Regulatory update on isotretinoin prescribing requirements, a detailed local case safety report documenting posterior reversible encephalopathy syndrome (PRES) in two pediatric oncology patients receiving cyclophosphamide-containing chemotherapy.
New aspect of a known risk (aseptic meningitis in healthy young adults following live attenuated chikungunya vaccination), a new adverse reaction for an established acetylcholinesterase inhibitor (nightmares with galantamine), and a request for supplementary information on the increased risk of ectopic pregnancy with lower-dose levonorgestrel intrauterine devices (13.5 mg).
A label update from the New Zealand regulatory authority (Medsafe) regarding Pisa syndrome associated with donepezil and other medicines. Two local Individual Case Safety Reports (ICSRs) of urinary incontinence following isotretinoin use, with a positive rechallenge in one case.
On March 20, 2026, the U.S. Food and Drug Administration (FDA) issued a significant safety communication requiring the addition of a new warning to all carbidopa/levodopa-containing drug products. These medications, used to treat symptoms of Parkinson's disease, can cause vitamin B6 deficiency and, in some cases, vitamin B6 deficiency-associated seizures.
Drug-induced gynaecomastia, safety updates on empagliflozin and Fournier's gangrene, tolerability of zoledronic acid in elderly patients, emerging concerns with GLP-1 receptor agonists, and recent regulatory changes under the Medicines Amendment Act 2025.
The signals include a new aspect of a known risk (aseptic meningitis with chikungunya vaccine), a rare but serious adverse event (acquired haemophilia with omalizumab), and a routine pharmacovigilance recommendation (pemphigoid with risankizumab).
Presents critical safety information for healthcare professionals, including a label update on drug‑induced aseptic meningitis, a local case report of excessive infant sleep following maternal escitalopram use during breastfeeding, and updates on EPVC educational and awareness initiatives.
Advancing Medication Safety Through Knowledge and Vigilance
