Abstract
Background: Tapentadol is a novel atypical opioid. Anecdotal evidence suggests that tapentadol has a lower toxicity than conventional opioids. Objectives: To evaluate all single-drug mortality due to tapentadol and assess serious adverse events caused by tapentadol. Methods: The Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) reporting guidelines, an evidence-based minimum set of items for reporting in systematic reviews, were followed in this systematic review. Results: 24 peer-reviewed papers were identified. They indicate that tapentadol toxicity can cause mortality and serious adverse effects. Conclusion(s): At least four confirmed fatalities, and serious adverse effects have been documented for individuals abusing or using tapentadol as prescribed. Serious adverse effects of tapentadol use may include respiratory depression, confusion, coma, hallucination/delusion, seizures, tachycardia, hypertension, agitation, tremor, miosis, hypotension, dyspnea, electrolyte abnormality, atrial fibrillation or severe upper abdominal pain. Tapentadol is unlikely to cause serotonin syndrome. The toxicity of tapentadol is significantly less than pure mu opioids, such as oxycodone.
Financial & competing interests disclosure
SA Schug is/was a member of the international and the Australian Advisory Board for tapentadol. His employer UWA, but not he personally, has received consulting fees, speaking honoraria and travel grants from the manufacturers of tapentadol, Grunenthal, bioCSL and Seqirus, in the last 5 years. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Systematic review registration number: PROSPERO registration number CRD42017074320