scholarly journals Cannabinoids in the Treatment of Epilepsy: A Review

2021 ◽  
Author(s):  
Daniel Zhou ◽  
Erin Dennis ◽  
Isha Snehal ◽  
Arun Swaminathan
Keyword(s):  
Drug Administration ◽  
Seizure Control ◽  
Refractory Epilepsy ◽  
Great Depth ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Comprehensive Description ◽  
Cognitive Changes ◽  
Treatment Of Epilepsy ◽  
Potential Benefits ◽  
The U.S

Cannabinoids have been studied for their role in the treatment of epilepsy for many years. The U.S. Food and Drug Administration (FDA) approved them for the treatment of some refractory syndromes in 2018. Cannabidiol and tetrahydrocannabinol are the most commonly studied cannabinoids and have been studied in great depth vis-à-vis their pharmacokinetics and pharmacodynamics. Studies have shown the efficacy of cannabinoids in the treatment of refractory epilepsy. A substantial amount of research has been performed exploring the interactions between cannabinoids and other conventional antiseizure medications. The exact mechanisms by which cannabinoids exert their effects on seizure control remain unclear and research into these mechanisms continues in great earnest. Cognitive changes from cannabinoids are constantly being studied and add to potential benefits from the use of these compounds. Cultural and social misconceptions and roadblocks about the use of cannabinoids persist and represent an ongoing obstacle to increasing research and therapeutic use of these compounds. This review focuses on all these aspects and of the use of these cannabinoids in the treatment of epilepsy and seeks to offer a fairly comprehensive description of the facets of cannabinoid therapy for refractory epilepsy.

International Harmonization of Food and Nutrition Regulation: The Good and the Bad

2003 ◽  
Vol 22 (1) ◽  
pp. 102-110 ◽  
Author(s):  
Paula Fitzgerald Bone ◽  
Karen Russo France
Keyword(s):  
Drug Administration ◽  
International Organizations ◽  
Food And Drug Administration ◽  
Research Focus ◽  
International Harmonization ◽  
Food And Nutrition ◽  
Potential Benefits ◽  
Negative Impacts ◽  
Global Food ◽  
The U.S

Researchers have long been interested in food and nutrition regulations. Such regulations, however, expand beyond the typical research focus on the U.S. Food and Drug Administration. Several international organizations play a role in global food and nutrition regulations. The authors discuss the issues revolving around harmonization of food and nutrition regulations and discuss the potential benefits and negative impacts of this process.

Percutaneous endoscopic gastrostomy for refractory epilepsy and medication refusal

2019 ◽  
Vol 104 (7) ◽  
pp. 690-692 ◽  
Author(s):  
Caoimhe Howard ◽  
William L Macken ◽  
Ann Connolly ◽  
Maria Keegan ◽  
David Coghlan ◽  
...  
Keyword(s):  
Percutaneous Endoscopic Gastrostomy ◽  
Seizure Control ◽  
Refractory Epilepsy ◽  
Case Series ◽  
Oral Feeding ◽  
Tube Placement ◽  
Endoscopic Gastrostomy ◽  
Potential Benefits ◽  
Peg Tube ◽  
Hiv Renal Disease

ObjectiveCurrent guidelines for percutaneous endoscopic gastrostomy (PEG) placement focus largely on maintaining enteral feeding when oral feeding is no longer possible or adequate with an emphasis on nutrition and quality of life (QOL). Previous publications have also alluded to potential benefits in medication adherence, for example, in children with HIV, renal disease and neurodisability. We describe a cohort of children with refractory epilepsy who refused oral medication and in whom PEG tube placement was initiated for the purpose of drug administration.DesignWe identified children from the medical records of two tertiary paediatric units over a 9-year period who had PEG tube placement for administration of antiepileptic drug (AED) therapy and collected demographic and clinical details from chart reviews. We assessed parent-reported changes in seizure control and QOL using a structured questionnaire.ResultsTen patients met the inclusion criteria. All families reported an improvement in ease of administering medications and eight reported a significant improvement in QOL. Nine children had a decrease in seizure frequency (lasting more than 12 months) following PEG tube placement, including two who underwent surgical intervention for their epilepsy during that period. Four had either a decrease in the number of drugs administered or their doses and four went on to receive fluids and nutrition through their tube on a regular basis. Seven reported PEG complications, which did not require removal of the PEG.ConclusionsThis case series of children with resistant epilepsy demonstrates improvement in seizure control and QOL following PEG tube placement for AED administration.

Seizures following surgery for supratentorial extratemporal low-grade tumors in children: a multicenter retrospective study

2020 ◽  
Vol 26 (1) ◽  
pp. 27-33
Author(s):  
Jonathan Roth ◽  
Or Bercovich ◽  
Ashton Roach ◽  
Francesco T. Mangano ◽  
Arvind C. Mohan ◽  
...  
Keyword(s):  
Retrospective Study ◽  
Brain Tumors ◽  
Seizure Control ◽  
Seizure Activity ◽  
Refractory Epilepsy ◽  
Low Grade ◽  
Refractory Seizures ◽  
Low Rate ◽  
Over Time ◽  
New Onset

OBJECTIVEResection of brain tumors may lead to new-onset seizures but may also reduce seizure rates in patients presenting with seizures. Seizures are seen at presentation in about 24% of patients with brain tumors. For lesional epilepsy in general, early resection is associated with improved seizure control. However, the literature is limited regarding the occurrence of new-onset postoperative seizures, or rates of seizure control in those presenting with seizures, following resections of extratemporal low-grade gliomas (LGGs) in children.METHODSData were collected retrospectively from 4 large tertiary centers for children (< 18 years of age) who underwent resection of a supratentorial extratemporal (STET) LGG. The patients were divided into 4 groups based on preoperative seizure history: no seizures, up to 2 seizures, more than 2 seizures, and uncontrolled or refractory epilepsy. The authors analyzed the postoperative occurrence of seizures and the need for antiepileptic drugs (AEDs) over time for the various subgroups.RESULTSThe study included 98 children. Thirty patients had no preoperative seizures, 18 had up to 2, 16 had more than 2, and 34 had refractory or uncontrolled epilepsy. The risk for future seizures was higher if the patient had seizures within 1 month of surgery. The risk for new-onset seizures among patients with no seizures prior to surgery was low. The rate of seizures decreased over time for children with uncontrolled or refractory seizures. The need for AEDs was higher in the more active preoperative seizure groups; however, it decreased with time.CONCLUSIONSThe resection of STET LGGs in children is associated with a low rate of postoperative new-onset epilepsy. For children with preoperative seizures, even with uncontrolled epilepsy, most have a significant improvement in the seizure activity, and many may be weaned off their AEDs.

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

scholarly journals Keto-Sleuths – An Unusual Cause of Loss of Ketosis?

2021 ◽  
Vol 8 ◽  
pp. 2329048X2110297
Author(s):  
Christine M. Foley ◽  
Christopher Ryan ◽  
Stacey Tarrant ◽  
Ann M. Bergin
Keyword(s):  
Effective Treatment ◽  
Seizure Control ◽  
Refractory Epilepsy ◽  
Clinical Scenario ◽  
Diet Restriction ◽  
Ketogenic Diets ◽  
Control And Prevention

Ketogenic diets provide a non-pharmaceutical alternative for treatment of refractory epilepsy. When successful in reducing or eliminating seizures, medication numbers or doses may be reduced. Unexpected loss of ketosis is a common problem in management of patients on ketogenic diets and, especially when the diet is an effective treatment, loss of ketosis may be associated with an exacerbation in seizures. Identification of the cause of loss of ketosis is critical to allow rapid resumption of seizure control, and prevention of unnecessarily increased diet restriction or increased medication doses. Here an unusual environmental cause of loss of ketosis is described (contamination with starch-containing drywall dust), illustrating the extent of investigation sometimes necessary to understand the clinical scenario.

The U.S. Food and Drug Administration’s Complex Innovative Trial Design Pilot Meeting Program: Progress to date

2021 ◽  
pp. 174077452110505
Author(s):  
Dionne Price ◽  
John Scott
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Trial Design ◽  
Drug Evaluation ◽  
Food And Drug Administration ◽  
Medical Product ◽  
Global Public Health ◽  
Multiple Sources ◽  
Meeting Program ◽  
The U.S

Background The Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research of the U.S. Food and Drug Administration have been leaders in advancing science to protect and promote public health by ensuring that safe and effective drugs and biological products are available to those who need them. Recently, new therapeutic discoveries, increased understanding of disease mechanisms, the need for innovation to optimally use resources, and global public health crises have led to an evolving drug development landscape. As a result, the U.S. Food and Drug Administration and medical product developers are faced with unique challenges and opportunities. The U.S. Food and Drug Administration is proactively meeting the challenges of this evolving landscape through various efforts, including the Complex Innovative Trial Design Pilot Meeting Program. Our focus, here, will be on the pilot meeting program. Methods The U.S. Food and Drug Administration has defined a process to facilitate the implementation of the Complex Innovative Trial Design Pilot Meeting Program. The process is transparent and outlines the steps and timeline for submission, review, and meetings. Results Five submitted meeting requests have been selected for participation in the Complex Innovative Trial Design Pilot Meeting Program. Conclusion The pilot meeting program has been successful in further educating stakeholders on the potential uses of complex innovative designs in trials intended to provide substantial evidence of effectiveness. The selected submissions, thus far, have all utilized a Bayesian framework. The reasons for the use of Bayesian approaches may be due to the flexibility provided, the ability to incorporate multiple sources of evidence, and a desire to better understand the U.S. Food and Drug Administration perspective on such approaches. We are confident the pilot meeting program will have continued success and impact the collective goal of bringing safe and effective medical products to patients.

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