15 medicine safety updates — 4 September 2026
- 05-09-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
PharmExpert’s review of official regulatory sources identified 15 relevant medicine-safety, pharmacovigilance and risk-management updates.
Highest-priority actions
Carbidopa/levodopa. ANVISA updated Carbidol warnings to address vitamin B6 deficiency, paraesthesia and seizures. Baseline and periodic B6 monitoring is recommended; patients should not stop treatment without medical advice.
Temozolomide. Health Canada announced a Type II retail recall of JAMP Temozolomide 140 mg lot RLTS0225A, DIN 02516829, because the active-ingredient assay was out of specification.
CADD reservoirs with NRFit. Connector-to-tubing leakage may interrupt or delay therapy, cause underdelivery, infectious or toxic exposure, or air embolism. Affected 100 mL and 250 mL lots should be isolated and removed from use.
Aisys/Aisys CS2. Under a specified failure condition, ventilation with 100% oxygen continues but inhaled anaesthetic delivery stops. Facilities should complete pre-operative checks, respond to alarms and use intravenous anaesthesia when needed.
Carestation 850/850c. Following incomplete start-up, loss of AC power may stop gas flow, mechanical and manual ventilation, and anaesthetic delivery. Pending correction, GE HealthCare recommends mains connection, proper one-second start-up and pre-operative checks; unexpected shutdown requires immediate bag ventilation with oxygen and pulse-oximetry assessment.
Official MHRA field safety notices
Risk-management changes
EMA published RMP changes for Pomalidomide Krka and Emtricitabine/Tenofovir disoproxil Mylan. For the latter, pregnancy and lactation in relation to tenofovir were removed from missing information, and the Pregnancy Registry and targeted bone and renal questionnaires were discontinued. Measures addressing HIV acquisition due to poor PrEP adherence and resistance in unrecognised infection remain in place.
EMA’s revised strawberry-leaf monograph retains traditional use for minor urinary complaints and mild diarrhoea in people aged 12 and over. Use is not recommended where fluid intake must be restricted or during pregnancy and breastfeeding because data are insufficient.
Signals and guidance
Published minutes of the June PRAC meeting record seven signals for assessment, including PML with CDK4/6 inhibitors, acquired haemophilia with immune-checkpoint inhibitors, alveolar haemorrhage with osimertinib, and increased lithium exposure with GLP-1 receptor agonists.
WHO completed its 2010–2025 evidence review of vaccines, thiomersal and autism spectrum disorder. The body of evidence does not support a causal association; positive associations came from studies with very low certainty and high risk of bias.
China’s CDE opened consultations on clinical evaluation of higher-valency vaccines and specification changes for marketed traditional Chinese medicines. The drafts emphasise benefit–risk assessment, post-marketing monitoring and avoidance of increased patient-safety risk.
Korea’s KIDS received 73,774 adverse-event reports in Q2 2026 and 143,876 in the first half-year. Spontaneous reports do not by themselves establish causality or incidence.
This summary is based on official regulator publications and does not replace approved product information or local clinical guidance.