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.

Protecting the Consumer From Getting Burned: the FDA, the Administrative Process, and the Tentative Final Monograph on Over-the-Counter Sunscreens

1994 ◽  
Vol 20 (3) ◽  
pp. 317-335
Author(s):  
Patrick R. Jones
Keyword(s):  
Skin Cancer ◽  
The United States ◽  
The Sun ◽  
Over The Counter ◽  
Administrative Process ◽  
Skin Cancers ◽  
United States Food ◽  
Life Threatening ◽  
States Food ◽  
Regulatory Scrutiny

As consumers have become enlightened to the dangers of the sun, they have turned increasingly to sunscreens to stave off not only a sunburn but also life-threatening skin cancer. In the last decade, the incidence of skin cancer has grown a startling 500%. The increase in the number of skin cancers in adults is most likely the result of exposure to the sun as a child. Therefore, the current and continued rise in the number of skin cancers in adults is not remediable. However, as adult consumers seek to prevent further damage to their skin and protect their children from the same fate, the market for sunscreens has grown and is estimated to be worth between $170 and $650 million dollars. The increased demand for sunscreens, combined with the incorporation of sunprotection ingredients into everyday products such as makeup and skin lotions, has led the United States Food and Drug Administration (FDA) to subject sunscreens to increased regulatory scrutiny.

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 Botulinum toxin in the management of chronic migraine: clinical evidence and experience

2016 ◽  
Vol 10 (2) ◽  
pp. 127-135 ◽  
Author(s):  
Claus M Escher ◽  
Lejla Paracka ◽  
Dirk Dressler ◽  
Katja Kollewe
Keyword(s):  
Chronic Migraine ◽  
Botulinum Neurotoxin ◽  
Prophylactic Treatment ◽  
Clinical Evidence ◽  
The United States ◽  
Headache Frequency ◽  
United States Food ◽  
History Of ◽  
States Food ◽  
Review Reports

Chronic migraine (CM) is a severely disabling neurological condition characterized by episodes of pulsating unilateral or bilateral headache. The United States Food and Drug Administration (FDA) approved onabotulinumtoxinA (Botox®) for the prophylactic treatment of CM in 2010. It has been shown that onabotulinumtoxinA is effective in the reduction of headache frequency and severity in patients with CM. Treatment is well tolerated by the patients. This review reports on the history of botulinum neurotoxin (BoNT) in CM and presents the current clinical evidence for the use of onabotulinumtoxinA in the treatment of CM.

scholarly journals Clinical Development of Biological Response Modifiers

1994 ◽  
Vol 5 (suppl a) ◽  
pp. 5A-8A
Author(s):  
Jay P Siegel
Keyword(s):  
Adverse Reactions ◽  
Biological Response ◽  
Clinical Trial Design ◽  
The United States ◽  
Biological Response Modifier ◽  
Clinical Development ◽  
Response Modifier ◽  
United States Food ◽  
Study Population ◽  
States Food

OBJECTIVE: To present perspectives on selected issues that frequently arise during the clinical development of biological response modifier (BRM) therapies.DATA SOURCES: The perspectives and opinions presented herein were developed over several years of reviewing and consulting on the clinical development of BRM therapies at the United States Food and Drug Administration.CONCLUSIONS: BRM therapies encompass a broad spectrum of products used to treat a wide variety of diseases. Due to this diversity. most principles of clinical trial design and conduct applicable to the majority of BRMS are those that are applicable to all therapies. Nevertheless, the clinical development of BRM therapies often raises specific issues and problems in the areas of selecting animal models, defining the study population, adverse reactions, dosing and defining end-points. Over 10 years’ experience in testing biotechnology derived BRMS in clinical trials has created a database from which we can draw valuable generalizations for guidance in future studies.

Safety assessment of natural products in Malaysia: current practices, challenges, and new strategies

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Nur Azra M. Pauzi ◽  
Manraj S. Cheema ◽  
Amin Ismail ◽  
Ahmad Rohi Ghazali ◽  
Rozaini Abdullah
Keyword(s):  
Natural Products ◽  
Animal Studies ◽  
Regulatory System ◽  
The United States ◽  
Regulatory Control ◽  
Health Maintenance ◽  
Traditional Medicines ◽  
Aristolochic Acids ◽  
United States Food ◽  
States Food

Abstract The belief that natural products are inherently safe is a primary reason for consumers to choose traditional medicines and herbal supplements for health maintenance and disease prevention. Unfortunately, some natural products on the market have been found to contain toxic compounds, such as heavy metals and microbes, as well as banned ingredients such as aristolochic acids. It shows that the existing regulatory system is inadequate and highlights the importance of thorough safety evaluations. In Malaysia, the National Pharmaceutical Regulatory Agency is responsible for the regulatory control of medicinal products and cosmetics, including natural products. For registration purpose, the safety of natural products is primarily determined through the review of documents, including monographs, research articles and scientific reports. One of the main factors hampering safety evaluations of natural products is the lack of toxicological data from animal studies. However, international regulatory agencies such as the European Food Safety Authority and the United States Food and Drug Administration are beginning to accept data obtained using alternative strategies such as non-animal predictive toxicological tools. Our paper discusses the use of state-of-the-art techniques, including chemometrics, in silico modelling and omics technologies and their applications to the safety assessments of natural products.

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