title: Fish oil administration in older adults: is there potential for adverse events? A systematic review of the literature.
abstract: BACKGROUND
  Omega-3 (n-3) fatty acid supplementation is becoming increasingly popular. However given its antithrombotic properties the potential for severe adverse events (SAE) such as bleeding has safety implications, particularly in an older adult population. A systematic review of randomized control trials (RCT) was conducted to explore the potential for SAE and non-severe adverse events (non-SAE) associated with n-3 supplementation in older adults.
  
  
  METHODS
  A comprehensive search strategy using Medline and a variety of other electronic sources was conducted. Studies investigating the oral administration of n-3 fish oil containing eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) or both against a placebo were sourced. The primary outcome of interest included reported SAE associated with n-3 supplementation. Chi-square analyses were conducted on the pooled aggregate of AEs.
  
  
  RESULTS
  Of the 398 citations initially retrieved, a total of 10 studies involving 994 older adults aged ≥60 years were included in the review. Daily fish oil doses ranged from 0.03 g to 1.86 g EPA and/or DHA with study durations ranging from 6 to 52 weeks. No SAE were reported and there were no significant differences in the total AE rate between groups (n-3 intervention group: 53/540; 9.8%; placebo group: 28/454; 6.2%; p = 0.07). Non-SAE relating to gastrointestinal (GI) disturbances were the most commonly reported however there was no significant increase in the proportion of GI disturbances reported in participants randomized to the n-3 intervention (n-3 intervention group: 42/540 (7.8%); placebo group: 24/454 (5.3%); p = 0.18).
  
  
  CONCLUSIONS
  The potential for AEs appear mild-moderate at worst and are unlikely to be of clinical significance. The use of n-3 fatty acids and the potential for SAE should however be further researched to investigate whether this evidence is consistent at higher doses and in other populations. These results also highlight that well-documented data outlining the potential for SAE following n-3 supplementation are limited nor adequately reported to draw definitive conclusions concerning the safety associated with n-3 supplementation. A more rigorous and systematic approach for monitoring and recording AE data in clinical settings that involve n-3 supplementation is required.
authors: Anthony M
authors: AM
authors: Villani
authors: Maria
authors: M
authors: Crotty
authors: Leslie G
authors: LG
authors: Cleland
authors: Michael J
authors: MJ
authors: James
authors: Robert J
authors: RJ
authors: Fraser
authors: Lynne
authors: L
authors: Cobiac
authors: Michelle D
authors: MD
authors: Miller
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019587:Dietary Supplements / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage / Q000009:adverse effects; D005395:Fish Oils / Q000008:administration & dosage / Q000009:adverse effects*; D005767:Gastrointestinal Diseases / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic
chemical_list: D015525:Fatty Acids, Omega-3; D005395:Fish Oils
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