A comparison of approaches to identify possible cases of local anesthetic systemic toxicity in the FDA Adverse Event Reporting System (FAERS) database

References

• Zedler B, Xie L, Wang L, et al. Risk factors for serious prescription opioid-related toxicity or overdose among Veterans Health Administration patients. Pain Med. 2014;15:1911–1929.
   PubMed Web of Science ®Google Scholar
• Kessler ER, Shah M, Gruschkus SK, et al. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013;33:383–391.
   PubMed Web of Science ®Google Scholar
• Oderda GM, Evans RS, Lloyd J, et al. Cost of opioid-related adverse drug events in surgical patients. J Pain Symptom Manage. 2003;25:276–283.
   PubMed Web of Science ®Google Scholar
• Oderda GM, Said Q, Evans RS, et al. Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. Ann Pharmacother. 2007;41:400–406.
   PubMed Web of Science ®Google Scholar
• Alam A, Gomes T, Zheng H, et al. Long-term analgesic use after low-risk surgery: a retrospective cohort study. Arch Intern Med. 2012;172:425–430.
   PubMed Web of Science ®Google Scholar
• Brummett CM, Waljee JF, Goesling J, et al. New persistent opioid use after minor and major surgical procedures in US adults. JAMA Surg. 2017;152:e170504.
   PubMed Web of Science ®Google Scholar
• Chou R, Gordon DB, De Leon-Casasola OA, et al. Management of postoperative pain: a clinical practice guideline from the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016;17:131–157.
   PubMed Web of Science ®Google Scholar
• Becker DE, Reed KL. Local anesthetics: review of pharmacological considerations. Anesth Prog. 2012;59:90–102.
   PubMedGoogle Scholar
• Ciechanowicz S, Patil V. Lipid emulsion for local anesthetic systemic toxicity. Anesthesiol Res Pract. 2012;2012:131784.
   PubMedGoogle Scholar
• Neal JM, Bernards CM, Butterworth JF, et al. ASRA practice advisory on local anesthetic systemic toxicity. Reg Anesth Pain Med. 2010;35:152–161.
   PubMed Web of Science ®Google Scholar
• El-Boghdadly K, Chin KJ. Local anesthetic systemic toxicity: continuing professional development. Can J Anaesth. 2016;63:330–349.
   PubMed Web of Science ®Google Scholar
• Mulroy MF. Systemic toxicity and cardiotoxicity from local anesthetics: incidence and preventive measures. Reg Anesth Pain Med. 2002;27:556–561.
   PubMed Web of Science ®Google Scholar
• Gitman M, Barrington MJ. Local anesthetic systemic toxicity: a review of recent case reports and registries. Reg Anesth Pain Med. 2018;43:124–130.
   PubMedGoogle Scholar
• Morwald EE, Zubizarreta N, Cozowicz C, et al. Incidence of local anesthetic systemic toxicity in orthopedic patients receiving peripheral nerve blocks. Reg Anesth Pain Med. 2017;42:442–445.
   PubMed Web of Science ®Google Scholar
• Orebaugh SL, Williams BA, Vallejo M, et al. Adverse outcomes associated with stimulator-based peripheral nerve blocks with versus without ultrasound visualization. Reg Anesth Pain Med. 2009;34:251–255.
   PubMed Web of Science ®Google Scholar
• EXPAREL (bupivacaine liposome injectable suspension). Full prescribing information. San Diego, CA: Pacira Pharmaceuticals, Inc; 2016.
   Google Scholar
• Bergese SD, Ramamoorthy S, Patou G, et al. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107–116.
   PubMedGoogle Scholar
• Aggarwal N. Expert Opin Drug Saf. 2017 Jun 5:1-7. doi: 10.1080/14740338.2017.1335304. [Epub ahead of print]
   Google Scholar
• U.S. Food and Drug Administration. FDA adverse events reporting system (FAERS). [cited 2017 6 8]. Available from: https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/
   Google Scholar
• MedDRA. Medical dictionary for regulatory activities (MedDRA). [cited 2017 12 19]. Available from: https://www.meddra.org/
   Google Scholar
• Di Gregorio G, Neal JM, Rosenquist RW, et al. Clinical presentation of local anesthetic systemic toxicity: a review of published cases, 1979 to 2009. Reg Anesth Pain Med. 2010;35:181–187.
   PubMed Web of Science ®Google Scholar
• Vasques F, Behr AU, Weinberg G, et al. A review of local anesthetic systemic toxicity cases since publication of the American Society of Regional Anesthesia recommendations: to whom it may concern. Reg Anesth Pain Med. 2015;40:698–705.
   PubMed Web of Science ®Google Scholar
• Dickerson DM, Apfelbaum JL. Local anesthetic systemic toxicity. Aesthetic Surg J. 2014;34:1111–1119.
   PubMed Web of Science ®Google Scholar
• Duggirala HJ, Tonning JM, Smith E, et al. Use of data mining at the Food and Drug Administration. J Am Med Inform Assoc. 2016;23:428–434.
   PubMed Web of Science ®Google Scholar
• Evans SJ, Waller PC, Davis S. Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports. Pharmacoepidemiol Drug Saf. 2001;10:483–486.
   PubMed Web of Science ®Google Scholar
• Murff HJ, Patel VL, Hripcsak G, et al. Detecting adverse events for patient safety research: a review of current methodologies. J Biomed Inform. 2003;36:131–143.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. NDA 022496, S009 EXPAREL assessment of efficacy data of studies submitted in support of sNDA. NDA. 2017;022496:S009.
   Google Scholar
• Hoffman KB, Dimbil M, Erdman CB, et al. The Weber effect and the United States Food and Drug Administration’s Adverse Event Reporting System (FAERS): analysis of sixty-two drugs approved from 2006 to 2010. Drug Saf. 2014;37:283–294.
   PubMed Web of Science ®Google Scholar
• Ruetsch YA, Boni T, Borgeat A. From cocaine to ropivacaine: the history of local anesthetic drugs. Curr Top Med Chem. 2001;1:175–182.
   PubMedGoogle Scholar
• Mather LE, Copeland SE, Ladd LA. Acute toxicity of local anesthetics: underlying pharmacokinetic and pharmacodynamic concepts. Reg Anesth Pain Med. 2005;30:553–566.
   PubMed Web of Science ®Google Scholar
• Mather LE. The acute toxicity of local anesthetics. Expert Opin Drug Metab Toxicol. 2010;6:1313–1332.
   PubMed Web of Science ®Google Scholar
• Hu D, Onel E, Singla N, et al. Pharmacokinetic profile of liposome bupivacaine injection following a single administration at the surgical site. Clin Drug Investig. 2013;33:109–115.
   PubMed Web of Science ®Google Scholar
• Bergese SD, Onel E, Morren M, et al. Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile. Reg Anesth Pain Med. 2012;37:145–151.
   PubMed Web of Science ®Google Scholar
• Joshi GP, Patou G, Kharitonov V. The safety of liposome bupivacaine following various routes of administration in animals. J Pain Res. 2015;8:781–789.
   PubMed Web of Science ®Google Scholar
• Rice D, Heil JW, Biernat L. Pharmacokinetic profile and tolerability of liposomal bupivacaine following a repeated dose via local subcutaneous infiltration in healthy volunteers. Clin Drug Investig. 2017;37:249–257.
   PubMed Web of Science ®Google Scholar
• Sites BD, Barrington MJ, Davis M. Using an international clinical registry of regional anesthesia to identify targets for quality improvement. Reg Anesth Pain Med. 2014;39:487–495.
   PubMed Web of Science ®Google Scholar
• Sites BD, Taenzer AH, Herrick MD, et al. Incidence of local anesthetic systemic toxicity and postoperative neurologic symptoms associated with 12,668 ultrasound-guided nerve blocks: an analysis from a prospective clinical registry. Reg Anesth Pain Med. 2012;37:478–482.
   PubMed Web of Science ®Google Scholar
• Barrington MJ, Watts SA, Gledhill SR, et al. Preliminary results of the Australasian Regional Anaesthesia Collaboration: a prospective audit of more than 7000 peripheral nerve and plexus blocks for neurologic and other complications. Reg Anesth Pain Med. 2009;34:534–541.
   PubMed Web of Science ®Google Scholar