1. Respreeza DHPC: vial closure defects risk missed doses and infection
A direct healthcare professional communication on Respreeza (human alpha1-proteinase inhibitor) was disseminated on 4 November in the EU and in Switzerland. In the reported cases, parts of the vial closure loosened or came off when the Mix2Vial transfer set was removed after reconstitution, even when the product was prepared as instructed; this can prevent administration and, if the vial is no longer sealed, carries a risk of microbial contamination and serious infection. As of 30 September the company had 13 confirmed complaints traced to one filling lot, and its review of the global safety database found no adverse events linked to the defect; in Switzerland the affected batch is P100907953. Defective vials must not be used, and patients treated at home should be told to watch for signs of infection such as fever and chills. For safety teams, the communication is a reminder that quality defects in home-administered products need product complaint and adverse event processes that talk to each other. EMA DHPC, 4 Nov 2026 · Swissmedic DHPC, 4 Nov 2026
2. Swissmedic puts mandated risk-minimisation material on one central platform
Since 1 November, officially mandated information material in Switzerland, such as prescriber guides, checklists, patient brochures and patient cards, is available electronically in one place: www.swissmedicinfo-pro.ch for healthcare professionals and www.swissmedicinfo.ch for patients. Users can search by product or active substance and download the material directly, with contact details of the marketing authorisation holder for ordering printed copies. Swissmedic announced the change on 3 November and presents it as a way to support the use of risk minimisation measures in daily practice. Marketing authorisation holders with additional risk minimisation measures in Switzerland should check that their current, approved versions are the ones published on the platform. Swissmedic information, 3 Nov 2026
3. Medsafe warns on unapproved peptide products, mostly sold as retatrutide
New Zealand's regulator Medsafe updated its warning on unapproved peptide products on 4 November, stressing that their contents, quality, sterility and dosing are unknown and that importing or supplying them without a prescriber's approval is illegal. As of 21 October, the New Zealand pharmacovigilance database held 10 reports for unapproved peptides, mostly from women who believed they were taking retatrutide, which is not approved by any trusted regulator. Five reports involved hospitalisation or came from a hospital; most described gastrointestinal symptoms, and half mentioned possible cardiac effects such as chest pain, palpitations or hypertension. Medsafe also cautions that laboratory test results promoted by sellers do not make a product safe. Grey-market use of investigational incretin drugs is now a recurring source of case reports, and companies developing these molecules should expect reports in which the product actually used cannot be verified. Medsafe alert, 4 Nov 2026
4. Health Canada: leaking sodium citrate anticoagulant bags kept on the market with checks
Health Canada published a health professional risk communication on 3 November about potential leaks in certain lots of Fresenius Kabi's Anticoagulant Sodium Citrate Solution USP 4 g/100 mL, used with apheresis devices. Manufacturing-related defects such as sealing and lamination issues can cause loss of anticoagulant, interrupted procedures or microbial contamination. The affected lots are not being recalled, because leaks can be detected before use and a recall could significantly disrupt plasma collection; instead, every bag, regardless of lot, must be inspected by squeezing the inner bag and discarded if it leaks or the solution is not clear. The company reports no adverse events or contamination complaints so far. Health Canada risk communication, 3 Nov 2026
5. Liver injury from antihypertensives is rare but linked to HLA-B*35:01
A study in Acta Pharmaceutica Sinica B, publicised on 4 November, analysed 2,207 high-confidence drug-induced liver injury cases from the US Drug-Induced Liver Injury Network (2003–2024) and attributed 44 (2%) to antihypertensives, including ACE inhibitors or ARBs (14), methyldopa (13) and hydralazine (11); two patients needed liver transplantation. HLA-B*35:01 was carried by half of the antihypertensive cases, against 11% of cases due to other drugs (odds ratio 6.0), with the strongest association for methyldopa, and carriers developed injury sooner (median onset 50 versus 109 days). The authors note that the small number of cases limits the conclusions. For signal assessment, the finding adds to the evidence that HLA-B*35:01 is a susceptibility marker for immune-mediated liver injury across several drug classes. Dara et al., Acta Pharmaceutica Sinica B, reported 4 Nov 2026
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