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Prostaglandins Leukot Essent Fatty Acids. 2018 Feb;129:1-12. doi: 10.1016/j.plefa.2018.01.001. Epub 2018 Jan 5.

Safety and tolerability of prescription omega-3 fatty acids: A systematic review and meta-analysis of randomized controlled trials.

Author information

1
Department of Psychiatry, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Department of Food Science, National Pingtung University of Science and Technology, Pingtung, Taiwan.
2
WinShine Clinics in Specialty of Psychiatry, Kaohsiung, Taiwan.
3
Department of Pharmacy, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; Institute of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University, Tainan, Taiwan.
4
Department of Pharmacy, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; School of Pharmacy, College of Pharmacy, Kaohsiung Medical University, Kaohsiung, Taiwan.
5
Department of Psychiatry and Institute for Translational Research in Biomedicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taiwan.
6
Department of Psychological Medicine, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK; College of Medicine, China Medical University (CMU) & Mind-Body Interface Laboratory (MBI-Lab), CMU Hospital, Taichung, Taiwan.
7
Cardiovascular Medical Center, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
8
Department of Food Science, National Pingtung University of Science and Technology, Pingtung, Taiwan.
9
Department of Food Science, National Pingtung University of Science and Technology, Pingtung, Taiwan. Electronic address: globalizationwu@gmail.com.
10
College of Medicine, China Medical University (CMU) & Mind-Body Interface Laboratory (MBI-Lab), CMU Hospital, Taichung, Taiwan. Electronic address: cobolsu@gmail.com.

Abstract

BACKGROUND:

Omega-3 fatty acids [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] are widely recommended for health promotion. Over the last decade, prescription omega-3 fatty acid products (RxOME3FAs) have been approved for medical indications. Nonetheless, there is no comprehensive analysis of safety and tolerability of RxOME3FAs so far.

METHODS:

A systematic review of randomized controlled trials (RCTs) was carried out based on searches in six electronic databases. The studies involving marketed RxOME3FA products were included, and adverse-effect data were extracted for meta-analysis. Subgroup analysis and meta-regression were conducted to explore the sources of potential heterogeneity.

RESULTS:

Among the 21 included RCTs (total 24,460 participants; 12,750 from RxOME3FA treatment cohort and 11,710 from control cohort), there was no definite evidence of any RxOME3FA-emerging serious adverse event. Compared with the control group, RxOME3FAs were associated with more treatment-related dysgeusia (fishy taste; p = 0.011) and skin abnormalities (eruption, itching, exanthema, or eczema; p < 0.001). Besides, RxOME3FAs had mild adverse effects upon some non-lipid laboratory measurements [elevated fasting blood sugar (p = 0.005); elevated alanine transaminase (p = 0.022); elevated blood urea nitrogen (p = 0.047); decreased hemoglobin (p = 0.002); decreased hematocrit (p = 0.009)]. Subgroup analysis revealed that EPA/DHA combination products were associated with more treatment-related gastrointestinal adverse events [eructation (belching; p = 0.010); nausea (p = 0.044)] and low-density lipoprotein cholesterol elevation (p = 0.009; difference in means = 4.106mg/dL).

CONCLUSION:

RxOME3FAs are generally safe and well tolerated but not free of adverse effects. Post-marketing surveillance and observational studies are still necessary to identify long-term adverse effects and to confirm the safety and tolerability profiles of RxOME3FAs.

KEYWORDS:

Adverse effect; Adverse event; Omega-3 fatty acid; Prescription; Safety; Tolerability

PMID:
29482765
DOI:
10.1016/j.plefa.2018.01.001
[Indexed for MEDLINE]

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