PSUSA/00001088/202512 - Safety Update Amendments for Dimenhydrinate
Implement the updated product information by November 5, 2026, ensuring that all labeling and documentation includes the new warnings and risk profiles.
Primary source: Open Government Licence v3.0
Record seizure of 1,298kg of ketamine reported, marking a significant increase in regulatory enforcement related to drug control in the UK.
The high volume of seized ketamine indicates rising misuse, which is linked to serious health issues, necessitating closer monitoring and potential interventions to protect community health.
Monitor and evaluate the drug misuse trends and health impacts associated with ketamine, focusing on the increase in seizures as part of public health and law enforcement strategies.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Monitor and evaluate the drug misuse trends and health impacts associated with ketamine, focusing on the increase in seizures as part of public health and law enforcement strategies.
In the first quarter of 2026, Border Force seized 1,298kg of ketamine, the highest quarterly total in 15 years and a 42% increase compared to the last quarter of 2025. This surge in seizures suggests worsening misuse and potential public health risks, particularly among youth.
What changed: Record seizure of 1,298kg of ketamine reported, marking a significant increase in regulatory enforcement related to drug control in the UK.
Why it matters: The high volume of seized ketamine indicates rising misuse, which is linked to serious health issues, necessitating closer monitoring and potential interventions to protect community health.
Practical implication: Monitor and evaluate the drug misuse trends and health impacts associated with ketamine, focusing on the increase in seizures as part of public health and law enforcement strategies.
Published from the regulator source ingestion pipeline after PV impact triage.
Implement the updated product information by November 5, 2026, ensuring that all labeling and documentation includes the new warnings and risk profiles.
Implement new labeling requirements for choline salicylate products by November 5, 2026, including specific warnings as outlined.
The marketing authorization holder must submit amended product information reflecting the new safety guidelines by October 9, 2026, with translations due by August 10, 2026.
Update labeling to reflect the new indication for Stelara, and ensure compliance with associated regulatory activities including safety monitoring.