在欧洲国家对未经许可的大麻二醇进行药监
Fabrizio Calapai1,2, Emanuela Esposito1, Ilaria Ammendolia1,2
1Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy.
Phytotherapy research : PTR
|October 6, 2023
概括
未经许可的大麻二醇 (CBD) 产品显示出令人担忧的安全性,严重的不良反应在男性和成年人中更频繁. 治疗是一种常见的方法,但与精神和肝脏疾病有关.
科学领域:
- 药物监督 药物监督 药物监督
- 对于大麻素的研究
背景情况:
- 大麻素 (CBD) 已被认为具有抗炎和抗氧化作用.
- 未经许可的CBD产品非常受欢迎,用于一般健康,疼痛,焦虑和睡眠问题.
- 未经许可的CBD产品的安全性需要进一步调查.
研究的目的:
- 分析与未经许可的CBD产品相关的疑似不良反应 (SAR).
- 为了确定患者的人口统计,适应症和与严重SARS相关的联合使用药物.
主要方法:
- 在EudraVigilance报告的未经许可的CBD产品严重的SARS的分析.
- 评估的数据包括患者的年龄,性别,不良反应,使用指示和同时服用的药物.
主要成果:
- 严重的SARS占所有与未经许可的CBD相关的不良事件的18.9%.
- 与妇女和儿童相比,SARS在成年男性 (58.8%的严重报告) 中更为普遍.
- (38.8%) 是一个常见的征兆,精神障碍,肝脏问题和恶化作为常见的不良反应.
- 克洛巴赞,瓦尔酸和大麻是常见的同时使用的物质.
结论:
- 未经许可的CBD产品存在潜在的安全问题.
- 在使用未经许可的CBD时,提高警和监测不良影响至关重要.
- 对CBD产品安全性的进一步研究是有必要的.
相关概念视频
Pharmacovigilance
866
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
866
Drug Control Governance: Regulatory Bodies and Their Impact
170
Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
170
Drug Regulation
1.4K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.4K
Prescription, Nonprescription and Orphan Drugs
748
Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
748
Preclinical Development: Overview
4.5K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
4.5K
Chemotherapy-Induced Nausea and Vomiting: Cannabinoids
292
Tetrahydrocannabinol (THC) is a phytocannabinoid that primarily interacts with the CB1 receptor, a type of G protein-coupled receptor (GPCR) predominantly in and around the chemoreceptor trigger zone (CTZ) and emetic center. THC also blocks the serotonin receptor activity in the dorsal vagal complex (DVC) by inhibiting serotonin release. THC exerts its anti-emetic effects through these interactions, which are beneficial for patients undergoing chemotherapy.
Two synthetic agonists of THC,...
Two synthetic agonists of THC,...
292


