Results 201 to 210 of about 455,081 (302)

Zuranolone: A case study in (regulatory) rush to judgement?

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove   +4 more
wiley   +1 more source

Risk of injury associated with the sedative potential of second‐generation antihistamines: A nationwide retrospective cohort study

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Individual second‐generation antihistamines may possess differential sedative potential due to the variability in central histamine receptor H1 occupancy. This study aimed to evaluate whether the sedative potential of second‐generation antihistamines is associated with the risk of injury during Japan's pollen season. Methods We conducted a
Jumpei Taniguchi   +3 more
wiley   +1 more source

HLA genotype testing for carbamazepine, oxcarbazepine and eslicarbazepine: A guideline developed by the UK Centre of Excellence in Regulatory Science and Innovation in Pharmacogenomics (CERSI‐PGx)

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Carbamazepine is licensed in the United Kingdom for the treatment of epilepsy, bipolar disorder and trigeminal neuralgia. The related compounds oxcarbazepine and eslicarbazepine are licensed for the treatment of epilepsy. These drugs can cause immune‐mediated hypersensitivity reactions, which typically affect the skin, and can be of variable severity ...
Lucy Galloway   +24 more
wiley   +1 more source

Identification of major congenital malformations based on healthcare databases in France: A proof‐of‐concept study using the epi‐meres nationwide mother–child register

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Besides registries, healthcare databases can provide useful information for assessing the frequency of major congenital malformations (MCMs) and investigating their risk factors, particularly medication exposures. This study aimed to assess the validity of MCMs identification based on French national, comprehensive healthcare databases ...
Tom Duchemin   +7 more
wiley   +1 more source

Impact of empiric potassium supplementation on mortality, sudden cardiac arrest and stroke in furosemide initiators

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim A prior non‐randomized study suggests that potassium supplementation may improve survival among furosemide initiators, and a randomized trial suggests that salt substitutes containing potassium might lower stroke risk. We conducted a retrospective cohort study using health‐care data to confirm or refute these associations among new users of ...
Thanh Phuong Pham Nguyen   +8 more
wiley   +1 more source

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