Safety profile of drugs for advanced melanoma: A report based on 2008-2018 US Food and Drug Administration Data.
immunotherapy
melanoma
molecular targeted therapy
pharmacovigilance
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
revised:
13
10
2020
received:
11
06
2020
accepted:
12
11
2020
pubmed:
10
12
2020
medline:
21
9
2021
entrez:
9
12
2020
Statut:
ppublish
Résumé
We describe the safety profiles of all drug classes used for the treatment of advanced melanoma from the US Food and Drug Administration Adverse Event Reporting System over 2008-2018. Adverse reactions reported in 25 900 pharmacovigilance cases are described for chemotherapies, immunomodulators, targeted therapies and immunotherapies. There was a sharp increase in the number of cases over time, with peaks associated with the launch of new treatments. The adverse reactions diversified over time; notably, skin (alopecias, dermatitis) and retinal disorders were frequently associated with targeted therapies and endocrine disorders (hypothalamus, thyroid and adrenal dysfunctions) with immunotherapies. Less well-known reactions were also detected, such as neuropsychiatric disorders with targeted therapies and gastrointestinal ulcers, pneumothorax and pleural effusions with immunotherapies. The findings highlight the need for various health professionals (including medical specialists or trained nurses) to enhance management of complications.
Substances chimiques
Pharmaceutical Preparations
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2988-2995Informations de copyright
© 2020 British Pharmacological Society.
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