Regulatory Safety Updates: Ocrevus, SFDA Signals and Regulator Actions — 9 October 2026

In the daily review of 9 October 2026, PharmExpert assessed new and changed official safety materials. The items below appeared after their individual checkpoints and passed independent QA. The SFDA publications describe potential signals; they do not establish causality on their own.

Ocrevus (ocrelizumab): new drug-induced liver injury warning

AIFA, in agreement with EMA, issued important safety information for Ocrevus. Drug-induced liver injury, including severe and potentially life-threatening cases, has been identified as a new risk. For the intravenous initial regimen, liver-function testing is required before treatment and before the second 300 mg infusion; the CBG-MEB letter specifies one test before the initial 920 mg subcutaneous dose. Symptoms suggestive of liver injury require prompt assessment. Confirmed liver injury requires discontinuation unless a plausible alternative cause is established.

Official sources: ANSM, CBG-MEB DHPC, AIFA NIIS.

SFDA: four potential signals and a quarterly overview

SFDA published potential signals for omalizumab and acquired haemophilia, dabigatran and sepsis, tozinameran and adult-onset Still’s disease, and rivaroxaban and respiratory failure. The SFDA materials present pharmacovigilance data and call for healthcare-professional awareness and reporting of suspected adverse reactions. They do not establish causality.

The SFDA July–September quarterly report lists 120 potential-signal rows awaiting validation, rather than 120 unique drug–event pairs. Its Table 2 presents 146 closed validation outcomes: 25 valid, 4 monitored and 117 refuted. Dabigatran/sepsis and rivaroxaban/respiratory failure overlap with the standalone publications and are not double-counted. The second dabigatran PDF is byte-identical to the first.

Official sources: omalizumab, dabigatran, tozinameran, rivaroxaban, quarterly report.

Recalls and corrective actions

• Roszdravnadzor: the manufacturer is recalling batch 2520825 of IBUPROFEN VELFARM because of a dissolution non-conformity. Official letter 01И-1159/26.
• Medsafe: a replacement hand control is being provided for the Safe Surround Genie Bed because unintended bed movement can create an entrapment, serious-injury and death risk. Official alert.
• Health Canada published actions concerning Avantage Inserter Handles and Grippers, Cardinal Health Presource kits, TruSystem 7000/7500 surgical tables and FreeO2. Scope is limited to the affected cards and listed lots/models. Avantage, Presource, TruSystem, FreeO2.
• ANSM corrected the IPG 3024/3028 identification illustrations in the Inspire MRI manual and issued a preventive stop-use/return action for two JAZZ Endoscope Valve Kit lots. Inspire, JAZZ.

EMA and Ukraine product-information updates

EMA published Mounjaro RMP 10.1, which removes diabetic-retinopathy complications from the important-potential-risk list. This is a safety-specification update and does not state that the medicine has no risks. EMA also published Lucentis product-information changes: retinal vasculitis and retinal occlusive vasculitis were added as adverse reactions with an unknown frequency, based on post-marketing reports.

Ukraine’s Ministry of Health Order No. 1505 implements Rapamune (sirolimus) information changes. The cannabidiol interaction is linked to EPITT No. 19614 and a March 2022 PRAC recommendation; the letermovir interaction is added under a separate PRAC recommendation. This is a national product-information implementation, not a new global signal.

Official sources: Mounjaro, Lucentis, Ukraine MOH Order No. 1505.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications issued by ANSM, CBG-MEB, AIFA, Roszdravnadzor, Medsafe, Health Canada, EMA, SFDA and the Ministry of Health of Ukraine and current as of 9 October 2026. It is not medical or legal advice, does not replace the official source, and does not imply wrongdoing by the manufacturer/marketing authorisation holder or a quality concern affecting the company’s entire product portfolio. Company and product names are used only to identify the official material accurately. Decisions should be based on the primary source, the regulator’s instructions and the approved product information.