Regulatory Safety Updates
Daily updates from official regulatory sources: safety signals, safety communications, restrictions, recalls, risk management plans and labeling changes.
Medicine and device safety updates | 10 November 2026
FDA’s class-wide GLP-1 labelling requirement, a vancomycin lot recall, and Health Canada’s review of myocarditis with entrectinib lead this edition. It also covers device notices and safety reporting guidance. For TGA and Medsafe database entries, the dates shown are action dates. FDA requires a warning on potential NAION risk FDA requires all application holders in
Read the full reviewMedicine and device safety: 20 official communications for 5–6 November 2026
This review covers 20 official medicine, device and pharmacovigilance communications. It distinguishes new risk-management information, new local notices about known issues, and newly published guidance or summaries. Website publication dates are distinguished from underlying document and action dates. Duvyzat (givinostat): interim monitoring advice Following reports of deaths outside the UK in patients with Duchenne muscular
Read the full reviewMedicine and device safety: 25 official communications for 4–5 November 2026
This review covers 25 newly posted or substantively updated official medicine, device and pharmacovigilance communications. Publication dates are distinguished from underlying action dates. New local communications about known issues and an initiated safety review are identified as such. TGA: testing of Synedica peptide products TGA found no detectable labelled TB-500 in tested BPC 157 &
Read the full reviewMedicine and device safety: 14 communications for 3–4 November 2026
This review covers 14 newly posted or updated official safety and pharmacovigilance communications. A local communication about a known issue is distinguished from a new safety signal. The date of a web publication may differ from the date of the underlying action or document. IPIDACRINE VELPHARM: batch 0060626 recall Roszdravnadzor reports a manufacturer recall of
Read the full reviewMedicine and device safety review — 3 November 2026
Ten verified official communications: medicine precautions, selected safety-related recalls, diagnostic-device corrections and pharmacovigilance education. The communications were published on 30 October and 2 November and reviewed on 3 November. Local communications about already known issues are distinguished from new global signals. Mirapex: updated precautions for safe use Roszdravnadzor · Card date: 2026-11-02 · Document: 01И-1276/26;
Read the full reviewMedicine and device safety: 30 October–2 November 2026
Thirteen official communications from seven regulatory sources cover safety reviews, revised warnings, prescribing systems, diagnostic devices and pharmacovigilance education. These communications do not represent thirteen new safety signals. PRAC: Deanxit review and immunoglobulin safety signal EMA · 2026-10-30 EMA reports reviews of persistent neurological/psychiatric reactions with Deanxit and increased hypersensitivity reporting for particular immunoglobulin batches.
Read the full reviewMedicine and device safety updates: 29–30 October 2026
This review brings together 30 official materials from nine regulators: product-information updates, risk-minimisation measures, recalls and medical-device communications. The review period is 29–30 October 2026; source decisions may have earlier dates. The review may be useful to QPPV, LQPPV and LCPPV professionals. The applicability of communications and professional responsibilities should be assessed in the relevant
Read the full reviewMedicine and device safety updates: 27–28 October 2026
This review for 27–28 October 2026 brings together official medicine and device safety materials: product-information changes, risk-minimisation measures, recalls, assessment outcomes and professional materials. Source-document dates are shown separately; the review also includes additional official materials with earlier dates. The review may be useful to QPPV, LQPPV and LCPPV professionals. The applicability of communications and
Read the full reviewMedicine and device safety updates: 26 October 2026
Medicine and device safety updates: 26 October 2026 Twenty topic groups from nine regulators cover recalls, product-information changes, assessment outcomes and pharmacovigilance procedures. This review covers official materials published or changed since the previous review. Publication and underlying decision dates are distinguished; a historical assessment does not establish a new safety signal. For QPPV, LQPPV,
Read the full reviewMedicine and device safety updates: 23 October 2026
Medicine and device safety updates: 23 October 2026 Current as of 23 October 2026 36 official materials in 35 topic groups from 7 regulatory sources. The review covers medicine and device actions, assessment outcomes and pharmacovigilance procedures. Publication and original document dates are identified separately. The review may support QPPV, LQPPV, LCPPV and other pharmacovigilance
Read the full reviewMedicine and device safety updates: 22 October 2026
This review brings together 32 verified materials from nine regulators: warnings, batch actions, risk-management updates and safety-assessment methods. The number of materials is not the number of new clinical safety signals. For QPPV, LQPPV, LCPPV and PV specialists. Professional role names and responsibilities vary by jurisdiction. Disclaimer. This material is provided solely for information and
Read the full reviewMedicine and device safety updates: 21 October 2026
Thirty official sources were reviewed. Fifty-six materials are curated into 34 updates from eight regulators. They cover product information, safety actions, risk-management plans and pharmacovigilance methods. The number of groups is not the number of new signals. This review is for QPPV, LQPPV, LCPPV and PV specialists. Role names and responsibilities vary by jurisdiction. Disclaimer.
Read the full reviewMedicine and device safety updates: 20 October 2026
Official publications are organized into 44 groups covering 58 communications and documents on medicines, devices and safety methodology. Some update known risks or measures; these are not 44 new signals. Preliminary signals, draft guidance and regulatory actions have different status. The review may support QPPV, LQPPV, LCPPV and PV specialists in assessing which official communications
Read the full reviewMedicine and device safety updates: 19 October 2026
Medicine and device safety updates: 19 October 2026 A review of official safety actions, risk minimisation materials and pharmacovigilance publications. A new publication may concern a previously known risk. Relevant to QPPV, LQPPV and LCPPV, recognising that their duties differ between jurisdictions. Roszdravnadzor Romiplostim: Stimplate educational materials support safe preparation and dosing. (Official source; Document
Read the full reviewMedicine and device safety: review as of 16 October 2026
A review of official medicine and device safety communications and pharmacovigilance procedures. A new publication date does not necessarily coincide with the decision date or discovery of a risk. Sources and document dates are identified below. The review may help QPPV, LQPPV and LCPPV assess relevance to their products, local obligations, product information and risk-minimisation
Read the full reviewArgatroban and PEDMARQSI recalls, EMA updates and device safety — 15 October 2026
This digest covers official FDA, TGA, EMA, HPRA, Health Canada and ANVISA communications reviewed as of 15 October 2026. It includes specific-lot recalls, medical-device corrections and updates to medicine information. A newly published document about an earlier decision is not automatically a new clinical safety signal. Medicine recalls: FDA and TGA Argatroban Injection 250 mg/2.5
Read the full reviewPharmacovigilance and regulatory safety updates — 14 October 2026
This monitoring update summarises official safety materials relevant to QPPV, LQPPV and LCPPV functions; titles and responsibilities may differ by jurisdiction. Official safety updates Roszdravnadzor, 13 October: recall of Methylenum blue 1% 25 ml, batch 030226, after a microbiological-purity nonconformity. Official source TGA, 14 October: administering only liquid/diluent without reconstituting the powder component can cause
Read the full reviewIBUPROFEN VELFARM, Pedmarqsi and AYUNA AMA CARE: Safety Measures — 13 October 2026
PharmExpert’s review dated 13 October covers 20 topic groups from official regulator communications and documents. They include batch actions, safety-information changes, additional risk-minimisation measures, device corrective actions and pharmacovigilance operations. Not every publication represents a new clinical signal. Actions concerning specific medicine batches In its letter dated 9 October, Roszdravnadzor reported stopping circulation of IBUPROFEN
Read the full reviewRegulatory 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
Read the full reviewRegulatory Safety Updates: Ocrevus, SFDA Signals and Regulator Actions — 9 October 2026
In the daily review of 9 October 2026, PharmExpert assessed new and changed official safety materials. The items below appeared after their individual checkpoints and passed independent QA. The SFDA publications describe potential signals; they do not establish causality on their own. Ocrevus (ocrelizumab): new drug-induced liver injury warning AIFA, in agreement with EMA, issued
Read the full reviewEight new medicine-safety updates from Russia, Japan, France and Spain
Official communications published on 7–8 October produced eight new packages: two Roszdravnadzor additional risk-minimisation packages for eculizumab and zoledronic acid; circulation termination/recall actions for batches of Bronchorus, ketorolac and simethicone; a PMDA/MHLW reciprocal contraindication for anamorelin and posaconazole; ANSM’s third GLP-1 agonist pharmacovigilance report; and AEMPS’s withdrawal of El Toro containing undeclared sildenafil. QPPVs, LQPPVs
Read the full reviewANSM recalls Ganirelix Theramex batch over impurity — 7 October 2026
France’s medicines regulator ANSM announced a pharmacy- and distribution-level recall of one batch of Ganirelix Theramex after stability studies identified an impurity above the acceptable limit. Products affected Product: Ganirelix Theramex 0.25 mg/0.5 mL solution for injection in a pre-filled syringe, pack of five CIP: 34009 302 381 6 5 Batch: 250208 Expiry: 04/2029 Recall
Read the full reviewHealth Canada nitrosamine recalls and MHRA MOVICOL recall — 6 October 2026
Health Canada published three related Type II recalls of carvedilol 25 mg tablets because N-nitroso-carvedilol may be out of specification. The actions cover 43 lots of Sanis, PMS-Carvedilol and Pro Doc products. Carvedilol recalls: 43 affected lots RA-82722 — Sanis, 13 lots RA-82725 — PMS-Carvedilol, 20 lots RA-82726 — Pro Doc, 10 lots Patients should
Read the full reviewFour medicine safety updates: ciprofloxacin, noradrenaline, thiocolchicoside and undeclared PDE-5 inhibitors
Regulators published four high-importance medicine safety updates on 2 October 2026. Health Canada: ciprofloxacin and SIADH Health Canada found a possible link between systemic ciprofloxacin and syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Five cases were assessed; no deaths were reported. Canadian product monographs for systemic ciprofloxacin products will be updated. Roszdravnadzor: NORADRENALIN AGETAN
Read the full reviewTGA recalls Andrographis medicines over anaphylaxis risk; MHRA flags missing levetiracetam safety information
Two official safety updates published on 1 October 2026 require attention from pharmacovigilance teams. TGA: Class I consumer recall of Andrographis medicines The Therapeutic Goods Administration (TGA) announced Class I consumer recall RC-2026-RN-00747-1 for Nourex Professional Immune Defence 30/60 (batches 194576, 197886, 194828, 198848 and 201158) and Nourex Professional Immune Force 30/60 (batches 147285 and
Read the full reviewFour medicine safety updates from Roszdravnadzor and Swissmedic
On 1 October 2026, PharmExpert identified four new or revised official medicine-safety materials after the previous checkpoint. They may be relevant to QPPV, LQPPV and LPPV professionals assessing local risks, regulatory obligations and risk-minimisation measures. Roszdravnadzor: Epkinly (epcoritamab) Letter No. 02I-1130/26 introduces a patient card addressing cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome
Read the full reviewFour medicine safety updates from MHRA, Ukraine, Medsafe and NMPA
On 30 September 2026, PharmExpert identified four new or revised official medicine-safety materials published after the previous checkpoint. For QPPV, LQPPV and LPPV professionals, these signals may be relevant to local risk assessment, regulatory obligation checks and updates to internal pharmacovigilance procedures. MHRA: September Safety Roundup MHRA covered filters for parenteral nutrition after adverse incidents
Read the full reviewNew medicine safety measures: ibuprofen, fampridine and PMDA updates
Six new substantive pharmacovigilance and medicine-safety materials or regulatory bundles were identified on 29 September 2026. Roszdravnadzor: batch quality actions Ibuprofen Velfarm 400 mg, batch 301025: circulation ceased following a dissolution specification failure (letter 02И-1107/26). Official communication. Ibuprofen Velfarm 200 mg, batches 0530225 and 2690825: circulation ceased following a dissolution specification failure (letter 02И-1108/26). Official
Read the full reviewClozapine blood monitoring revised; insulin and Sarclisa recalls
Swissmedic revised recommendations for clozapine medicines because of the risk of neutropenia and agranulocytosis. Monitoring should use the absolute neutrophil count (ANC); treatment thresholds, monitoring intervals and conditions for rechallenge after mild neutropenia were updated. Health Canada announced a recall of specific Sanofi insulin pens and cartridges that may have frozen during shipping. Reduced insulin
Read the full reviewNew safety measures for Tysabri, macitentan, Remsima and GLP-1 medicines
Roszdravnadzor published four materials. Updated Tysabri materials address PML risk minimisation, JCV stratification and MRI monitoring. A macitentan patient card covers pregnancy prevention, anaemia and liver monitoring. Circulation of Paracetamol 500 mg lot 2210424 and Acetylsalicylic acid 500 mg lot 130824 was terminated for dissolution and assay nonconformity, respectively, with withdrawal and destruction. Swissmedic stated
Read the full reviewMeropenem leaflet errors and IMAAVY glass-particle recall
On 24 September 2026, PharmExpert reviewed two new official medicine-safety communications: an MHRA notification about errors in the patient leaflet for Meropenem 1000 mg and a Health Canada recall of two IMAAVY lots because they may contain glass particles. MHRA: Meropenem 1000 mg, EL(26)A/39 On 23 September, the MHRA issued Class 4 Medicines Defect Notification
Read the full reviewANSM recalls three Flebogamma DIF lots following increased hypersensitivity reports
On 22 September 2026, the French National Agency for the Safety of Medicines and Health Products (ANSM) announced a precautionary recall, agreed with Grifols France, of three lots of the human normal immunoglobulin Flebogamma DIF. Affected lots Flebogamma DIF 50 mg/ml, 400 ml — lot G04L043941, expiry 02/2028; Flebogamma DIF 100 mg/ml, 100 ml —
Read the full reviewFive medicine-safety updates — 22 September 2026
Five new official materials cover two critical US injectable-drug recalls, an Australian regulatory action on Andrographis, and two Ukraine SEC updates. 1. Sodium chloride / concentrated potassium mix-up FDA published a recall of 0.9% Sodium Chloride Injection, USP, 100 ml, lot 1042188: an overwrap may contain Potassium Chloride Injection 10 mEq, lot 1035181. Inadvertent administration
Read the full reviewFive medicine-safety updates — 21 September 2026
New official materials from EMA, FDA, HSA and Uzbekistan’s Center for Pharmaceutical Products Safety covering ipidacrine, sodium oxybate, Kybella, chlorhexidine-associated anaphylaxis and 27 product-information updates.
Read the full reviewFour medicine-safety updates — 18 September 2026
Regulators in Germany, Russia and the Netherlands published four pharmacovigilance and medicine-safety materials identified in PharmExpert’s monitoring on 18 September 2026. Yimmugo: batch recall after serious hypersensitivity reactions Germany’s Paul-Ehrlich-Institut published a Biotest Pharma recall of Yimmugo 100 mg/ml (human normal immunoglobulin), 100 ml, batch C795316P01, expiry 31 August 2028. The recall follows an increased
Read the full reviewSeven medicine safety updates — 17 September 2026
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
Read the full reviewTZIELD: serious viral reactivation risk and new safety measures — 15 September 2026
Health Canada has published important new safety information for TZIELD (teplizumab), used to delay the onset of Stage 3 type 1 diabetes in adults and children aged 8 years and older with Stage 2 disease. Serious and life-threatening cases of viral reactivation have led to new contraindications, screening and monitoring requirements, and permanent-discontinuation criteria. What
Read the full reviewTwo high-priority medicine safety alerts — 14 September 2026
Regulators in the United States and Australia have published two high-priority medicine-safety alerts. The updates concern a nationwide recall of compounded injectable products after elevated bacterial endotoxin results and a counterfeit product sold as retatrutide that caused a serious adverse event. United States: Centric Compounding recalls six injectable lots Centric Compounding is recalling six lots
Read the full reviewTavneos (avacopan) and TGA medicine safety updates — 11 September 2026
Tavneos (avacopan) Swissmedic has issued a Direct Healthcare Professional Communication on Tavneos (avacopan). Major Good Clinical Practice violations invalidate the efficacy results of the ADVOCATE study, while hepatotoxicity concerns further weaken the benefit–risk balance. The marketing authorisation is scheduled for revocation on 30 November 2026; no new patients should be started and current patients should
Read the full reviewThree Important Drug Safety Updates — 10 September 2026
Today’s pharmacovigilance monitoring identified three important updates.
Read the full reviewRoszdravnadzor Stops Circulation of Mesacol Batch JMF1193A — 9 September 2026
Roszdravnadzor has stopped circulation of batch JMF1193A of Mesacol 400 mg, manufactured by Sun Pharmaceutical Industries Ltd (India). The action is based on nonconformity with requirements for mesalazine identity, dosage uniformity, and quantitative determination. The batch owner, Rigla LLC, was instructed to withdraw and destroy the batch. Market participants must take measures to eliminate the
Read the full reviewSeven medicine safety updates — 8 September 2026
The PharmExpert daily review highlights seven significant regulatory updates from Russia, Singapore, Australia and the European Union. 1. Metoprolol retard-Akrikhin: batch recall Roszdravnadzor reported the voluntary recall of batch 1870625 of Metoprolol retard-Akrikhin 50 mg because it failed the dissolution specification. Letter No. 02I-1027/26. Official Roszdravnadzor notice 2. Indapamide: microbiological purity Batch 301025 of Indapamide
Read the full reviewFour Medicine Safety Updates — 7 September 2026
Regulators published four important medicine-safety actions concerning parenteral iron, levamisole, linezolid and epinephrine. The updates include a class-wide European safety review, a market withdrawal, and two quality-related recalls. Parenteral iron: European class-wide safety review EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of all parenteral iron-containing medicines following reports of serious hypophosphataemia, hypophosphataemic
Read the full review15 medicine safety updates — 4 September 2026
PharmExpert’s review of official regulatory sources identified 15 relevant medicine-safety, pharmacovigilance and risk-management updates. Highest-priority actions Carbidopa/levodopa. ANVISA updated Carbidol warnings to address vitamin B6 deficiency, paraesthesia and seizures. Baseline and periodic B6 monitoring is recommended; patients should not stop treatment without medical advice. Official ANVISA alert Temozolomide. Health Canada announced a Type II retail
Read the full reviewFour medicine safety updates — 3 September 2026
Regulators in the United Kingdom, New Zealand, China and Spain have published four clinically important medicine-safety updates. The measures concern filtration during parenteral nutrition, major prescribing and product-information changes, prescription-only control of dextromethorphan–guaifenesin combinations, and the withdrawal of 22 illegal slimming products. United Kingdom: filters required for parenteral nutrition MHRA Device Safety Information DSI/2026/011 advises
Read the full reviewThree medicine safety updates: Aminoselekt, ZOLERIX and Injectafer
2 September 2026 — PharmExpert regulatory safety update Three previously unreported medicine-safety materials were identified during an expanded review of official regulatory sources. Azerbaijan: Aminoselekt batch 2500231 recalled Azerbaijan’s Analytical Expertise Center (AEM) reports a Class 1, Level A recall of Aminoselekt 250 ml intravenous infusion solution, batch 2500231 (expiry 30 September 2026). Visible black
Read the full reviewCorrective medicine safety update: B. Braun, Baxter and Tecfidera
Corrective regulatory safety update — 1 September 2026. This consolidated notice addresses three previously identified materials that had not been presented in full. The EMA PRAC agenda is included separately as an administrative pharmacovigilance note. B. Braun: 0.9% Sodium Chloride Injection recall update The FDA update concerns 0.9% Sodium Chloride Injection USP in 100 mL
Read the full reviewFour medicine safety updates — 1 September 2026
PharmExpert’s review of official pharmacovigilance sources identified one newly published high-priority recall and closed three clinically important regulator updates from the preceding review period. United States: Lipofit Extreme Fat Burner 2.0 recalled nationwide The US Food and Drug Administration published a nationwide consumer-level recall of Lipofit Extreme Fat Burner 2.0, lot 25M12F, expiry 09/2027. Laboratory
Read the full reviewFive medicine safety updates — 28 August 2026
PharmExpert’s daily review of official pharmacovigilance sources identified four new medicine-safety actions and one corrective recall notice. Russia: Vaseline oil batch withdrawn for density non-compliance Roszdravnadzor published Information Letter No. 01I-1009/26 on 27 August 2026 concerning Vaseline oil, oral oil 100 ml, batch 50522, manufactured by Flora Kavkaza JSC. The batch was classified as substandard
Read the full reviewTwo medicine safety updates — 27 August 2026
QTc and torsade de pointes warning for donepezil, plus Baxter’s recall of one anticoagulant sodium citrate solution lot for possible fibreglass particles.
Read the full reviewFive medicine safety updates — 26 August 2026
26 August 2026 — PharmExpert highlights five official medicine safety updates relevant to marketing authorisation holders, pharmacovigilance teams and healthcare professionals. 1. United Kingdom: new advice for finasteride, dutasteride, sotorasib and elranatamab The MHRA updated advice for several medicines. Warnings for finasteride and dutasteride now place greater emphasis on psychiatric adverse effects and sexual dysfunction.
Read the full reviewTwo medicine safety updates — 25 August 2026
25 August 2026 — PharmExpert highlights two official medicine-safety updates relevant to marketing authorisation holders, pharmacovigilance teams and healthcare professionals. 1. Australia: CAROTONE products contain undeclared prescription-only hydroquinone The Therapeutic Goods Administration (TGA) tested three imported, unapproved skin-brightening products: CAROTONE Brightening Oil 65 mL, CAROTONE Clarifying Cream 300 mL and CAROTONE Brightening Body Lotion 350
Read the full reviewThree medicine safety updates — 21 August 2026
21 August 2026 — PharmExpert identified three important updates for marketing authorisation holders, pharmacovigilance professionals and medicine-quality teams. 1. Russia: new GVP/GCP inspection requirements The Government of the Russian Federation adopted Resolution No. 1028 dated 19 August 2026, officially published on 20 August 2026. It adds points 10–48 to Annex 28 of Government Resolution No.
Read the full reviewFive medicine quality recalls and restrictions — 19 August 2026
Roszdravnadzor has published five new notices concerning medicine quality defects. All five cards appeared on 18 August 2026 after the previous pharmacovigilance monitoring checkpoint. The actions affect specific batches of ketorolac, rifampicin, linezolid, troxerutin and calcium gluconate. Key updates 1. Ketorolac, batch 190425 Circulation of Ketorolac 30 mg/mL solution for intravenous and intramuscular injection, manufactured
Read the full reviewNine medicine safety updates — 18 August 2026
On 18 August 2026, PharmExpert identified nine significant medicine-safety materials issued by regulators in Russia, Ukraine, Australia, Canada, Ireland and Japan. Key updates 1. Ipidacrine: benefit–risk review Ukraine’s State Expert Center reported the start of an EMA review of ipidacrine medicines. The assessment concerns efficacy in authorised indications and a potential risk of liver injury.
Read the full reviewFour medicine safety updates — 15 August 2026
On 15 August 2026, PharmExpert identified four high-importance official safety updates: three medicine recalls in Russia for quality defects and one recall in France due to a potential double dose of temozolomide. Ketorolac: recall of batch 170924 PJSC Sintez is recalling batch 170924 of Ketorolac 30 mg/ml solution for intravenous and intramuscular injection because it
Read the full reviewThree Medicine Safety Updates — 14 August 2026
PharmExpert’s daily pharmacovigilance monitoring identified three significant medicine safety updates. Tyenne (tocilizumab-aazg): batch recall due to glass particles The FDA announced a nationwide recall of one batch of Tyenne® (tocilizumab-aazg) injection 400 mg/20 mL: lot 16UI07, expiry 08/2028, NDC 65219-594-20. The recall follows the detection of glass particles in vials. Administration of a particle-containing product
Read the full reviewRoszdravnadzor recalls salicylic-zinc paste batch over pH nonconformity
13 August 2026 — High-importance medicine safety update. Roszdravnadzor has published Information Letter No. 01I-920/26 concerning the withdrawal of a batch of salicylic-zinc paste manufactured by Samaramедпром. Affected medicine Product: Salicylic-Zinc Paste, paste for external use, 25 g Manufacturer: Samaramедпром JSC Batch: 010326 Reason: nonconformity with the established pH specification Regulatory action The manufacturer decided
Read the full reviewTwo Medicine Safety Updates: Meningioma Risk and Falsified DARZALEX — 12 August 2026
PharmExpert’s pharmacovigilance monitoring identified two important medicine-safety topics requiring attention. Desogestrel and etonogestrel: meningioma risk European national regulators have issued direct healthcare professional communications on a small increased risk of meningioma with current prolonged use (one year or longer) of desogestrel- and etonogestrel-containing contraceptives. The estimated excess risk is approximately one additional case per 67,300
Read the full reviewTen Important Medicine Safety Updates — 11 August 2026
PharmExpert presents a review of new official medicine-safety materials identified through regulatory monitoring. Key updates 1. Litfulo (ritlecitinib) European regulators updated recommendations to minimise the risks of major adverse cardiovascular events, malignancy, venous thromboembolism, serious infections and mortality. Particular caution is required in patients aged 65 years or older, patients with cardiovascular or cancer risk
Read the full reviewFive New Medicine Recalls in the United States and Russia — 10 August 2026
On 10 August 2026, regulators in the United States and Russia published information on five medicine recalls with a documented patient-safety connection. United States: three FDA recalls Morphine sulfate: possible substitution with hydromorphone Fresenius Kabi is recalling lot 6402820 of Morphine Sulfate Injection USP, Simplist 2 mg/1 mL. A MicroVault labelled as morphine may contain
Read the full review3 Important Drug Safety Updates — 3 August 2026
PharmExpert LLC Pharmacovigilance Review | 3 August 2026 Our monitoring of official Roszdravnadzor communications identified three updates of practical relevance to marketing authorisation holders and pharmacovigilance, medical information and regulatory professionals. 1. Adalimumab: materials on safe use Roszdravnadzor published information materials on the safe use of medicinal products containing adalimumab. Marketing authorisation holders and responsible
Read the full reviewUzbekistan Pharmaceutical Safety Center: Additional Monitoring of Medicines — 29 July 2026
Medium importance Uzbekistan · Center for Pharmaceutical Product Safety · 29 July 2026 Uzbekistan Pharmaceutical Safety Center: additional monitoring of medicines The Center for Pharmaceutical Product Safety of Uzbekistan published a revised notice prepared in accordance with Chapter 14 of the national standard O‘z MSt 339:2024 “Good Pharmacovigilance Practices (GVP)”. Why this mattersThe notice directly
Read the full review6 Important Drug Safety Updates — 28 July 2026
PharmExpert LLC Pharmacovigilance Review | 28 July 2026 Our daily monitoring of official regulatory sources identified six updates of practical relevance to marketing authorisation holders and pharmacovigilance, quality and regulatory professionals. 1. FDA: Papaverine Hydrochloride Injection recall American Regent is recalling lot 25202 of Papaverine Hydrochloride Injection, USP 60 mg/2 mL due to glass and/or
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