Global PV Safety Digest: September 2026
Published 2026-10-06. Sources: EMA (PRAC, DHPC, PSUSA) | US FDA (Safety Orders, Labeling, DSC) | UK MHRA (Drug Safety Update).
Screening of the September 2026 output of EMA, the US FDA and the UK MHRA identified one PRAC signal leading to a product information update, eight PRAC requests for supplementary data, one FDA Drug Safety Communication, 33 FDA safety-related labeling changes and one MHRA Drug Safety Update. Four signals were prioritised for their operational relevance to MENA marketing authorisation holders and their clinical relevance to prescribers: a new boxed warning for ferric carboxymaltose, DRESS with oxacillin, progressive multifocal leukoencephalopathy with tofacitinib and a new contraindication for paroxetine with QTc-prolonging CYP2D6 substrates.
Ferric carboxymaltose: Symptomatic hypophosphatemia (new boxed warning)
US FDA. Boxed warning added; warnings and precautions and patient information revised. Generic application holders are expected to update their labeling. Reference: FDA Drug Safety Communication, 1 September 2026; Safety-related labeling change, Injectafer NDA 203565 SUPPL-30 (13 August 2026).
FDA Drug Safety Communication FDA SrLC database: Injectafer
Oxacillin: Drug reaction with eosinophilia and systemic symptoms (DRESS)
EMA – PRAC. Product information amendment (SmPC 4.4 and 4.8, package leaflet sections 2 and 4). Variation to be submitted within 2 months of publication of the PRAC recommendation. Reference: PRAC recommendations on signals adopted at the 31 August–3 September 2026 meeting (EMA/PRAC/183502/2026), EPITT no 20223, published 28 September 2026.
PRAC recommendations on signals (PDF) New product information wording (PDF)
Tofacitinib: Progressive multifocal leukoencephalopathy (PML)
US FDA. Warnings and precautions (5.1 Serious Infections), postmarketing adverse reactions, Medication Guide and patient counselling information updated. Reference: Safety-related labeling change, Xeljanz/Xeljanz XR NDA 203214 SUPPL-42, approved 16 September 2026.
Paroxetine: QTc prolongation with CYP2D6 substrates (new contraindication)
US FDA. New contraindication; warnings and precautions, drug interaction table, use in specific populations and Medication Guide extensively revised. Reference: Safety-related labeling changes, Paxil NDA 020031 SUPPL-81 and NDA 020710 SUPPL-49, Paxil CR NDA 020936 SUPPL-62, approved 23 September 2026.
What this means for MENA marketing authorisation holders
Safety decisions by EMA, FDA and MHRA usually reach MENA markets indirectly. Authorities such as SFDA, EDA, MOHAP and JFDA expect MAHs to keep local product information aligned with current scientific knowledge and often ask for variations once a reference agency has acted. For local MAHs, each external signal therefore starts a chain of work: a documented signal assessment in the signal management system, a product information gap analysis and change control, a safety variation with an Arabic leaflet translation, and inclusion in the next PSUR/PBRER and, where relevant, the RMP. Inspectors increasingly check that this chain is traceable, from the date the external signal was published to the date the local label was updated. A dated screening log, a single signal tracker and PSUR/PBRER calendars that reflect new risks keep the PV system audit-ready, and they show that decisions from Amsterdam, Silver Spring and London are acted on consistently across every MENA registration.