scholarly journals Respiratory concerns of gabapentin and pregabalin: What does it mean to the pharmacovigilance systems in developing countries?

F1000Research ◽  
2021 ◽  
Vol 9 ◽  
pp. 32
Author(s):  
Sunil Shrestha ◽  
Subish Palaian
Keyword(s):  
United States ◽  
Developing Countries ◽  
Early Detection ◽  
Evaluation Studies ◽  
The United States ◽  
Drug Reactions ◽  
Prescription Monitoring ◽  
Concurrent Use ◽  
United States Food ◽  
States Food

Gabapentin and pregabalin, commonly known as gabapentinoids, have been widely used globally. This paper highlights the serious breathing problems due to using gabapentin and pregabalin which was warned by the United States Food and Drug Administration on December, 2019. In this article, we tried to recommend suggestions for controlling these adverse drug reactions (ADRs). Safety reports of gabapentin and pregabalin should be obtained from concerned manufacturers and reviewed for respiratory depression effects. There should be strict prescription monitoring and drug use evaluation studies. Concurrent use of gabapentin and pregabalin with other respiratory depressants such as opioids should be strictly monitored. Educating patients can help in the early detection of ADRs due to gabapentin and pregabalin. Anecdotal reports on these medications should be encouraged.

scholarly journals Respiratory concerns of gabapentin and pregabalin: What does it mean to the pharmacovigilance systems in developing countries?

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 32
Author(s):  
Sunil Shrestha ◽  
Subish Palaian
Keyword(s):  
United States ◽  
Developing Countries ◽  
Early Detection ◽  
Evaluation Studies ◽  
The United States ◽  
Drug Reactions ◽  
Prescription Monitoring ◽  
Concurrent Use ◽  
United States Food ◽  
States Food

Gabapentin and pregabalin, commonly known as gabapentinoids, have been widely used globally. This paper highlights the serious breathing problems due to using gabapentin and pregabalin which was warned by the United States Food and Drug Administration on December, 2019. In this article, we tried to recommend suggestions for controlling these adverse drug reactions (ADRs). Safety reports of gabapentin and pregabalin should be obtained from concerned manufacturers and reviewed for respiratory depression effects. There should be strict prescription monitoring and drug use evaluation studies. Concurrent use of gabapentin and pregabalin with other respiratory depressants should be strictly monitored. Educating patients can help in the early detection of ADRs due to gabapentin and pregabalin. Anecdotal reports on these medications should be encouraged.

Nonprescription Drugs: An Overview

1974 ◽  
Vol 4 (1) ◽  
pp. 125-130 ◽  
Author(s):  
Benjamin Hodes
Keyword(s):  
United States ◽  
The United States ◽  
Health Practitioner ◽  
Drug Reactions ◽  
Nonprescription Drugs ◽  
Safety And Efficacy ◽  
United States Food ◽  
Deceptive Advertising ◽  
States Food ◽  
Regulatory Actions

This article discusses a widely used class of medicinal agents—nonprescription drugs. The pertinent legislation affecting nonprescription drugs is reviewed historically, followed by a discussion of recent federal regulatory actions, especially those of the review panels convened by the United States Food and Drug Administration. The problems associated with nonprescription drugs are considered from the viewpoints of the health practitioner, the consumer, and the federal regulatory agency, taking into account such concerns as drug interactions, adverse drug reactions, overuse, and deceptive advertising. Finally, some problems in the assessment of the safety and efficacy of nonprescription drugs are discussed.

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

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.

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

2020 ◽  
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.

Program planning with Tobit analysis—the United States food stamp case

1980 ◽  
Vol 14 (2) ◽  
pp. 91-95
Author(s):  
J.E. Epperson ◽  
M.R. Holmes ◽  
C.L. Huang ◽  
W.K. Scearce
Keyword(s):  
United States ◽  
Program Planning ◽  
The United States ◽  
Food Stamp ◽  
Tobit Analysis ◽  
United States Food ◽  
States Food
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