Can intranasal corticosteroids cause migraine-like headache?
J Pokladnikova
Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University in Prague, Hradec Kralove, The Czech Republic,
Search for more papers by this authorRHB Meyboom
WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, Uppsala, Sweden, and
Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht University, Utrecht, the Netherlands
Search for more papers by this authorJ Vlcek
Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University in Prague, Hradec Kralove, The Czech Republic,
Search for more papers by this authorRI Edwards
WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, Uppsala, Sweden, and
Search for more papers by this authorJ Pokladnikova
Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University in Prague, Hradec Kralove, The Czech Republic,
Search for more papers by this authorRHB Meyboom
WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, Uppsala, Sweden, and
Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht University, Utrecht, the Netherlands
Search for more papers by this authorJ Vlcek
Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University in Prague, Hradec Kralove, The Czech Republic,
Search for more papers by this authorRI Edwards
WHO Collaborating Centre for International Drug Monitoring, Uppsala Monitoring Centre, Uppsala, Sweden, and
Search for more papers by this authorAbstract
Intranasal corticosteroids (INCs) act predominantly locally and are considered to exert minimal systemic effects. On reviewing the international data collected in the World Health Organization's global pharmacovigilance programme an unexpected cluster was found of 38 case reports of migraine in suspected connection with INCs. These reports came from five countries (May 2007) and concerned six different drugs. In all reports the INC was the sole suspect drug. In nine cases re-exposure to the drug had taken place, leading to the recurrence of the event in eight of these patients. However, INCs are mainly used for rhinitis, and there is a known connection between rhinitis and migraine. Although representing only 0.6% of the total of case reports, international pharmacovigilance data suggest that the use of INCs may cause or trigger migraine or migraine-like headache. Further study is needed to determine if the reported association is true or not and, if so, what the possible mechanism is.
References
- 1 Passalacqua G, Albano M, Canonica GW, Bachert C, Van Cauwenberge P, Davies RJ et al. Inhaled and nasal corticosteroids: safety aspects. Allergy 2000; 55: 16–33.
- 2 Salib RJ, Howarth PH. Safety and tolerability profiles of intranasal antihistamines and intranasal corticosteroids in the treatment of allergic rhinitis. Drug Saf 2003; 26: 863–93.
- 3 Baena-Cagnani CE. Safety and tolerability of treatments for allergic rhinitis in children. Drug Saf 2004; 27: 883–98.
- 4 Cave A, Arlett P, Lee E. Inhaled and nasal corticosteroids: factors affecting the risks of systemic adverse effects. Pharmacol Ther 1999; 83: 153–79.
- 5 U.S. Food and Drug Administration (FDA) RHINOCORT AQUA (budesonide). Home Page. 2006. [WWW document]. URL http://www.fda.gov/medwatch/SAFETY/2003/03SEP_PI/Rhinocort_PI.pdf
- 6 U.S. Food and Drug Administration (FDA) BECONASE AQ (beclomethasone dipropionate, monohydrate). Home Page. 2006. [WWW document]. URL http://www.fda.gov/medwatch/SAFETY/2005/Oct_PI/BeconaseAQ_PI.pdf
- 7 U.S. Food and Drug Administration (FDA) NASONEX (mometasone furoate monohydrate). Home Page. 2006. [WWW document]. URL http://www.fda.gov/cder/foi/label/2000/20762S9lbl.pdf
- 8 Pokladnikova J, Meyboom RH, Vlcek J, Edwards IR. Can intranasally administered corticosteroids cause neuropsychiatric disturbances? A review of the International Pharmacovigilance Programme of the World Health Organisation. Ann Allergy Asthma Immunol 2008; 101: 67–73.
- 9 Trangsrud AJ, Whitaker AL, Small RE. Intranasal corticosteroids for allergic rhinitis. Pharmacotherapy 2002; 22: 1458–67.
- 10 Olsson S. The role of the WHO programme on International Drug Monitoring in coordinating worldwide drug safety efforts. Drug Saf 1998; 19: 1–10.
- 11 Edwards IR, Biriell C. Harmonisation in pharmacovigilance. Drug Saf 2000; 23: 95–9.
- 12 The Uppsala Monitoring Centre. WHO adverse reaction terminology. Uppsala: The Uppsala Monitoring Centre 2004.
- 13 The Uppsala Monitoring Centre. WHO drug dictionary 2nd quarter. Uppsala: The Uppsala Monitoring Centre 2006.
- 14 Sean C.Sweetman. Martindale, the extra pharmacopoeia. London: London Pharmaceutical Press 2004.
- 15 Weber R, Garcia J, Faruqi R, Banerji D, Georges G; 405 Investigator Group. Safety and clinical relief over 1 year with triamcinolone acetonide hydrofluoroalkane-134a nasal aerosol in patients with perennial allergic rhinitis. Allergy Asthma Proc 2006; 27: 243–7.
- 16 Gawchik SM, Saccar CL. A risk–benefit assessment of intranasal triamcinolone acetonide in allergic rhinitis. Drug Saf 2000; 23: 309–22.
- 17 Onrust SV, Lamb HM. Mometasone furoate. A review of its intranasal use in allergic rhinitis. Drugs 1998; 56: 725–45.
- 18 Brannan MD, Herron JM, Affrime MB. Safety and tolerability of once-daily mometasone furoate aqueous nasal spray in children. Clin Ther 1997; 19: 1330–9.
- 19 Lundblad L, Sipila P, Farstad T, Drozdziewicz D. Mometasone furoate nasal spray in the treatment of perennial non-allergic rhinitis: a nordic, multicenter, randomized, double-blind, placebo-controlled study. Acta Otolaryngol 2001; 121: 505–9.
- 20 Bryson HM, Faulds D. Intranasal fluticasone propionate. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in allergic rhinitis. Drugs 1992; 43: 760–75.
- 21 Holm AF, Fokkens WJ, Godthelp T, Mulder PG, Vroom TM, Rijntjes E. A 1-year placebo-controlled study of intranasal fluticasone propionate aqueous nasal spray in patients with perennial allergic rhinitis: a safety and biopsy study. Clin Otolaryngol 1998; 23: 69–73.
- 22 Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache 2001; 41: 646–57.
- 23 Ku M, Silverman B, Prifti N, Ying W, Persaud Y, Schneider A. Prevalence of migraine headaches in patients with allergic rhinitis. Ann Allergy Asthma Immunol 2006; 97: 226–30.
- 24 Aamodt AH, Stovner LJ, Langhammer A, Hagen K, Zwart JA. Is headache related to asthma, hay fever, and chronic bronchitis? The Head-HUNT Study. Headache 2007; 47: 204–12.
- 25 Kemper RH, Meijler WJ, Korf J, Ter Horst GJ. Migraine and function of the immune system: a meta-analysis of clinical literature published between 1966 and 1999. Arch Intern Med 2005; 165: 954.
- 26 Illum L. Transport of drugs from the nasal cavity to the central nervous system. Eur J Pharm Sci 2000; 11: 1–18.
- 27 Talegaonkar S, Mishra PR. Intranasal delivery: an approach to bypass the blood brain barrier. Indian J Pharmacol 2004; 36: 140–7.
- 28 Boscaro M, Sonino N, Scarda A, Barzon L, Fallo F, Sartori MT et al. Anticoagulant prophylaxis markedly reduces thromboembolic complications in Cushing's syndrome. J Clin Endocrinol Metab 2002; 87: 3662–6.
- 29 Casonato A, Pontata E, Boscaro M, Sonino N, Sartorello F, Ferasin S et al. Abnormalities of von Willebrand factor are also part of the prothrombotic state of Cushing's syndrome. Blood Coagul Fibrinolysis 1999; 10: 145–51.
- 30 Slooter AJ, Ramos LM, Kappelle LJ. Migraine-like headache as the presenting symptom of cerebral venous sinus thrombosis. J Neurol 2002; 249: 775–6.
- 31 Schreiber CP, Hutchinson S, Webster CJ, Ames M, Richardson MS, Powers C. Prevalence of migraine in patients with a history of self-reported or physician-diagnosed ‘sinus’ headache. Arch Intern Med 2004; 164: 1769–72.