Regulatorische Updates

MHRA notes rare reports of anxiety, low mood, sleep disturbance, poor concentration and forgetfulness in CF patients using Kaftrio, urging clinicians to monitor patients.

The MHRA notes rare cases of intrahepatic cholestasis of pregnancy in patients using azathioprine and other thiopurines, highlighting a class‑wide risk.

The FDA reports that certain bottles may contain mixed strengths of the product, prompting a recall.

FDA recalls Next Advanced Antibacterial Hand Sanitizer due to ethanol below label claim and methanol contamination; related products from the same plant also withdrawn.

The FDA is initiating a recall of all compounded sterile preparations still within their expiration dates because poor sterile production practices have compromised sterility assurance.

Colorado has been cleared by the FDA to pursue its own drug import strategy, though practical implementation may be challenging.

Edwards reports that mislabelled sensor cables on the ForeSight™ Oximeter may cause swapped left/right StO2 values, risking misdiagnosis.

Customer complaints revealed lamina fluid leaks in Beckman Coulter iQ200 and DxU 840m/850m analyzers due to a compromised rinse‑line check valve.

Health Canada warns that certain Aisys™ Carestation™ and Aisys™ CS² anesthesia systems with specific electronic gas mixer assemblies may automatically switch to Alternate O₂ control.

Health Canada permits temporary import and sale of South Korean‑authorized BONKY Calcitriol Injection 1 mcg/mL to mitigate a national shortage, highlighting labeling and pack‑size differences.

MHRA releases new safety and educational resources to support regulatory measures from the 2023 Patient Safety Alert and 2024 Drug Safety Update.

The UK MHRA reports a slight rise in Guillain‑Barré syndrome cases after administration of Pfizer’s Abrysvo and GSK’s Arexvy RSV vaccines in adults aged 60 and older.