Analysis Pharmacovigilance

Nitrofurantoin PSUSA ends in 'maintenance' as PRAC opens two new safety reviews

EMA's nitrofurantoin periodic safety review leaves authorisations unchanged, while the same week's PRAC meeting opened reviews of Deanxit and human immunoglobulins.

VigiEye editorial · Sun 01 Nov 2026

What happened

On 30 October 2026 the EMA published the outcome of the PSUSA, the single assessment of periodic safety update reports, for nitrofurantoin and nitrofurantoin/pyridoxine hydrochloride. The regulatory outcome is 'maintenance'. The EMA also posted a list of the nationally authorised products covered by the procedure.

The records give no detail on the assessment itself. They do not say which safety data were reviewed or whether any product information wording was discussed. Readers should go to the published PSUSA documents for that before drawing conclusions about their own labels.

What 'maintenance' does and does not tell you

A PSUSA brings together periodic safety update reports for active substances that appear in several marketing authorisations, which is common for older, nationally authorised medicines such as nitrofurantoin. The assessment ends with an outcome. 'Maintenance' means the authorisations stay in place as they are on the basis of that assessment.

That is a reassuring result for the benefit-risk balance, but it is not a statement that nothing needs attention. A maintenance outcome closes one review cycle. Signal detection, literature monitoring and case processing carry on, and the next PSUR submission schedule still applies. MAHs should check the EMA's published outcome and product list against their own portfolios rather than assume that no action is needed.

Nitrofurantoin was not alone. On the same day the EMA published maintenance outcomes for gliclazide, tenoxicam and cystine/pyridoxine hydrochloride. Four maintenance outcomes in one publication round is a reminder that most PSUSAs for established substances end without a change in authorisation status.

The contrast: PRAC opens two new reviews

The PSUSA results appeared alongside news from PRAC's October 2026 meeting. According to the EMA and to AIFA, the committee opened a referral on flupentixol/melitracen (Deanxit) and a review of hypersensitivity reports across human normal immunoglobulin medicines. AIFA describes the Deanxit review as concerning serious neurological and psychiatric effects. It describes the immunoglobulin review as concerning hypersensitivity reports linked to batches. The EMA refers to hypersensitivity clusters.

Together with the PSUSA outcomes, these show the two tracks of EU safety work. Scheduled periodic reviews usually confirm established profiles. Signal-driven reviews and referrals begin when a specific concern emerges. The records do not state the outcome, timetable or any interim measures for either new review, so those remain unknown for now.

Beyond the PSUR: reporting and device-linked risks

Two other items in this week's records matter to PV teams. The Paul-Ehrlich-Institut and BfArM are backing the international #MedSafetyWeek campaign, which runs from 2 to 8 November and urges professionals and patients to report suspected side effects so that risks are spotted earlier. Spontaneous reporting is the raw material for signals like those now under review at PRAC, so MAHs with a presence in Germany may see more reports in this period. The records do not predict a volume.

Separately, the FDA flagged its most serious recall classification for four lots of the Werfen HemosIL AcuStar HIT-IgG(PF4-H) assay. The FDA says the lots show negative bias that routine calibration and quality control may miss, and that a supply interruption is expected. This is a device issue, not a drug PSUSA. Heparin-induced thrombocytopenia is an immune-mediated adverse reaction to heparin, so PV and medical safety teams working on heparin products may want to consider how diagnostic availability and accuracy could affect case confirmation and follow-up. The records do not say that any adverse event reports have been affected.

Who is affected and what to watch

MAHs and QPPVs for nitrofurantoin products, including nitrofurantoin/pyridoxine combinations, should review the published outcome and the product list. MAHs for flupentixol/melitracen and for human normal immunoglobulins face the greater near-term workload, because new reviews usually bring requests for data and closer scrutiny of case series.

The EMA has also issued a list of centrally authorised products with safety-related product information changes, dated 30 October 2026. The records do not describe its contents. Centrally authorised MAHs should check whether their products appear and whether labelling actions are due.

Still unknown: the scope and timetable of the Deanxit and immunoglobulin reviews, whether any interim measures will follow, and whether the HemosIL supply interruption will affect HIT testing in practice.

What to do
  • Check the published nitrofurantoin PSUSA outcome and product list against your national authorisations, and file the 'maintenance' result in your PSUR and signal management records.
  • If you hold flupentixol/melitracen or human normal immunoglobulin authorisations, begin preparing case-series and batch-level data for possible PRAC requests.
  • Check whether any of your centrally authorised products appear on the EMA's 30 October 2026 list of safety-related product information changes.
  • Plan for possible extra spontaneous reports during #MedSafetyWeek (2–8 November), and for follow-up on heparin cases if HIT-IgG assay supply is disrupted.

Sources this analysis is based on

Written by VigiEye's editorial system with AI assistance (model claude-sonnet-5-5) strictly from the official records listed above. It can contain errors: check the sources before acting. Not legal, medical or investment advice.

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