来自德国和美国在线药店的含有维生素A的食补充剂:市场和风险评估
Anna-Miriam Rathmann1, Roland Seifert2
1Institute of Pharmacology, Hannover Medical School, D-30625, Hannover, Germany.
Naunyn-Schmiedeberg's archives of pharmacology
|March 28, 2024
概括
高剂量的维生素A补充剂由于监管和标签不足而带来风险. 许多产品超过了安全限值,特别是在德国,这表明需要对这些食品补充剂进行更严格的监督.
科学领域:
- 营养科学 营养科学
- 公共卫生 公共卫生
- 监管科学 监管科学
背景情况:
- 维生素A补充剂越来越多地作为食品而不是药品,导致控制不那么严格.
- 关于安全摄入维生素A的现有建议来自BfR和FDA等机构是无约束力的,增加了过量服用的风险.
- 高剂量的维生素A与已知的风险,如肝毒性和致病性有关,但强效补充剂仍然广泛可获得.
研究的目的:
- 评估德国和美国可用的维生素A补充剂的风险潜力.
- 评估是否符合标签要求,并将剂量与专家建议进行比较.
- 调查对维生素A补充剂的加强监测和更严格的监管的需要.
主要方法:
- 对来自德国的75种维生素A补充剂和来自美国的26种维生素A补充剂进行了批判性审查.
- 分析参数包括制造商推的每日剂量,每日治疗费用,以及关于警告,怀孕使用和不良反应的信息.
- 产品剂量与既定专家建议和监管指南的比较.
主要成果:
- 在德国和美国的补充剂中发现了标签合规性的重大缺陷.
- 许多补充剂的剂量经常超过专家建议,造成潜在的健康风险.
- 美国的补充剂通常表现得比德国更好,这表明美国市场的监管更有效.
结论:
- 目前对维生素A补充剂的规定和标签不足,给消费者,特别是弱势群体带来风险.
- 没有确诊的缺乏症的维生素A补充剂的健康益处是可疑的.
- 可能需要更严格的监管监督和对维生素A补充剂的潜在重新分类.
更多相关视频
08:18Author Spotlight: Unraveling Vitamin A Transport Mechanisms — Linking Liver Receptors to Vision Health Through RBPR2 and RBP4 Interactions
Published on: October 4, 2024
1.1K
08:54NMR Spectroscopy as a Robust Tool for the Rapid Evaluation of the Lipid Profile of Fish Oil Supplements
Published on: May 1, 2017
26.2K
相关概念视频
Pharmacovigilance
830
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...
830
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
Vitamins
714
Vitamins, derived from the Latin word for life, are essential organic substances required in small quantities for optimal growth and overall well-being. Unlike other organic nutrients, vitamins don't act as sources of energy or building materials but rather facilitate these nutrients' utilization by the body. Vitamins are predominantly coenzymes, assisting enzymes in specific chemical actions, like the oxidation of glucose for energy involving B vitamins. Most vitamins are not produced...
714
Prescription, Nonprescription and Orphan Drugs
725
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...
725
Role of Skin in Vitamin D Synthesis
5.2K
The skin plays a crucial role in the synthesis of vitamin D, a vital nutrient for various physiological processes in the body. Vitamin D is unique because it can be synthesized in the skin through a series of chemical reactions triggered by exposure to ultraviolet B (UVB) radiation from sunlight.
The solar UV B rays (290-315 nm) are absorbed by the skin, and 7-dehydrocholesterol (provitamin D3) photolyzes it to previtamin D3, which undergoes a rapid transformation to vitamin...
The solar UV B rays (290-315 nm) are absorbed by the skin, and 7-dehydrocholesterol (provitamin D3) photolyzes it to previtamin D3, which undergoes a rapid transformation to vitamin...
5.2K
Clinical Trials: Overview
2.9K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
2.9K
