Five medicine-safety updates — 21 September 2026

Our review of official regulatory sources identified new and previously omitted updates relevant to pharmacovigilance and medicinal-product safety information management.

EMA concludes review of ipidacrine-containing medicines

On 18 September 2026, EMA announced the conclusion of its review of ipidacrine-containing medicines. CHMP recommended narrowing the indications and removing neuritis, polyneuritis, polyradiculoneuropathy, myasthenic syndrome and demyelinating diseases. An increased risk of adverse reactions at doses above 80 mg/day was confirmed, while possible hepatotoxicity could not be fully excluded.

Official EMA source

EMA review of sodium oxybate for alcohol dependence

EMA published the CHMP opinion on sodium oxybate 175 mg/ml oral syrup for alcohol dependence. The benefit–risk balance remained positive subject to additional efficacy studies. The safety profile was consistent with the known profile, and no new abuse or misuse risks were identified.

Official EMA source

FDA adds warnings to Kybella labeling

On 15 September 2026, FDA announced additional labeling information for Kybella (deoxycholic acid). FDA advises against unapproved injection outside the submental area. The agency identified 129 reports of adverse events associated with such use, including blurred or reduced vision, involuntary eye contractions, muscle and nerve injury, weakness, numbness and difficulty walking. The labeling also addresses persistent injection-site nodules and masses: 117 cases remained unresolved, with a mean duration of 143 days.

Official FDA source

HSA highlights chlorhexidine-associated anaphylaxis

HSA’s September ADR News Bulletin reports that 95 cases of chlorhexidine-associated anaphylaxis had been received as of 1 September 2026, including 23 cases confirmed by allergy testing. Healthcare professionals are advised to consider chlorhexidine as a potentially hidden cause of perioperative and dialysis-related anaphylaxis. The bulletin also discusses aciclovir neurotoxicity in an anuric patient receiving peritoneal dialysis.

Official HSA source

Uzbekistan publishes 27 safety-information updates

Uzbekistan’s Center for Pharmaceutical Products Safety published a package of 27 documents concerning product-information and safety updates. Topics include severe hypertriglyceridaemia with alectinib; suicidal thoughts and behaviour with amantadine; DRESS with amitriptyline; haemophagocytic lymphohistiocytosis, including fatal cases, with glofitamab; non-arteritic anterior ischaemic optic neuropathy with semaglutide; serious consequences of accidental intrathecal and other incorrect administration of tranexamic acid; and the interaction between valproate and clozapine.

Official package from Uzbekistan’s Center for Pharmaceutical Products Safety

Considerations for marketing authorisation holders

Companies should assess whether these developments affect local product information, signal-management procedures, cumulative-data evaluation, risk-minimisation measures and internal safety communication. Any action should be based on the official primary source and applicable national requirements.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications issued by EMA, FDA, HSA and Uzbekistan’s Center for Pharmaceutical Products Safety and current as of 21 September 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by any manufacturer or marketing authorisation holder or a quality concern affecting the entire product portfolio of any company. Company and product names are used only to identify the official materials accurately. Decisions should be based on the primary source, the relevant regulator’s instructions and the approved product information.