Is nicergoline a typical derivative of ergot alkaloids? Comments on the opinion of the European Medicines Agency (EMA) from 2013 on the restriction of the use of medicines containing ergot derivatives Review article
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Published:
Dec 31, 2014
Keywords:
nicergoline, fibrosis, ergotism, EMA
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Abstract
The aim of this commentary is to critically review the opinion issued by European Medicines Agency (EMA) in 2013 on new restrictions on use of medicines containing ergot derivatives. A special emphasis is given to applicability of safety concerns listed in the EMA document to nicergoline.
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References
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3. Saletu B, Garg A, Shoeb A. Safety of nicergoline as an agent for management of cognitive function disorders. Biomed Res Int 2014; 2014:610103. https://doi.org/10.1155/2014/610103.
4. Winblad B, Fioravanti M, Dolezal T et al. Therapeutic use of nicergoline. Clin Drug Investig 2008; 28: 533-52.
5. Hutcheson JD, Setola V, Roth BL, Merryman WD. Serotonin receptors and heart valve disease-it was meant 2B. Pharmacol Ther 2011; 132(2): 146-57.
6. Mirzoyan RS, Ganshina TS, Pukhalskaya TG et al. Effects of nicergoline in experimental models related to pathogenesis of migraine. Methods Find Exp Clin Pharmacol 1989; 11(11): 671-6.
7. Andersohn F, Garbe E. Cardiac and noncardiac fibrotic reactions caused by ergot-and nonergot-derived dopamine agonists. Mov Disord 2009; 24(1): 129-33.
8. Zajdel P, Bednarski M, Sapa J, Nowak G. Ergotamine and nicergolin – facts and myths. Pharmacol Rep 2015; 67(2): 360-363.
9. Shintomi K, Yoshimoto K, Ogawa Y et al. Effects of nicergoline on cerebral energy metabolism in normal mice. Yakugaku Zasshi 1986; 106(1): 90-94.
10. Carfagna N, Rossi A. Nicergoline: biochemical studies on neuronal metabolism. Funct Neurol 1989; 4(4): 177-185.
11. Ayarragaray JE. Ergotism: a change of perspective. Ann Vasc Surg 2014; 28(1): 265-8.
12. Sortino MA, Battaglia A, Pamparana F et al. Neuroprotective effects of nicergoline in immortalized neurons. Eur J Pharmacol 1999; 368(2-3): 285-90.
13. Bolli R, Ware JA, Brandon TA et al. Platelet-mediated thrombosis in stenosed canine coronary arteries: inhibition by nicergoline, a platelet-active alpha-adrenergic antagonist. J Am Coll Cardiol 1984; 3(6): 1417-1426.
14. Elangbam CS, Job LE, Zadrozny LM et al. 5-hydroxytryptamine (5HT)-induced valvulopathy: compositional valvular alterations are associated with 5HT2B receptor and 5HT transporter transcript changes in Sprague-Dawley rats. Exp Toxicol Pathol 2008; 60(4-5): 253-62.
15. Pfitzenmeyer P, Foucher P, Dennewald G et al. Pleuropulmonary changes induced by ergoline drugs. Eur Resp J 1996; 9(5): 1013-19.
16. Tomcsányi J, Vecsey T, Tátrai T. Nicergoline-induced Prinzmetal angina. “Heartache” instead of headache. Orvosi Hetilap 2004; 145(1): 31-32.
17. Kim MJ, Chang JH, Lee SK et al. Acute interstitial nephritis due to nicergoline (Sermion). Nephron 2002; 92(3): 676-9.
2. Fioravanti M, Nakashima T, Xu J, Garg A. A systematic review and meta-analysis assessing adverse event profile and tolerability of nicergoline. BMJ Open 2014; 4(7).
3. Saletu B, Garg A, Shoeb A. Safety of nicergoline as an agent for management of cognitive function disorders. Biomed Res Int 2014; 2014:610103. https://doi.org/10.1155/2014/610103.
4. Winblad B, Fioravanti M, Dolezal T et al. Therapeutic use of nicergoline. Clin Drug Investig 2008; 28: 533-52.
5. Hutcheson JD, Setola V, Roth BL, Merryman WD. Serotonin receptors and heart valve disease-it was meant 2B. Pharmacol Ther 2011; 132(2): 146-57.
6. Mirzoyan RS, Ganshina TS, Pukhalskaya TG et al. Effects of nicergoline in experimental models related to pathogenesis of migraine. Methods Find Exp Clin Pharmacol 1989; 11(11): 671-6.
7. Andersohn F, Garbe E. Cardiac and noncardiac fibrotic reactions caused by ergot-and nonergot-derived dopamine agonists. Mov Disord 2009; 24(1): 129-33.
8. Zajdel P, Bednarski M, Sapa J, Nowak G. Ergotamine and nicergolin – facts and myths. Pharmacol Rep 2015; 67(2): 360-363.
9. Shintomi K, Yoshimoto K, Ogawa Y et al. Effects of nicergoline on cerebral energy metabolism in normal mice. Yakugaku Zasshi 1986; 106(1): 90-94.
10. Carfagna N, Rossi A. Nicergoline: biochemical studies on neuronal metabolism. Funct Neurol 1989; 4(4): 177-185.
11. Ayarragaray JE. Ergotism: a change of perspective. Ann Vasc Surg 2014; 28(1): 265-8.
12. Sortino MA, Battaglia A, Pamparana F et al. Neuroprotective effects of nicergoline in immortalized neurons. Eur J Pharmacol 1999; 368(2-3): 285-90.
13. Bolli R, Ware JA, Brandon TA et al. Platelet-mediated thrombosis in stenosed canine coronary arteries: inhibition by nicergoline, a platelet-active alpha-adrenergic antagonist. J Am Coll Cardiol 1984; 3(6): 1417-1426.
14. Elangbam CS, Job LE, Zadrozny LM et al. 5-hydroxytryptamine (5HT)-induced valvulopathy: compositional valvular alterations are associated with 5HT2B receptor and 5HT transporter transcript changes in Sprague-Dawley rats. Exp Toxicol Pathol 2008; 60(4-5): 253-62.
15. Pfitzenmeyer P, Foucher P, Dennewald G et al. Pleuropulmonary changes induced by ergoline drugs. Eur Resp J 1996; 9(5): 1013-19.
16. Tomcsányi J, Vecsey T, Tátrai T. Nicergoline-induced Prinzmetal angina. “Heartache” instead of headache. Orvosi Hetilap 2004; 145(1): 31-32.
17. Kim MJ, Chang JH, Lee SK et al. Acute interstitial nephritis due to nicergoline (Sermion). Nephron 2002; 92(3): 676-9.