- A large meta-analysis of 86 randomized clinical trials with more than 11,000 patients found no significant increased risk for serious adverse events (SAEs) from oral naltrexone vs placebo.
- Certain AEs such as dizziness and vomiting were more common with oral naltrexone, although those data came from only a few studies.
Why this matters
- Concerns exist regarding liver toxicity and other hazards with long-term use.
- Randomized controlled trials on oral naltrexone (>4 weeks) published after January 1, 2001, were identified for this systematic review (86 studies; n=10,957) and meta-analysis (76 studies).
- Funding: No external funding.
- SAEs were analyzed from 31 comparisons (26 studies).
- Naltrexone vs placebo showed no significant increase in the risk for SAEs (risk ratio [RR], 0.84; 95% CI, 0.66-1.06).
- Pooled sensitivity analysis for the number of participants experiencing at least 1 SAE for naltrexone vs placebo was not significant (risk difference, −0.01; 95% CI, −0.02 to 0.00).
- Certain AEs such as dizziness (RR, 1.45; 95% CI, 1.15-1.83) and vomiting (RR, 1.91; 95% CI, 1.51-2.42) were more common with naltrexone vs placebo.
- Findings should be interpreted with caution.
Coauthored with Chitra Ravi, MPharm