PMID- 32324132
OWN - NLM
STAT- MEDLINE
DCOM- 20200901
LR  - 20200901
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 58
IP  - 6
DP  - 2020 Jun
TI  - PEGylated versus non-PEGylated drugs: A cross-sectional analysis of adverse 
      events in the FDA Adverse Event Reporting System (FAERS) Database
.
PG  - 332-342
LID - 10.5414/CP203735 [doi]
AB  - OBJECTIVE: PEGylation is commonly used to optimize pharmacological properties and 
      improve the clinical response of drugs. Due to the inherent toxicity of 
      polyethylene glycol (PEG) and pharmacological changes induced by PEGylation, the 
      safety may be altered and required to be explored. This study explored the 
      adverse events (AEs) associated with PEGylation by comparing pharmacovigilance 
      data of PEGylated and parent drugs. MATERIALS AND METHODS: We conducted a 
      disproportionality analysis of spontaneous reports associated with PEGylated and 
      corresponding parent medications from the FDA Adverse Event Reporting System 
      database recorded between the 1(st) quarter of 2004 and the 4(th) quarter of 2018 
      at the level of preferred terms (PTs) and standard MedDRA queries (SMQs), 
      respectively. The AEs probably different in risk due to changed pharmacological 
      effects and inherent toxicity of PEG were analyzed. RESULTS: A total of 259,428 
      cases associated to six drug pairs (filgrastim, asparaginase, interferon alpha-2a, 
      interferon alpha-2b,interferon beta-1a, and liposomal doxorubicin) were collected. 
      Although 95% of PTs were comparable between the two groups, PTs of deep vein 
      thrombosis, pancreatitis acute, diabetes mellitus, liver disorder, 
      disorientation, aphasia and infection, and SMQ of embolic and thrombotic events 
      were significantly alleviated by PEGylation. No PT was significantly enhanced by 
      PEGylation. CONCLUSION: The pharmacovigilance profiles of PEGylated and 
      non-PEGylated agents were similar. Further clinical assessment is required to 
      validate the pharmacovigilance data.
FAU - Zhu, Zhengyi
AU  - Zhu Z
FAU - Gao, Peng
AU  - Gao P
FAU - Hu, Yan
AU  - Hu Y
FAU - Wang, Junyan
AU  - Wang J
FAU - Wang, Huijuan
AU  - Wang H
FAU - Yang, Jufei
AU  - Yang J
FAU - Huang, Lingfei
AU  - Huang L
FAU - Ji, Cai
AU  - Ji C
FAU - Ni, Yinghua
AU  - Ni Y
FAU - Fang, Luo
AU  - Fang L
LA  - eng
PT  - Journal Article
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
SB  - IM
MH  - *Adverse Drug Reaction Reporting Systems
MH  - Cross-Sectional Studies
MH  - Databases, Factual
MH  - Humans
MH  - *Pharmacovigilance
MH  - *Polyethylene Glycols
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2020/04/24 06:00
MHDA- 2020/09/02 06:00
CRDT- 2020/04/24 06:00
PHST- 2020/05/14 00:00 [accepted]
PHST- 2020/04/24 06:00 [pubmed]
PHST- 2020/09/02 06:00 [medline]
PHST- 2020/04/24 06:00 [entrez]
AID - 186621 [pii]
AID - 10.5414/CP203735 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2020 Jun;58(6):332-342. doi: 10.5414/CP203735.