References
- Singulair. Highlights of prescribing information. Initial US approval: 1998. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020829s052lbl.pdf [last accessed 17 Sep 2012]
- US Food and Drug Administration. Early Communication about an ongoing safety review of montelukast (Singulair). 2008. Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm070618.htm [last accessed 27 Feb 2013]
- US Food and Drug Administration. Follow-up to the March 27, 2008 communication about the ongoing safety review of montelukast (Singulair). 2009. Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm079523.htm [last accessed 27 Feb 2013]
- US Food and Drug Administration. Updated information on leukotriene inhibitors: montelukast (marketed as Singulair), zafirlukast (marketed as Accolate), and zileuton (marketed as Zyflo and Zyflo CR). 2009. Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm [last accessed 27 Feb 2013]
- FDA. Updated information on leukotriene inhibitors: montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR). 2009. Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm165489.htm [last accessed 27 Feb 2013]
- Manalai P, Woo J, Postolache TT. Suicidality and montelukast. Expert Opin Drug Saf 2009;8:273–282
- Wallerstedt SM, Brunlof G, Sundstrom A, Eriksson AL. Montelukast and psychiatric disorders in children. Pharmacoepidemiol Drug Saf 2009;18:858–864
- Schumock GT, Stayner LT, Valuck RJ, Joo MJ, Gibbons RD, Lee TA. Risk of suicide attempt in asthmatic children and young adults prescribed leukotriene-modifying agents: a nested case-control study. J Allergy Clin Immunol 2012;130:368–375
- Philip G, Hustad C, Noonan G, Malice MP, Ezekowitz A, Reiss TF, Knorr B. Reports of suicidality in clinical trials of montelukast. J Allergy Clin Immunol 2009;124:691–696
- Philip G, Hustad C, Noonan G, Malice MP, Noonan G, Ezekowitz A, Reiss TF, Knorr B. Analysis of behavior-related adverse experiences in clinical trials of montelukast. J Allergy Clin Immunol 2009;124:699–706
- Staffa JA, Dal Pan GJ. Regulatory innovation in postmarketing risk assessment and management. Clin Pharmacol Ther 2012;91:555–557
- Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med 2009;169:1756–1761
- Wagner AK, Soumerai SB, Zhang F, Ross-Degnan D. Segmented regression analysis of interrupted time series studies in medication use research. J Clin Pharm Ther 2002;27:299–309
- Kaplan S, Zhou EH, Iyasu S. Characterization of long-acting beta(2)-adrenergic agonists utilization in asthma patients. J Asthma 2012;49:1079–1085
- Oraka E, King ME, Callahan DB. Asthma and serious psychological distress prevalence and risk factors among US adults, 2001-2007. Chest 2010;137:609–616
- Hurwitz EL, Morgenstern H. Cross-sectional associations of asthma, hay fever, and other allergies with major depression and low-back pain among adults aged 20–39 years in the United States. Am J Epidemiol 1999;150:1107–1116
- Kewalramani A, Bollinger ME, Postolache TT. Asthma and mood disorders. Int J Child Health Hum Dev 2008;1:115–123
- Kuo CJ, Chen VC, Lee WC, Chen WJ, Ferri CP, Stewart R, Lai TJ, et al. Asthma and suicide mortality in young people: a 12-year follow-up study. Am J Psychiatry 2010;167:1092–1099
- Brookhart MA, Sturmer T, Glynn RJ, Rassen J, Schneeweiss S. Confounding control in healthcare database research: challenges and potential approaches. Med Care 2010;48:S114–S120
- Hammad TA, Pinheiro SP, Neyarapally GA. Secondary use of randomized controlled trials to evaluate drug safety: a review of methodological considerations. Clin Trials 2011;8:559–570
- Garbe E, Suissa S. Hormone replacement therapy and acute coronary outcomes: methodological issues between randomized and observational studies. Hum Reprod 2004;19:8–13
- Kaufman DW. Interpretation of associations in pharmacoepidemiology. Semin Hematol 2008;45:181–188
- Kung H-C, Hoyert DL, Xu J, Murphy SL; Division of Vital Statistics. National Vital Statistics Reports. Death: final data for 2005. Available from: http://www.cdc.gov/nchs/data/nvsr/nvsr56/nvsr56_10.pdf [last accessed 17 Sep 2012]