Seven medicine safety updates — 17 September 2026

17-09-2026
Posted by: Eldaniz Hasanov
Category: Regulatory Updates

Regulators in Canada, Singapore, Uzbekistan, Russia and France published seven pharmacovigilance and medicine-safety updates identified in PharmExpert’s monitoring on 17 September 2026.

Cabergoline: serious postpartum cardiovascular and neurological risks

Health Canada found a possible link between cabergoline use in postpartum women and serious hypertension, myocardial infarction, stroke and seizures. Canadian product monographs for all cabergoline-containing products will be updated.

Official Health Canada source

Levodopa combinations: vitamin B6 deficiency and seizures

Singapore’s Health Sciences Authority reported overseas post-market cases of vitamin B6 deficiency and seizures associated with carbidopa/levodopa or benserazide/levodopa, including two fatal cases. Local package inserts will be updated, and healthcare professionals may consider assessing vitamin B6 before and during treatment.

Official HSA source

Evrysdi: insoluble particles in prepared solution

Uzbekistan’s Center for Pharmaceutical Product Safety published a notice concerning Evrysdi (risdiplam) 0.75 mg/ml, batches B2033B03 and B2035B09. Insoluble foreign particles were identified in the reconstituted solution.

Official Uzbekistan source

Dekaris/levamisole: leukoencephalopathy and negative benefit-risk

The Uzbekistan regulator also published a DHPC concerning Dekaris 50 mg and 150 mg (levamisole). The communication refers to the European Article 31 review, which concluded that the benefit-risk balance of levamisole-containing medicines for intestinal helminth infections is no longer positive because of the risk of leukoencephalopathy.

Official Uzbekistan source

Rifampicin-Ferein: withdrawal of batch 191123

Roszdravnadzor issued letter No. 01I-1065/26 documenting the withdrawal of Rifampicin-Ferein 150 mg, batch 191123. The decision followed failures involving dissolution time, clarity, particulate matter, related impurities and abnormal toxicity. The letter requires measures to eliminate a threat of harm to life and health.

Official Roszdravnadzor document

RSV prevention: reassuring safety profile but persistent medication errors

France’s ANSM reported that no new safety risks were identified during the 2025–2026 monitoring campaign for Abrysvo, Arexvy, mResvia and Beyfortus (nirsevimab). Medication errors nevertheless continue, including use of the wrong product, incorrect dosing and duplicate administration. Enflonsia (clesrovimab) has been added to the monitoring scope.

Official ANSM source

Easymulti Stress (Men): vitamin B6 labelling recall

Health Canada published a Type III retail recall of Easymulti Stress (Men), NPN 80027572, batches 737, 737A, 737B and 737C. The affected lots are labelled with an incorrect amount of vitamin B6.