期刊论文详细信息
BMC Clinical Pharmacology
Reporting of drug induced depression and fatal and non-fatal suicidal behaviour in the UK from 1998 to 2011
David Gunnell2  Munir Pirmohamed4  John Potokar1  Richard M Martin2  Kyla H Thomas3 
[1]The Academic Unit of Psychiatry, University of Bristol Bristol, UK
[2]School of Social and Community Medicine, University of Bristol, Canynge Hall 39 Whatley Road, Bristol BS8 2PS, UK
[3]Health and Wellbeing Division, Department for Children, Adults and Health, South Gloucestershire Council Badminton Road, Yate, Bristol, UK
[4]Centre for Drug Safety Science, University of Liverpool Liverpool, UK
关键词: Adverse effects;    Yellow card;    Depression;    Self injury;    Non-fatal suicidal behaviour;    Suicide;    Adverse drug reaction;   
Others  :  1084717
DOI  :  10.1186/2050-6511-15-54
 received in 2014-03-23, accepted in 2014-09-23,  发布年份 2014
PDF
【 摘 要 】

Background

Psychiatric adverse drug reactions (ADRs) are distressing for patients and have important public health implications. We identified the drugs with the most frequent spontaneous reports of depression, and fatal and non-fatal suicidal behaviour to the UK’s Yellow Card Scheme from 1998 to 2011.

Methods

We obtained Yellow Card data from the Medicines and Healthcare products Regulatory Agency for the drugs with the most frequent spontaneous reports of depression and suicidal behaviour from 1964 onwards. Prescribing data were obtained from the NHS Information Centre and the Department of Health. We examined the frequency of reports for drugs and estimated rates of reporting of psychiatric ADRs using prescribing data as proxy denominators from 1998 to 2011, as prescribing data were not available prior to 1998.

Results

There were 110 different drugs with ≥ 20 reports of depression, 58 with ≥10 reports of non-fatal suicidal behaviour and 33 with ≥5 reports of fatal suicidal behaviour in the time period. The top five drugs with the most frequent reports of depression were the smoking cessation medicines varenicline and bupropion, followed by paroxetine (a selective serotonin reuptake inhibitor), isotretinoin (used in acne treatment) and rimonabant (a weight loss drug). Selective serotonin reuptake inhibitors, varenicline and the antipsychotic medicine clozapine were included in the top five medicines with the most frequent reports of fatal and non-fatal suicidal behaviour. Medicines with the highest reliably measured reporting rates of psychiatric ADRs per million prescriptions dispensed in the community included rimonabant, isotretinoin, mefloquine (an antimalarial), varenicline and bupropion. Robust denominators for community prescribing were not available for two drugs with five or more suicide reports, efavirenz (an antiretroviral medicine) and clozapine.

Conclusions

Depression and suicide-related ADRs are reported for many nervous system and non-nervous system drugs. As spontaneous reports cannot be used to determine causality between the drug and the ADR, psychiatric ADRs which can cause significant public alarm should be specifically assessed and reported in all randomised controlled trials.

【 授权许可】

   
2014 Thomas et al.; licensee BioMed Central Ltd.

【 预 览 】
附件列表
Files Size Format View
20150113163810137.pdf 852KB PDF download
Figure 2. 60KB Image download
Figure 1. 36KB Image download
【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】
  • [1]Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, Farrar K, Park BK, Breckenridge AM: Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004, 329:15-19.
  • [2]European Medicines Agency: The European Medicines Agency recommends suspension of the marketing authorisation of Acomplia. London, UK: European Medicines Agency; 2008.
  • [3]Kuehn BM: Studies linking smoking-cessation drug with suicide risk spark concerns. JAMA 2009, 301:1007-1008.
  • [4]BBC Panorama: The Secrets of Seroxat. 2002. http://news.bbc.co.uk/panorama/hi/front_page/newsid_8425000/8425414.stm webcite
  • [5]BBC Three: Dying for clear skin. 2012. http://www.bbc.co.uk/programmes/p00xxy87 webcite
  • [6]Waller PC, Wood SM, Langman MJS, Breckenridge AM, Rawlins MD: Review Of Company Postmarketing Surveillance Studies. BMJ 1992, 304:1470-1472.
  • [7]Bygdell M, Brunlöf G, Wallerstedt SM, Kindblom JM: Psychiatric adverse drug reactions reported during a 10-year period in the Swedish pediatric population. Pharmacoepidemiol Drug Saf 2012, 21:79-86.
  • [8]Patten SB, Love EJ: Neuropsychiatric adverse drug reactions: passive reports to Health and Welfare Canada's Adverse Drug Reaction Database (1965-present). Int J Psychiatry Med 1994, 24:45-62.
  • [9]Vilhelmsson A, Svensson T, Meeuwisse A, Carlsten A: What can we learn from consumer reports on psychiatric adverse drug reactions with antidepressant medication? Experiences from reports to a consumer association. BMC Clin Pharmacol 2011, 11:16. BioMed Central Full Text
  • [10]Robertson HT, Allison DB: Drugs Associated with More Suicidal Ideations Are also Associated with More Suicide Attempts. Plos One 2009, 4:e7312.
  • [11]Hawton K, van Heeringen K: Suicide. The Lancet 2009, 373:1372-1381.
  • [12]European Parliament, Council of the European Union: Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official J Eur Union 2010, L348:74-79.
  • [13]ATC/DDD Index 2014 http://www.whocc.no/atc_ddd_index/ webcite
  • [14]Speirs CJ: Prescription related adverse reaction profiles and their use in risk-benefit analysis. In Iatrogenic diseases. 3rd edition. Edited by D'Arcy PF, Griffin JP. Oxford: Oxford university press; 1986:93-101.
  • [15]Bradford H: The environment and disease: association or causation? ProcRSocMed 1965, 58:295-300.
  • [16]Pariente A, Daveluy A, Laribiere-Benard A, Miremont-Salame G, Begaud B, Moore N: Effect of date of drug marketing on disproportionality measures in pharmacovigilance: the example of suicide with SSRIs using data from the UK MHRA. Drug Saf 2009, 32:441-447.
  • [17]Gunnell D, Irvine D, Wise L, Davies C, Martin RM: Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database. BMJ 2009, 339:b3805.
  • [18]Davis S, King B, Raine JM: Spontaneous reporting- UK. In Pharmacovigilance. 2nd edition. Edited by Mann RD, Andrews EB. Chichester, West Sussex: John Wiley & Sons; 2007:199-215.
  • [19]Martinez C, Rietbrock S, Wise L, Ashby D, Chick J, Moseley J, Evans S, Gunnell D: Antidepressant treatment and the risk of fatal and non-fatal self harm in first episode depression: nested case–control study. BMJ 2005, 330:389-393.
  • [20]Hazell L, Shakir SAW: Under-Reporting of Adverse Drug Reactions: A Systematic Review. Drug Safety 2006, 29:385-396.
  • [21]Martin RM, Kapoor KV, Wilton LV, Mann RD: Underreporting of suspected adverse drug reactions to newly marketed (“black triangle”) drugs in general practice: observational study. BMJ 1998, 317:119-120.
  • [22]Hawton K, Bergen H, Casey D, Simkin S, Palmer B, Cooper J, Kapur N, Horrocks J, House A, Lilley R, Noble R, Owens D: Self-harm in England: a tale of three cities - Multicentre study of self-harm. Soc Psychiatr Psychiatr Epidemiol 2007, 42:513-521.
  • [23]Dal Pan GJ, Lindquist M, Gelperin K: Postmarketing Spontaneous Pharmacovigilance Reporting Systems. In Textbook of Pharmacoepidemiology. Chichester, UK: John Wiley & Sons Ltd; 2013:99-117.
  • [24]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.
  • [25]Aagaard L, Hansen EH: Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011. BMC Pharmacol Toxicol 2013, 14:1-9. BioMed Central Full Text
  • [26]Martin RM, May M, Gunnell D: Did intense adverse media publicity impact on prescribing of paroxetine and the notification of suspected adverse drug reactions? Analysis of routine databases, 2001–2004. Br J Clin Pharmacol 2006, 61:224-228.
  • [27]Stobaugh DJ, Deepak P, Ehrenpreis ED: Alleged isotretinoin-associated inflammatory bowel disease: disproportionate reporting by attorneys to the Food and Drug Administration Adverse Event Reporting System. J Am Acad Dermatol 2013, 69:393-398.
  • [28]Kim CJ, Berlin JA: The Use of Meta-analysis in Pharmacoepidemiology. In Textbook of Pharmacoepidemiology. Edited by Strom BL, Kimmel SE. West Sussex, England: John Wiley & Sons, Ltd; 2006:353-365.
  • [29]Whittington CJ, Kendall T, Fonagy P, Cottrell D, Cotgrove A, Boddington E: Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data. The Lancet 2004, 363:1341-1345.
  • [30]Christensen R, Kristensen PK, Bartels EM, Bliddal H, Astrup A: Efficacy and safety of the weight-loss drug rimonabant: a meta-analysis of randomised trials. The Lancet 2007, 370:1706-1713.
  • [31]Medicines and Healthcare products Regulatory Agency: Varenicline:adverse psychiatric reactions, including depression. Drug Safety Update 2008, 2:2-3.
  • [32]Buggy Y, Cornelius V, Fogg C, Kasliwal R, Layton D, Shakir SA: Neuropsychiatric events with varenicline: a modified prescription-event monitoring study in general practice in England. Drug Saf 2013, 36:521-531.
  • [33]Harrison-Woolrych M, Ashton J: Psychiatric Adverse Events Associated with Varenicline: An Intensive Postmarketing Prospective Cohort Study in New Zealand. Drug Saf 2011, 34:763-772.
  • [34]Thomas KH, Martin RM, Davies N, Metcalfe C, Windmeijer F, Gunnell D: Smoking cessation treatment and the risk of depression, suicide and self-harm in the Clinical Practice Research Datalink: prospective cohort study. BMJ 2013, 347:f5704.
  • [35]US Food and Drug Administration: Updated information on Leukotriene Inhibitors: Montelukas t (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR). Book Updated information on Leukotriene Inhibitors: Montelukas t (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) 2009.
  • [36]Philip G, Hustad C, Noonan G, Malice M-P, Ezekowitz A, Reiss TF, Knorr B: Reports of suicidality in clinical trials of montelukast. J Allergy Clin Immunol 2009, 124:691-696. e696
  • [37]Jick H, Hagberg KW, Egger P: Rate of Suicide in Patients Taking Montelukast. Pharmacotherapy 2009, 29:165-166.
  • [38]Hennen J, Baldessarini RJ: Suicidal risk during treatment with clozapine: a meta-analysis. Schizophr Res 2005, 73:139-145.
  • [39]Kenedi C, Goforth H: A Systematic Review of the Psychiatric Side-Effects of Efavirenz. AIDS Behav 2011, 15:1803-1818.
  • [40]Gibbons RD, Mann JJ: Strategies for quantifying the relationship between medications and suicidal behaviour: what has been learned? Drug Saf 2011, 34:375-395.
  文献评价指标  
  下载次数:4次 浏览次数:32次