PMID- 37612600
OWN - NLM
STAT- MEDLINE
DCOM- 20240308
LR  - 20240308
IS  - 1744-764X (Electronic)
IS  - 1474-0338 (Linking)
VI  - 23
IP  - 3
DP  - 2024 Mar
TI  - Pregnancy-related adverse events associated with statins: a real-world 
      pharmacovigilance study of the FDA Adverse Event Reporting System (FAERS).
PG  - 313-321
LID - 10.1080/14740338.2023.2251888 [doi]
AB  - BACKGROUND: Statins, previously rated as pregnancy category X agents, were 
      contraindicated during pregnancy due to the teratogenic effects observed in 
      animal studies. However, it is still controversial whether statins have 
      detrimental impact on pregnant women or not, and some studies even suggest a 
      potential benefit of statin use against pregnancy complications. The aim of this 
      study was to explore whether maternal exposure to statins is associated with 
      increased rates of pregnancy-related adverse events (AEs), including abortion, 
      abortion spontaneous, preterm birth, low birth weight, stillbirth/fetal death, 
      and fetal complications. RESEARCH DESIGN AND METHODS: Data from 1 January 2004 to 
      30 June 2022 were extracted through the U.S. FDA Adverse Event Reporting System 
      (FAERS) database, to conduct disproportionality analysis and Bayesian analysis by 
      reporting odds ratio (ROR) and Bayesian confidence propagation neural network 
      (BCPNN) algorithms. To identify the potential risks of pregnancy-related AEs, 
      each statin was compared to all the other drugs, all the other statins, and the 
      reference drugs (fenofibrate and evolocumab). RESULTS: A total of 477 cases 
      involving pregnancy-related AEs associated with stains were submitted to the 
      FAERS database by healthcare professionals. No obvious disproportionate 
      association of abortion, abortion spontaneous, or stillbirth/fetal death was 
      identified for all statins during gestation. In comparison with all the other 
      drugs, lovastatin showed an increased risk of fetal complications (ROR = 2.45, 
      95% CI, 1.22-4.95; IC(025) = 0.63), and pravastatin demonstrated increased risks 
      of preterm birth (ROR = 4.89, 95% CI, 3.65-6.54; IC(025) = 1.69) and low birth 
      weight (ROR = 9.60, 95% CI, 5.56-16.56; IC(025) = 1.88). Similar results were 
      found when compared lovastatin or pravastatin with fenofibrate. Furthermore, 
      statins were associated with higher proportion of fetal complications and preterm 
      birth when comparing with evolocumab. CONCLUSIONS: Statins did not increase the 
      risk of pregnancy-related AEs, including abortion, abortion spontaneous, or 
      stillbirth/fetal death. However, we did find significant disproportionality 
      signals for preterm birth and low birth weight associated with pravastatin, and 
      lovastatin was related to a higher proportion of fetal complications. The results 
      in this study may provide evidence on the safety of statins during pregnancy, 
      which need to be verified in further investigations.
FAU - Wu, Tingxi
AU  - Wu T
AD  - Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, 
      Beijing, China.
FAU - Shi, Yanfeng
AU  - Shi Y
AD  - Center of excellence for Omics Research, National Clinical Research Center for 
      Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, 
      Beijing, China.
FAU - Zhu, Bin
AU  - Zhu B
AD  - Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, 
      Beijing, China.
FAU - Li, Dandan
AU  - Li D
AD  - Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, 
      Beijing, China.
FAU - Li, Zhe
AU  - Li Z
AD  - Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, 
      Beijing, China.
FAU - Zhao, Zhigang
AU  - Zhao Z
AD  - Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, 
      Beijing, China.
FAU - Zhang, Yang
AU  - Zhang Y
AD  - Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, 
      Beijing, China.
AD  - Beijing Key Laboratory of Molecular Pharmaceutics and New Drug Delivery Systems, 
      State Key Laboratory of Natural and Biomimetic Drugs, School of Pharmaceutical 
      Sciences, Peking University, Beijing, China.
LA  - eng
PT  - Journal Article
DEP - 20230901
PL  - England
TA  - Expert Opin Drug Saf
JT  - Expert opinion on drug safety
JID - 101163027
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - KXO2KT9N0G (Pravastatin)
RN  - U202363UOS (Fenofibrate)
RN  - 9LHU78OQFD (Lovastatin)
SB  - IM
MH  - Humans
MH  - Infant, Newborn
MH  - Female
MH  - Pregnancy
MH  - United States/epidemiology
MH  - Pharmacovigilance
MH  - *Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects
MH  - Pravastatin
MH  - *Premature Birth/epidemiology
MH  - Stillbirth/epidemiology
MH  - Bayes Theorem
MH  - *Fenofibrate
MH  - Lovastatin
MH  - Adverse Drug Reaction Reporting Systems
MH  - United States Food and Drug Administration
OTO - NOTNLM
OT  - Bayesian analysis
OT  - FAERS
OT  - Pregnancy
OT  - disproportionality analysis
OT  - evolocumab
OT  - fenofibrate
OT  - statins
EDAT- 2023/08/24 00:42
MHDA- 2024/03/08 06:43
CRDT- 2023/08/23 23:36
PHST- 2024/03/08 06:43 [medline]
PHST- 2023/08/24 00:42 [pubmed]
PHST- 2023/08/23 23:36 [entrez]
AID - 10.1080/14740338.2023.2251888 [doi]
PST - ppublish
SO  - Expert Opin Drug Saf. 2024 Mar;23(3):313-321. doi: 10.1080/14740338.2023.2251888. 
      Epub 2023 Sep 1.