Ubrogepant and rimegepant: signal detection using spontaneous reports of adverse events from the Food and Drug Administration Adverse Event Reporting System

References

• Charles JA, Rapoport AM. The American headache society’s position statement on integrating new migraine treatments into clinical practice – comments. Headache United States. 2019;59(4):629–629. doi:10.1111/head.13496.
   Google Scholar
• Dong G, Kjærgaard NA, Shakibfar S, et al. Ubrogepant and rimegepant: systematic review, meta-analysis, and meta-regression of clinical studies. Expert Opin Drug Saf England. 2023;22(1):59–70. doi:10.1080/14740338.2023.2177270.
   PubMed Web of Science ®Google Scholar
• Ailani J, Lipton RB, Hutchinson S, et al. Long-term safety evaluation of ubrogepant for the acute treatment of migraine: phase 3, randomized, 52-week extension trial. Headache Internet. [cited 2023 Apr 27]. 2020;60:141–152. https://pubmed.ncbi.nlm.nih.gov/31913519/
   PubMed Web of Science ®Google Scholar
• Woodhead JL, Siler SQ, Howell BA, et al. Comparing the liver safety profiles of 4 next-generation cgrp receptor antagonists to the hepatotoxic CGRP inhibitor telcagepant using quantitative systems toxicology modeling. Toxicol Sci Internet. [cited 2023 Apr 27] 2022;188(1):108–116. https://pubmed.ncbi.nlm.nih.gov/35556143/
   PubMed Web of Science ®Google Scholar
• Gantenbein AR, Kleinschmidt A. Is the right way to go in between?: rimegepant as needed provides preventive benefit. A comment on: monthly migraine days, tablet utilization, and quality of life associated with rimegepant-post hoc results from an open label safety study (BHV3000-201). J Headache Pain. 2023 [[cited 2023 Apr 27]];24:33. https://pubmed.ncbi.nlm.nih.gov/36997843/
   PubMedGoogle Scholar
• Ruiz M, Cocores A, Tosti A, et al. Alopecia as an emerging adverse event to CGRP monoclonal antibodies: cases Series, evaluation of FAERS, and literature review. Cephalalgia England. 2023;43(2):3331024221143538. doi:10.1177/03331024221143538.
   Web of Science ®Google Scholar
• Gérard AO, Merino D, Van Obberghen EK, et al. Calcitonin gene-related peptide-targeting drugs and Raynaud’s phenomenon: a real-world potential safety signal from the WHO pharmacovigilance database. J Headache Pain England. 2022;23(1):53. doi:10.1186/s10194-022-01424-w
   PubMed Web of Science ®Google Scholar
• Questions FDA Answers on FDA’s adverse event reporting system (FAERS). Accessed; 2018.
   Google Scholar
• Singh J. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. J Pharmacol Pharmacother India. 2015;6:185–187. doi: 10.4103/0976-500X.162004
   PubMed Web of Science ®Google Scholar
• Kass-Hout TA, Xu Z, Mohebbi M, et al. OpenFDA: an innovative platform providing access to a wealth of FDA’s publicly available data. J Am Med Inf Assoc Oxford University Press. 2016;23:596–600. doi:10.1093/jamia/ocv153
   PubMed Web of Science ®Google Scholar
• Sessa M, Andersen M. New insight on the safety of erenumab: an analysis of spontaneous reports of adverse events Recorded in the US food and drug administration adverse event reporting system database. BioDrugs New Zealand. 2021;35(2):215–227. doi:10.1007/s40259-021-00469-8.
   Google Scholar
• Pellesi L, De Icco R, Alawie HY, et al. A systematic review, meta-analysis and meta-regression evaluating the adverse reactions to erenumab in the preventive treatment of migraine. Expert Opin Drug Saf England. 2021;20:467–474. doi:10.1080/14740338.2021.1866537
   PubMed Web of Science ®Google Scholar
• Liang D, Sessa M. Post-marketing safety surveillance of erenumab: new insight from Eudravigilance. Expert Opin Drug Saf England. 2022;21(9):1205–1210. doi:10.1080/14740338.2022.2049231.
   PubMed Web of Science ®Google Scholar
• Sessa M, Kragholm K, Hviid A, et al. Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines. Expert Opin Drug Saf. 2021;20(11):1451–1453. doi:10.1080/14740338.2021.1955101
   PubMed Web of Science ®Google Scholar
• Sidorov G, Velasquez F, Stamatatos E, et al. Syntactic n-grams as machine learning features for natural language processing. Expert Syst Appl Elsevier. 2014;41:853–860. doi: 10.1016/j.eswa.2013.08.015
   Web of Science ®Google Scholar
• Eftekhari S, Salvatore CA, Johansson S, et al. Localization of CGRP, CGRP receptor, PACAP and glutamate in trigeminal ganglion. Relation to the blood-brain barrier. Brain Res Netherlands. 2015;1600:93–109.
   PubMed Web of Science ®Google Scholar
• Lundblad C, Haanes KA, Grände G, et al. Experimental inflammation following dural application of complete Freund’s adjuvant or inflammatory soup does not alter brain and trigeminal microvascular passage. J Headache Pain [Internet] BioMed Central. 2015 [cited 2023 Apr 27];16:1–9. doi:10.1186/s10194-015-0575-8.
   PubMed Web of Science ®Google Scholar
• Kennis M, Gerritsen L, van Dalen M, et al. Prospective biomarkers of major depressive disorder: a systematic review and meta-analysis. Mol Psychiatry England. 2020;25(2):321–338. doi:10.1038/s41380-019-0585-z.
   PubMed Web of Science ®Google Scholar
• Delvecchio G, Altamura AC, Soares JC, et al. Pituitary gland in Bipolar Disorder and Major Depression: evidence from structural MRI studies. J Affect Disord. 2017;218:446–450. doi:10.1016/j.jad.2017.03.066
   PubMed Web of Science ®Google Scholar
• Irimia P, Palma J-A, Idoate MA, et al. Cephalalgia alopecia or nummular headache with trophic changes? A new case with prolonged follow-up. Headache United States. 2013;53:994–997. doi: 10.1111/head.12072
   Google Scholar
• Zou Y, Xu F, Tang Z, et al. Distinct calcitonin gene-related peptide expression pattern in primary afferents contribute to different neuropathic symptoms following chronic constriction or crush injuries to the rat sciatic nerve. Mol Pain United States. 2016;12:1744806916681566.
   Web of Science ®Google Scholar
• Nixdorf DR, Velly AM, Alonso AA. Neurovascular pains: implications of migraine for the oral and maxillofacial surgeon. Oral Maxillofac Surg Clin North Am United States. 2008;20:221–35, vi–vii. doi: 10.1016/j.coms.2007.12.008
   Google Scholar
• Gimeno-Ferrer F, Eitner A, Bauer R, et al. From spreading depolarization to epilepsy with neuroinflammation: the role of CGRP in cortex. Exp Neurol United States. 2022;356:114152. doi:10.1016/j.expneurol.2022.114152
   PubMed Web of Science ®Google Scholar
• Warfvinge K, Edvinsson L. Distribution of CGRP and CGRP receptor components in the rat brain.
   Google Scholar
• Nitecka-Buchta A, Marek B, Baron S. CGRP plasma level changes in patients with temporomandibular disorders treated with occlusal splints—a randomised clinical trial. Endokrynol Pol. 2014;65:217–223. doi: 10.5603/EP.2014.0030
   PubMed Web of Science ®Google Scholar
• Pawlik WW, Obuchowicz R, Biernat J, et al. Role of calcitonin gene related peptide in the modulation of intestinal circulatory, metabolic, and myoelectric activity during ischemia/reperfusion. J Physiol Pharmacol Poland. 2000;51:933–942.
   PubMed Web of Science ®Google Scholar
• Ohno T, Hattori Y, Komine R, et al. Roles of Calcitonin Gene–Related Peptide in Maintenance of Gastric Mucosal Integrity and in Enhancement of Ulcer Healing and Angiogenesis. Gastroenterology United States. 2008;134(1):215–225. doi:10.1053/j.gastro.2007.10.001
   PubMed Web of Science ®Google Scholar
• Larsson O, Olgart L. The enhancement of carbachol-induced salivary secretion by VIP and CGRP in rat parotid gland is mimicked by forskolin. Acta Physiol Scand England. 1989;137(2):231–236. doi:10.1111/j.1748-1716.1989.tb08743.x.
   PubMedGoogle Scholar
• Peskar BM, Wong HC, Walsh JH, et al. A monoclonal antibody to calcitonin gene-related peptide abolishes capsaicin-induced gastroprotection. Eur J Pharmacol Netherlands. 1993;250(1):201–203. doi:10.1016/0014-2999(93)90645-X.
   PubMed Web of Science ®Google Scholar
• Ray JC, Kapoor M, Stark RJ, et al. Calcitonin gene related peptide in migraine: current therapeutics, future implications and potential off-target effects. J Neurol Neurosurg Psychiatry England. 2021;92(12):1325–1334. doi:10.1136/jnnp-2020-324674
   PubMed Web of Science ®Google Scholar
• Sheykhzade M, Amandi N, Pla MV, et al. Binding and functional pharmacological characteristics of gepant-type antagonists in rat brain and mesenteric arteries. Vascul Pharmacol United States. 2017;90:36–43. doi:10.1016/j.vph.2017.02.001
   PubMed Web of Science ®Google Scholar
• Lassen LH, Jacobsen VB, Haderslev PA, et al. Involvement of calcitonin gene-related peptide in migraine: regional cerebral blood flow and blood flow velocity in migraine patients. J Headache Pain England. 2008;9(3):151–157. doi:10.1007/s10194-008-0036-8
   PubMed Web of Science ®Google Scholar
• Holzmann B. Antiinflammatory activities of CGRP modulating innate immune responses in health and disease. Curr Protein Pept Sci Bentham Science Publishers. 2013;14(4):268–274. doi:10.2174/13892037113149990046.
   PubMed Web of Science ®Google Scholar
• Ray JC, Allen P, Bacsi A, et al. Inflammatory complications of CGRP monoclonal antibodies: a case series. J Headache Pain BioMed Central. 2021;22(1):1–8. doi:10.1186/s10194-021-01330-7
   PubMed Web of Science ®Google Scholar
• Joyce CD, Fiscus RR, Wang X, et al. Calcitonin gene-related peptide levels are elevated in patients with sepsis. Surgery United States. 1990;108:1097–1101.
   Google Scholar
• Assas BM, Pennock JI, Miyan JA. Calcitonin gene-related peptide is a key neurotransmitter in the neuro-immune axis. Front Neurosci Switzerland. 2014;8:23. doi: 10.3389/fnins.2014.00023
   PubMed Web of Science ®Google Scholar
• Sohn I, Sheykhzade M, Edvinsson L, et al. The effects of CGRP in vascular tissue - Classical vasodilation, shadowed effects and systemic dilemmas. Eur J Pharmacol Netherlands. 2020;881:173205. doi: 10.1016/j.ejphar.2020.173205
   PubMed Web of Science ®Google Scholar
• Favoni V, Giani L, Al-Hassany L, et al. CGRP and migraine from a cardiovascular point of view: what do we expect from blocking CGRP? J Headache Pain England. 2019;20(1):27. doi:10.1186/s10194-019-0979-y
   PubMed Web of Science ®Google Scholar
• Riera CE. Can Monoclonal Antibodies against CGRP Offer New Treatment Options for Type 2 Diabetes? J Diabetes Clin Res United States. 2020;2:114–118.
   PubMedGoogle Scholar
• Morishita T, Yamaguchi A, Yamatani T, et al. Effects of islet amyloid polypeptide (amylin) and calcitonin gene-related peptide (CGRP) on glucose metabolism in the rat. Diabetes Res Clin Pract Ireland. 1992;15:63–69. doi:10.1016/0168-8227(92)90069-4
   PubMed Web of Science ®Google Scholar
• Rasmussen TN, Bersani M, Schmidt P, et al. Isolation and molecular characterization of porcine calcitonin gene-related peptide (CGRP) and its endocrine effects in the porcine pancreas. Pancreas United States. 1998;16(2):195–204. doi:10.1097/00006676-199803000-00014
   PubMed Web of Science ®Google Scholar
• Seifert H, Sawchenko P, Chesnut J, et al. Receptor for calcitonin gene-related peptide: binding to exocrine pancreas mediates biological actions. Am J Physiol United States. 1985;249(1):G147–51. doi:10.1152/ajpgi.1985.249.1.G147.
   PubMedGoogle Scholar
• Leighton B, Cooper GJ. Pancreatic amylin and calcitonin gene-related peptide cause resistance to insulin in skeletal muscle in vitro. Nature England. 1988;335(6191):632–635. doi:10.1038/335632a0.
   PubMed Web of Science ®Google Scholar
• Mazhar F, Battini V, Gringeri M, et al. The impact of anti-TNFα agents on weight-related changes: new insights from a real-world pharmacovigilance study using the FDA adverse event reporting system (FAERS) database. Expert Opin Biol Ther. [cited 2023 Mar 8] 2021;21:1281–1290. https://pubmed.ncbi.nlm.nih.gov/34191656/
   PubMed Web of Science ®Google Scholar
• Carnovale C, Gentili M, Fortino I, et al. The importance of monitoring adverse drug reactions in elderly patients: the results of a long-term pharmacovigilance programme. Expert Opin Drug Saf [Internet]. 2016 [cited 2023 Mar 8];15:131–139. https://pubmed.ncbi.nlm.nih.gov/26882049/
   PubMed Web of Science ®Google Scholar
• Carnovale C, Gringeri M, Battini V, et al. Beta-blocker-associated hypoglycaemia: new insights from a real-world pharmacovigilance study. Br J Clin Pharmacol 2021 [cited 2023 Mar 8];87:3320–3331. https://pubmed.ncbi.nlm.nih.gov/33506522/
   PubMed Web of Science ®Google Scholar
• Carnovale C, Tombetti E, Battini V, et al. Inflammasome Targeted Therapy in Pregnancy: new Insights from an Analysis of Real-World Data from the FAERS Database and a Systematic Review. Front Pharmacol. 2021 [cited 2023 Mar 8];11. https://pubmed.ncbi.nlm.nih.gov/33551814/
   PubMed Web of Science ®Google Scholar
• Sessa M, Mascolo A, Callréus T, et al. Direct-acting oral anticoagulants (DOACs) in pregnancy: new insight from VigiBase®. Sci Rep. 2019 [cited 2023 Mar 8];9. https://pubmed.ncbi.nlm.nih.gov/31076635/
   Web of Science ®Google Scholar
• Sessa M, Kragholm K, Hviid A, et al. Thromboembolic events in younger women exposed to Pfizer-BioNTech or Moderna COVID-19 vaccines. Expert Opin Drug Saf [Internet]. [cited 2023 Mar 8] 2021;20(11):1451–1453. https://pubmed.ncbi.nlm.nih.gov/34264151/
   PubMed Web of Science ®Google Scholar
• Sessa M, Rossi C, Mascolo A, et al. Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance. Expert Opin Drug Saf [Internet]. [cited 2023 Mar 8]. 2015;14(9):1341–1351. https://pubmed.ncbi.nlm.nih.gov/26156557/
   PubMed Web of Science ®Google Scholar
• Sessa M, Rafaniello C, Sportiello L, et al. Campania Region (Italy) spontaneous reporting system and preventability assessment through a case-by-case approach: a pilot study on psychotropic drugs. Expert Opin Drug Saf. [cited 2023 Mar 8]. 2016;15:9–15. https://pubmed.ncbi.nlm.nih.gov/27875917/
   PubMed Web of Science ®Google Scholar
• Sessa M, Sportiello L, Mascolo A, et al. Campania Preventability Assessment Committee (Italy): a Focus on the Preventability of Non-steroidal Anti-inflammatory Drugs’ Adverse Drug Reactions. Front Pharmacol. 2017;8 [cited 2023 Mar 8]. https://pubmed.ncbi.nlm.nih.gov/28603499/
   Web of Science ®Google Scholar