmetics, using its sole purpose of cleaning and beautifying the teeth as the excuse. The following research will thoroughly differentiate between the diverse regulatory systems forced upon mouthwashes across the two countries—the United States and Germany.

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Analysis of Crowdsourced Metformin Tablets from Individuals Reveals Widespread Contamination with N-Nitrosodimethylamine (NDMA) in the United States

10.1101/2020.05.22.20110635 ◽

2020 ◽

Cited By ~ 1

Author(s):

Qian Wu ◽

Evgenia Kvitko ◽

Amber Jessop ◽

Shannon Williams ◽

Ryan C. Costantino ◽

...

Keyword(s):

United States ◽

High Resolution Mass Spectrometry ◽

Daily Intake ◽

The United States ◽

Product Recalls ◽

Acceptable Daily Intake ◽

Drug Products ◽

Post Market ◽

United States Food ◽

States Food

AbstractRecent reports of metformin drug products contaminated with unacceptable levels of the probable human carcinogen N-Nitrosodimethylamine (NDMA) prompted a national sampling of post-market metformin drug products. To most broadly sample the market and minimize supply chain bias, metformin medication samples were crowdsourced directly from individuals across many states in the United States. 128 samples were received, and liquid chromatography-high resolution mass spectrometry tests for a panel of nitrosamines revealed significant levels of NDMA that trend with labeling company. 42% of all medication samples contained detectable levels of NDMA and, when scaled to maximum daily tablet dose, 36% of all medication samples contained NDMA levels exceeding the FDA daily acceptable intake limit. The highest NDMA detection from the tested samples was 1565 ng per tablet, which, when commonly taken four times a day, is 65 times the United States Food and Drug Administration (FDA) acceptable daily intake limit. Results underscore the need for immediate product recalls of tainted medications and an overall investigation of metformin manufacturing practices.

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