Therapeutic advances in drug safety
January 1, 2025
Carlos Roncero, Milton Merizalde-Torres, Néstor Szerman et al.
11 citations
Intranasal esketamine, approved in 2019 for treatment-resistant depression, effectively alleviates depressive symptoms with benefits lasting nearly 4.5 years. Long-term clinical studies, case reports, and subsamples of high-risk populations with substance use or alcohol use disorder have not documented abuse, misuse, addiction, or withdrawal. Esketamine is safe and well tolerated without fostering new-onset substance use. Real-world studies report no adverse events from pharmacological interactions and no new-onset drug or alcohol misuse, craving, misuse, or diversion. Only one case report of esketamine craving exists (2022). No illicit acquisition or tampering was found. The review confirms esketamine's safety and the scarcity of abuse or misuse reports.
Therapeutic advances in drug safety
January 1, 2025
Gilmar Gutierrez, Gustavo Vazquez, Nisha Ravindran et al.
5 citations
Intranasal esketamine, used for treatment-resistant depression, does not appear to carry significant abuse liability during an acute course of treatment. In a secondary analysis of a multicenter observational study, 23 patients with major depressive disorder reported neutral liking and no cravings for esketamine after their first dosing session, and these measures did not increase over eight sessions. Neither age, sex, baseline depression severity, side effects, nor study site influenced liking or cravings. The findings align with existing literature suggesting that acute esketamine treatment is not associated with high drug liking or cravings, though larger studies are needed.
Therapeutic advances in drug safety
January 1, 2026
Ovie Martin Albert, Alexander Arthur
Human evidence on prenatal exposure to psychedelics such as MDMA, LSD, and mescaline is sparse and methodologically limited. A scoping review of 23 primary human studies (1968–2020) found no eligible pregnancy outcome studies for psilocybin or DMT/ayahuasca. The available evidence, mostly small cohorts and case reports, is constrained by self-reported exposure, polysubstance use, and inconsistent outcome definitions. Clinicians should counsel patients with explicit acknowledgment of uncertainty while supporting harm reduction. The absence of data for several substances should not be interpreted as evidence of safety, and structured pharmacovigilance is needed as therapeutic psychedelic research expands.