Regulatory Safety Updates: Eliquis, Capoten, Brevital and New Recalls — 12 October 2026

In its daily review of official sources, PharmExpert identified 14 new or changed materials grouped into 13 topics. Only materials that passed primary-source review and independent quality assurance are included. Etcamah is excluded: the exact change to the EMA file will be investigated in the 13 October monitoring cycle and is not presented as a new signal.

Roszdravnadzor: Eliquis and Capoten

Roszdravnadzor published Eliquis (apixaban) educational materials as an additional bleeding-risk minimisation measure. Letter No. 01I-1162/26 and the healthcare-professional guide cover patient information, higher-risk groups, interactions, procedures and treatment interruption, overdose, laboratory tests and suspected adverse-reaction reporting. The material does not announce a new clinical signal or indication change. Official source.

Batch 2340224 of Capoten 25 mg, 20 tablets, is being recalled after a stability-control non-conformity for captopril disulfide. The action is limited to the specified batch. Official letter No. 01I-1161/26.

FDA: two-lot Brevital Sodium recall

Par Health is voluntarily recalling US lots 86930 and 88623 of Brevital Sodium 500 mg/vial (methohexital sodium) because of cellulose particles. The official communication describes potentially serious vascular complications; as of the announcement, the company had not received associated adverse-event reports. Official FDA source.

ANSM: CHIMIO and continuity of duloxetine treatment

ANSM reported a corrective action for CHIMIO Lourd/Web 6.0. When administration is rescheduled, the next day’s time may not be recalculated, creating a risk of shortened intervals or overlapping infusions. The reported cases were intercepted by healthcare professionals and no patient impact was reported. Interim checks are required until the correction is released. Official ANSM source.

During duloxetine 30 mg and 60 mg supply difficulties, ANSM advises limiting new treatment initiation, maintaining continuity for current patients and avoiding abrupt discontinuation. A physician should decide on any substitution. Official ANSM source.

EMA: pharmacovigilance inspections, Giapreza and Pylclari

EMA published the 2025 Pharmacovigilance Inspectors Working Group annual report: 59 human-medicine inspections were conducted. A subset of seven CHMP-requested inspections recorded 88 findings: 0 critical, 35 major and 53 minor. Official EMA report.

The Giapreza (angiotensin II) CRH04 assessment reports early study termination and limited descriptive paediatric data. Efficacy and safety in children remain unestablished; no unexpected signal was identified and no SmPC change was required. Official EMA assessment.

For Pylclari (piflufolastat-18F), SmPC sections 4.4 and 5.1 were updated to allow CE-marked software as an adjunct to visual interpretation for standardised reporting and semiquantitative assessment. The update is not presented as a new adverse-reaction signal. Official EMA page.

TGA: Andrographis and gemcitabine

TGA recorded two Class I consumer recalls covering all unexpired batches of BioCeuticals ArmaForce/Clinical ImmuneForce and Faulding Immune Combat because of continuing reports of anaphylaxis associated with Andrographis. Consumers are instructed to stop use and return the products. BioCeuticals, RC-2026-RN-00743-1; Faulding, RC-2026-RN-00792-1.

A separate Class II hospital recall covers one Gemcitabine 1425 mg in 0.9% NaCl/Freeflex bag, batch BB26096810, after a leak into the inner protective packaging was identified. The official material does not report contamination or patient harm. TGA, RC-2026-RN-00778-1.

NMPA/CDR: iodixanol and a medical-device bulletin

NMPA requires iodixanol product information to be revised following evaluation of post-marketing adverse reactions. The appendix lists reactions of unknown frequency and precautions concerning cardiovascular reactions, contrast encephalopathy, phaeochromocytoma, extravasation and sodium content. Official NMPA Notice No. 96.

CDR also published Medical Device Vigilance Express No. 235/2026-9, consolidating five previously announced international actions involving medical devices and sodium-chloride ampoules. This is one new Chinese review publication, not five new recalls. Official CDR bulletin.

ANVISA: supplements do not replace insulin-resistance treatment

ANVISA warns against abandoning appropriate treatment because of claims made for supplements including berberine, magnesium and myo-inositol. Nutritional correction may be used when advised by a professional, but these supplements are not treatments for insulin resistance. The communication is not a product-specific recall. Official ANVISA source.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications issued by Roszdravnadzor, FDA, ANSM, EMA, TGA, NMPA/CDR and ANVISA and current as of 12 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.