ISSN 1474-0338, 1744-764X
19 papers in the library · 513 citations · publishing 2011-2026
Expert Opinion on Drug Safety August 28, 2026 Roger S McIntyre
1.0 According to the 2023 iteration of the Global Burden of Diseases, Injuries and Risk Factor studies (GBD) assessing 375 injuries and diseases and 12 mental disorders, mental disorders are now th...
Expert Opinion on Drug Safety February 19, 2026 Kyle Valentino, Kayla M Teopiz, Christine E. Dri et al.
1. Esketamine as monotherapy or adjunct to conventional antidepressants is proven efficacious in clinical trials in adults with treatment-resistant depression (TRD) and depression with high risk of...
Expert Opinion on Drug Safety April 24, 2025 Yingqiu Tu, Xin Lai, Qing Wan et al. 2 citations
This study aimed to analyze adverse drug events (ADEs) of oseltamivir or baloxavir marboxil monotherapy using the Food and Drug Administration Adverse Event Reporting System (FAERS) database, providing a valuable reference for clinical drug safety. FAERS data for oseltamivir and baloxavir marboxil from their market approval in the United States until the third quarter of 2023 were retrieved....
Expert Opinion on Drug Safety June 21, 2024 Roger S McIntyre, Rodrigo B. Mansur, Joshua D. Rosenblat et al. 7 citations
Replicated evidence indicates that ketamine and esketamine reduce measures of suicidality in persons with treatment-resistant depression (TRD). It remains uncertain whether individuals experience worsening of preexisting suicidality with either agent. The Food and Drug Administration Adverse Event Reporting System (FAERS) database was searched from 1970 and 2019 to 30 September 2023 for reports...
Expert Opinion on Drug Safety August 28, 2023 Roger S McIntyre 16 citations
KEYWORDS: Psychedelicpsilocybinlysergic acid diethylamidemood disordersantidepressantsdiscoverypharmacologyFDA
Expert Opinion on Drug Safety August 15, 2023 Roger S McIntyre 26 citations
KEYWORDS: PsilocybinLysergic acid diethylamide (LSD)ecstasyvalvular heart disease5HT2B receptor agonismFDA guidance
Expert Opinion on Drug Safety May 3, 2022 Danica Nogo, Hana Nazal, Yuetong Song et al. 17 citations
INTRODUCTION: Ketamine is an established intervention for treatment-resistant depression (TRD). However, long-term adverse effects with repeated doses remain insufficiently characterized. Although several animal models have shown N-methyl-D-aspartate glutamate receptor antagonists to produce various neuropathological reactions, attention surrounding the risk of brain lesions has been minimal....
Expert Opinion on Drug Safety April 27, 2022 M. Kritzer, C. Pae, P. Masand
ABSTRACT Introduction Racemic ketamine, a derivative of phencyclidine, has been used as a dissociative anesthetic since 1970. In 2000, the first randomized controlled trial showed a rapid relief of depressive symptoms. Since then, intravenous ketamine and intranasal S-ketamine have been validated for the treatment of depression and suicidal ideation following dose-response and double-blind...
Expert Opinion on Drug Safety April 15, 2022 Marcus A. Doyle, Susan Ling, Leanna M.W. Lui et al. 24 citations
INTRODUCTION: Hallucinogen persisting perception disorder (HPPD) affects a subset of persons who use hallucinogens and is defined as the repeated experience of hallucinations and other perceptual disturbances as a result of prior intoxications. As select hallucinogens are under development for the treatment of selectmental disorders, there is a need to better characterize this disorder. AREAS...
Expert Opinion on Drug Safety April 15, 2022 Giordano Novak Rossi, Jaime E. C. Hallak, José Carlos Bouso Saiz et al. 24 citations
There were no serious AEs related to psilocybin and LSD administration. Most AEs were expected, manageable, and transient. Nevertheless, safety and tolerability concerns regarding some effects, such as dissociation, paranoia, and confusion, remain. Thus, randomized controlled trials with bigger samples are warranted to confirm their therapeutic effects and further investigate their safety and...
Expert Opinion on Drug Safety April 13, 2022 Sina Nikayin, Eva Murphy, John H. Krystal et al. 114 citations
INTRODUCTION: Ketamine can produce rapid-acting antidepressant effects. Esketamine (Spravato), the S-enantiomer of racemic ketamine, was approved by the FDA for treatment-resistant depression in 2019. Here we review what is known about the long-term safety of both racemic ketamine and esketamine as therapies for psychiatric disorders. AREAS COVERED: In this article, we conducted a safety review...
Expert Opinion on Drug Safety April 6, 2022 Muhammad Youshay Jawad, Joshua D. Di Vincenzo, Felicia Ceban et al. 29 citations
INTRODUCTION: Intranasal (IN) esketamine represents an innovative treatment for individuals with treatment resistant depression and depression with suicidal ideation and behavior. Herein, we synthesize extant long-term studies (≥ 4 weeks) regarding this treatment. RESEARCH DESIGN AND METHODS: The interventional studies of IN esketamine in patients with depression having a study period of at...
Expert Opinion on Drug Safety April 6, 2022 M. I. Husain, M. Umer, Benoit H. Mulsant
Classic psychedelics are a loosely grouped class of drugs that activate serotonin 5HT2A receptors to induce complex behavioral, psychological, and physiological effects [1]; 5HT2A agonism induces the hallucinogenic experiences that distinguish psychedelics [2] while pre-medicating with a 5HT2A antagonist, such as ketanserin, prevents them [3,4]. In the 1950s and 1960s, after Albert Hoffman’s...
Expert Opinion on Drug Safety March 18, 2022 Giordano Novak Rossi, Isabella Caroline Da Silva Dias, Glen B. Baker et al. 17 citations
There were no reports of serious AEs, indicating a relative safety of ayahuasca administration in controlled settings. Most common AEs included nausea, vomiting, headaches, and transient increases in cardiovascular measurements. Ayahuasca research is still in its infancy, especially concerning the absence of large and robust clinical trials to verify its antidepressant effects. Dose...
Expert Opinion on Drug Safety March 9, 2022 Anees Bahji, Carlos A. Zarate, Gustavo Vazquez 71 citations
ABSTRACT Background Racemic ketamine and esketamine have demonstrated rapid antidepressant effects. We aimed to review the efficacy and safety of racemic and esketamine for depression. Research design and methods We conducted a PRISMA-guided review for relevant randomized controlled trials of racemic or esketamine for unipolar or bipolar major depression from database inception through 2021. We...
Expert Opinion on Drug Safety February 26, 2022 Jan Van Amsterdam, Wim van den Brink 74 citations
Psilocybin - mostly combined with psychotherapy or psychotherapeutic support - shows a promise as a treatment for various (treatment-resistant) mental disorders. Larger double-blind RCTs with objective (long-term) outcomes are needed to confirm these findings before standard clinical use of psilocybin can be considered.
Expert Opinion on Drug Safety June 26, 2021 Jan Van Amsterdam, Wim van den Brink 42 citations
BACKGROUNDS: Ketamine is a dissociative anesthetic that is currently considered for several new indications. AIM: To deduce the safety of long-term ketamine treatment using the harm of heavy recreational (non-medical) ketamine use as a proxy for maximal possible harm of ketamine treatment. METHODS: Systematic literature review according to PRISMA guidelines to identify controlled studies on...
Expert Opinion on Drug Safety June 15, 2020 Nelson B Rodrigues, Roger S McIntyre, Orly Lipsitz et al. 50 citations
ABSTRACT Objectives Rigorous clinical trials suggest ketamine is safe and well-tolerated in patients with treatment-resistant depression (TRD). There is a paucity of data on the safety and tolerability of ketamine in community-based clinics treating patients with TRD. Methods Retrospective data was analyzed from 203 patients with TRD who received repeat-dose IV ketamine. Safety was...
Expert Opinion on Drug Safety September 2011 Philip Robson
There is a growing consensus that cannabis dependence is a substantial and underappreciated problem. The key component responsible for the euphoric effects of cannabis and its dependence potential is δ-9-tetrahydrocannabinol (THC). THC-containing cannabinoid medicines theoretically pose a risk of abuse and dependence. In order to evaluate the potential of Sativex to cause cannabis-like...