491
Views
0
CrossRef citations to date
0
Altmetric
Systematic Review

Toxicity Of Tapentadol: A Systematic Review

&
Pages 327-339 | Received 07 May 2018, Accepted 22 Jun 2018, Published online: 06 Aug 2018

References

  • Department of Health. Tapentadol, tablet, 50mg, 100mg, 150mg, 200mg and 250mg (as hydrochloride) (sustained release), Palexia SR® – November 2013. The Pharmaceutical Benefits Scheme 2017 (23 August 2013) . www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2013-11/tapentadol. .
  • US FDA Drug Approval Package Tapentadol Hydrochloride Tablets . Application No.: 022304, Approval Date: 12/24/2008 . www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022304s000_TOC.cfm .
  • Emc . Palexia SR prolonged release tablets ( 2018 ). www.medicines.org.uk/emc/product/5158/smpc .
  • Ventura L , CarvalhoF , Dinis-OliveiraRJ . Opioids in the frame of new psychoactive substances network: a complex pharmacological and toxicological issue . Curr. Mol. Pharmacol.04 , 04 ( 2017 ).
  • Tzschentke TM , ChristophT , SchroderWet al. Tapentadol: With two mechanisms of action in one molecule effective against nociceptive and neuropathic pain: Preclinical overview. [German] . Schmerz25 ( 1 ), 19 – 25 ( 2011 ).
  • Knezevic NN , TverdohlebT , KnezevicI , CandidoKD . Unique pharmacology of tapentadol for treating acute and chronic pain . Expert Opin. Drug Metabol. Toxicol.11 ( 9 ), 1475 – 1492 ( 2015 ).
  • Schroder W , VryJD , TzschentkeTM , JahnelU , ChristophT . Differential contribution of opioid and noradrenergic mechanisms of tapentadol in rat models of nociceptive and neuropathic pain . Eur. J. Pain14 ( 8 ), 814 – 821 ( 2010 ).
  • Hartrick CT , RozekRJ . Tapentadol in pain management: a mu-opioid receptor agonist and noradrenaline reuptake inhibitor . CNS Drugs25 ( 5 ), 359 – 370 ( 2011 ).
  • Raffa RB , BuschmannH , ChristophTet al. Mechanistic and functional differentiation of tapentadol and tramadol . Expert Opin. Pharmacother.13 ( 10 ), 1437 – 1449 ( 2012 ).
  • Tzschentke TM , ChristophT , KogelBY . The mu-opioid receptor agonist/noradrenaline reuptake inhibition (MOR-NRI) concept in analgesia: the case of tapentadol . CNS Drugs28 ( 4 ), 319 – 329 ( 2014 ).
  • Lange B , Von ZabernD , EllingC , DuboisC . Efficacy and safety of tapentadol prolonged release for moderate-to-severe chronic osteoarthritis knee pain: a pooled analysis of two double-blind, randomized, placebo- and oxycodone controlled release-controlled studies . Curr. Med. Res. Opin.33 ( 8 ), 1413 – 1422 ( 2017 ).
  • Afilalo M , EtropolskiMS , KuperwasserBet al. Efficacy and safety of tapentadol extended release compared with oxycodone controlled release for the management of moderate to severe chronic pain related to osteoarthritis of the knee: a randomized, double-blind, placebo-and active-controlled Phase III study . Clin. Drug Investig.30 ( 8 ), 489 – 505 ( 2010 ).
  • Baron R , EberhartL , KernKUet al. Tapentadol prolonged release for chronic pain: a review of clinical trials and 5 years of routine clinical practice data . Pain Practice17 ( 5 ), 678 – 700 ( 2017 ).
  • Baron R , LikarR , Martin-MolaEet al. Effectiveness of tapentadol prolonged release (PR) compared with oxycodone/naloxone pr for the management of severe chronic low back pain with a neuropathic component: a randomized, controlled, open-label, Phase 3b/4 study . Pain Pract.16 ( 5 ), 580 – 599 ( 2016 ).
  • Barbosa J , FariaJ , QueirosO , MoreiraR , CarvalhoF , Dinis-OliveiraRJ . Comparative metabolism of tramadol and tapentadol: a toxicological perspective . Drug Metab. Rev.48 ( 4 ), 577 – 592 ( 2016 ).
  • Afilalo M , StegmannJU , UpmalisD . Tapentadol immediate release: a new treatment option for acute pain management . J. Pain Res.3 , 1 – 9 ( 2010 ).
  • Biondi D , XiangJ , BensonC , EtropolskiM , MoskovitzB , RauschkolbC . Tapentadol immediate release versus oxycodone immediate release for treatment of acute low back pain . Pain Phys.16 ( 3 ), E237 – e246 ( 2013 ).
  • Daniels SE , GolfM . Clinical efficacy and safety of tapentadol immediate release in the postoperative setting . J. Am. Podiatr. Med. Assoc.102 ( 2 ), 139 – 148 ( 2012 ).
  • Centres for Disease Control and Prevention . NCHS data on drug-poisoning deaths ( 2017 ). www.cdc.gov/nchs/data/factsheets/factsheet_drug_poisoning.pdf
  • Fox L , HoffmanRS , VlahovD , ManiniAF . Clinical risk factors in Emergency Department (ED) patients with prescription opioid overdose . Clin. Toxicol.53 ( 4 ), 236 ( 2015 ).
  • Moher D , LiberatiA , TetzlaffJ , AltmanDG , ThePG . Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement . PLOS Med.6 ( 7 ), e1000097 ( 2009 ).
  • Baron R , KernU , MullerM , DuboisC , FalkeD , SteigerwaldI . Effectiveness and tolerability of a moderate dose of tapentadol prolonged release for managing severe, chronic low back pain with a neuropathic component: an open-label continuation arm of a randomized Phase 3b study . Pain Pract.15 ( 5 ), 471 – 486 ( 2015 ).
  • Banerjee M , MondalS , SarkarR , MondalH , BhattacharyaK . Comparative study of efficacy and safety of tapentadol versus etoricoxib in mild to moderate grades of chronic osteorthritis of knee . Ind. J. Rheumatol.11 ( 1 ), 21 – 25 ( 2016 ).
  • Buynak R , RappaportSA , RodKet al. Long-term safety and efficacy of tapentadol extended release following up to 2 years of treatment in patients with moderate to severe, chronic pain: results of an open-label extension trial . Clin. Therapeut.37 ( 11 ), 2420 – 2438 ( 2015 ).
  • Buynak R , ShapiroDY , OkamotoAet al. Efficacy and safety of tapentadol extended release for the management of chronic low back pain: Results of a prospective, randomized, double-blind, placebo- and active-controlled Phase III study . Expert Opin. Pharmaco.11 ( 11 ), 1787 – 1804 ( 2010 ).
  • Eichenbaum G , GohlerK , EtropolskiMet al. Does tapentadol affect sex hormone concentrations differently from morphine and oxycodone? An initial assessment and possible implications for opioid-induced androgen deficiency . J. Opioid Manag.11 ( 3 ), 211 – 227 ( 2015 ).
  • Imanaka K , TominagaY , EtropolskiMet al. Efficacy and safety of oral tapentadol extended release in Japanese and Korean patients with moderate to severe, chronic malignant tumor-related pain . Curr. Med. Res. Opin.29 ( 10 ), 1399 – 1409 ( 2013 ).
  • Oh C , RengelshausenJ , MangoldBet al. A thorough QT/QTc study of multiple doses of tapentadol immediate release in healthy subjects . Int. J. Clin. Pharmacol. Ther.48 ( 10 ), 678 – 687 ( 2010 ).
  • Schwartz S , EtropolskiM , ShapiroDYet al. Safety and efficacy of tapentadol ER in patients with painful diabetic peripheral neuropathy: results of a randomized-withdrawal, placebo-controlled trial . Curr. Med. Res. Opin.27 ( 1 ), 151 – 162 ( 2011 ).
  • Steigerwald I , MullerM , KujawaJ , BalblancJ-C , Calvo-AlenJ . Effectiveness and safety of tapentadol prolonged release with tapentadol immediate release on-demand for the management of severe, chronic osteoarthritis-related knee pain: results of an open-label, Phase 3b study (ORIGINAL RESEARCH) . J. Pain Res.5 , 121 ( 2012a ).
  • Steigerwald I , MüllerM , DaviesAet al. Effectiveness and safety of tapentadol prolonged release for severe, chronic low back pain with or without a neuropathic pain component: results of an open-label, Phase 3b study . Curr. Med. Res. Opin.28 ( 6 ), 911 – 936 ( 2012b ).
  • Van Der Schrier R , JonkmanK , Van VelzenMet al. An experimental study comparing the respiratory effects of tapentadol and oxycodone in healthy volunteers . Br. J. Anaesth.119 ( 6 ), 1169 – 1177 ( 2017 ).
  • Wild J , GrondS , KuperwasserBet al. Long-term safety and tolerability of tapentadol extended release for the management of chronic low back pain or osteoarthritis pain . Pain Pract.10 ( 5 ), 416 – 427 ( 2010 ).
  • Vachhani A , BarvaliyaM , NaikV , TripathiCB . Cardiovascular abnormalities with single dose of tapentadol . J. Postgrad. Med.60 ( 2 ), 189 – 191 ( 2014 ).
  • Calvaruso M , SinagraE , CastellucciM , SpadaM , RaimondoD , RizzoAG . Palexia crystals in gastrointestinal tract, a new entity associated with death following gastrointestinal hemorrhage . 67 ( 5–6 ), 373 – 375 ( 2015 ).
  • Walczyk H , LiuCH , AlafrisA , CohenH . Probable tapentadol-associated serotonin syndrome after overdose . Hosp. Pharm.51 ( 4 ), 320 – 327 ( 2016 ).
  • Franco DM , AliZ , LevineB , MiddlebergRA , FowlerDR . Case report of a fatal intoxication by Nucynta . Am. J. Forensic Med. Pathol.35 ( 4 ), 234 – 236 ( 2014 ).
  • Kemp W , SchlueterS , SmalleyE . Death due to apparent intravenous injection of tapentadol . J. Forensic Sci.58 ( 1 ), 288 – 291 ( 2013 ).
  • Cantrell FL , MallettP , AldridgeL , VerilhacK , McintyreIM . A tapentadol related fatality: case report with postmortem concentrations . Forensic Sci. Int.266 , e1 – e3 ( 2016 ).
  • Khaja M , LominadzeG , MillermanK . Cardiac arrest following drug abuse with intravenous tapentadol: case report and literature review . Am. J. Case Rep.18 , 817 – 821 ( 2017 ).
  • Larson SJ , PestanerJ , PrasharSK , BayardC , ZarwellLW , Pierre-LouisM . Postmortem distribution of tapentadol and N-desmethyltapentadol . J. Anal. Toxicol.36 ( 6 ), 440 – 443 ( 2012 ).
  • Tsutaoka BT , HoRY , FungSM , KearneyTE . Comparative toxicity of tapentadol and tramadol utilizing data reported to the national poison data system . Ann. Pharmacother.49 ( 12 ), 1311 – 1316 ( 2015 ).
  • Borys D , StantonM , GumminD , DrottT . Tapentadol toxicity in children . Pediatrics135 ( 2 ), e392 – e396 ( 2015 ).
  • Stollenwerk A , SohnsM , HeisigF , EllingC , Von ZabernD . Review of post-marketing safety data on tapentadol, a centrally acting analgesic . Adv. Therapy35 ( 1 ), 12 – 30 ( 2018 ).
  • Tsutaoka B , HoR , KearneyT . Tapentadol vs tramadol: comparative toxicity utilizing data reported to the national poison data system . Clin. Toxicol.50 ( 7 ), 669 ( 2012 ).
  • Steigerwald I , MullerM , DaviesAet al. Effectiveness and safety of tapentadol prolonged release for severe, chronic low back pain with or without a neuropathic pain component: results of an open-label, phase 3b study . Curr. Med. Res. Opin.28 ( 6 ), 911 – 936 ( 2012 ).
  • Russo M , SantarelliD , IsbisterG . Comment on “probable tapentadol-associated serotonin syndrome after overdose” . Hosp. Pharm.52 ( 4 ), 248 ( 2017 ).
  • Mullins ME , DribbenWH . Comment on tapentadol and serotonin syndrome . Hosp. Pharm.52 ( 4 ), 246 – 247 ( 2017 ).
  • Gressler LE , HammondDA , PainterJT . Serotonin syndrome in tapentadol literature: systematic review of original research . J. Pain Palliat. Care Pharmacother.31 , 228 – 236 ( 2017 ).
  • Tayal G , GrewalA , MittalR , BhatiaN . “Tapentadol” - a novel analgesic . J. Anaesthesiol. Clin. Pharmacol.25 ( 4 ), 463 – 466 ( 2009 ).
  • Guay DR . Is tapentadol an advance on tramadol?Consult. Pharm.24 ( 11 ), 833 – 840 ( 2009 ).
  • Chen A , AshburnMA . Cardiac effects of opioid therapy . Pain Med. (United States)16 , S27 – S31 ( 2015 ).
  • Murphy DL , LebinJA , SevertsonSG , OlsenHA , DasguptaN , DartRC . Comparative rates of mortality and serious adverse effects among commonly prescribed opioid analgesics . Drug Safety1 – 9 ( 2018 ).
  • Raffa RB . On subclasses of opioid analgesics . Curr. Med. Res. Opin.30 ( 12 ), 2579 – 2584 ( 2014 ).
  • Christoph A , EerdekensM-H , KokM , VolkersG , FreynhagenR . Cebranopadol, a novel first-in-class analgesic drug candidate: first experience in patients with chronic low back pain in a randomized clinical trial . Pain158 ( 9 ), 1813 – 1824 ( 2017 ).
  • Häuser W , SchugS , FurlanAD . The opioid epidemic and national guidelines for opioid therapy for chronic noncancer pain: a perspective from different continents . Pain Rep.2 ( 3 ), e599 ( 2017 ).
  • Vosburg SK , SevertsonSG , DartRCet al. Assessment of tapentadol API abuse liability with the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) system . J. Pain19 ( 4 ), 439 – 453 ( 2017 ).

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.