Seventeen years since rimonabant's downfall: reassessing its suicidality risk profile.
Obesity (Silver Spring)
; 32(7): 1235-1244, 2024 07.
Article
de En
| MEDLINE
| ID: mdl-38887179
ABSTRACT
Targeting the cannabinoid type 1 receptor (CB1) is a clinically validated antiobesity therapeutic approach. The only such drug approved, rimonabant, was launched in 2006 in Europe but subsequently rejected by the US Food and Drug Administration (FDA) in 2007. The FDA cited the increased risk of suicidality in its opposition to rimonabant's approval, leading to the drug's eventual worldwide withdrawal and the abandonment of this class of therapeutics. Seventeen years later, a new class of CB1-targeting drugs is emerging, but the impact of the 2007 FDA decision remains a formidable obstacle to its clinical development. We revisit the suicidality data presented by the FDA in light of the evolution of suicidality assessment and cross-reference this with the data in the subsequently published clinical trials. We conclude that the publicly available data do not support the FDA's conclusion that the use of rimonabant was associated with an increase in the risk of suicidality.
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Suicide
/
Food and Drug Administration (USA)
/
Agents antiobésité
/
Rimonabant
Limites:
Humans
Pays/Région comme sujet:
America do norte
Langue:
En
Journal:
Obesity (Silver Spring)
Sujet du journal:
CIENCIAS DA NUTRICAO
/
FISIOLOGIA
/
METABOLISMO
Année:
2024
Type de document:
Article
Pays d'affiliation:
États-Unis d'Amérique
Pays de publication:
États-Unis d'Amérique