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Abstract

Background: The safety and pattern of use of a medicinal product cannot be fully studied prior to its marketing. In Denmark, the Danish Health and Medicines Authority (DHMA) monitors marketed drugs. An available source is the Register of Medicinal Product Statistics (RMPS), which can possibly be used for these purposes. Objective: To investigate utilisation and potential safety issues of relatively new antidepressants containing the active ingredient duloxetine (Cymbalta^® and Xeristar^®) by using dispensing data available in the RMPS. Methods: A retrospective study using dispensing data was designed to estimate the size and composition of the user population and patterns of use of the antidepressants Cymbalta^® and Xeristar^® (active ingredient: duloxetine) in the period from 1 January 2005 to 31 December 2010. Data were retrieved from Epikur, a register subset of the RMPS. Results: Both women and men in different age groups used duloxetine for depression. Some users switched to another antidepressant. Prescription of the drug for persons below the age of 18 years revealed a potential safety issue. Concomitant treatment with Cymbalta^® or Xeristar^® and fluvoxamine, isocarboxazid, Yentreve^®, or ciprofloxacin also revealed potential safety issues. Conclusions: The present study indicated that the RMPS is applicable in monitoring the pattern of use and potential safety issues related to duloxetine when it is prescribed for depression. Switching to other antidepressants could reflect some potential safety issues. Use of duloxetine for persons below the age of 18 years and its concomitant use with contraindicated drugs also indicated potential safety issues.

Keywords

Cymbalta®Danish Health and Medicines Authority (DHMA)drug utilisation duloxetine marketed drugs pattern of drug utilisation Register of Medicinal Product Statistics (RMPS)safety monitoring Xeristar®

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References

Bate

Lindquist

Edwards

. The application of knowledge discovery in databases to post-marketing drug safety: example of the WHO database. Fundam Clin Pharmacol 2008;22:127–40.

Bahri

Tsintis

Waller

. Regulatory pharmacovigilance in the EU. In: Mann

Andrews

(eds). Pharmacovigilance, 2nd ed. West Sussex: John Wiley & Sons Ltd, 2007, pp. 185–98.

Glasser

Salas

Delzell

. Importance and challenges of studying marketed drugs: what is a phase IV study? Common clinical research designs, registries, and self-reporting systems. J Clin Pharmacol 2007;47:1074–86.

Harmark

van Grootheest

. Pharmacovigilance: methods, recent developments and future perspectives. Eur J Clin Pharmacol 2008;64:743–52.

Kimland

Odlind

. Off-label drug use in pediatric patients. Clin Pharmacol Ther;91:796–801.

World Health Organization. The importance of pharmacovigilance. Geneva: WHO, 2002.

Strom

Kimmel

Hennessy

. The future of pharmacoepidemiology. In: Strom

Kimmel

Hennessy

. (eds). Pharmacoepidemiology, 5th ed. Wiley-Blackwell, 2012, pp. 893–95.

Wise

Parkinson

Raine

. New approaches to drug safety: a pharmacovigilance tool kit. Nat Rev Drug Discov 2009;8:779–82.

Health and Medicines Authority. Licensing of medicines, http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines (accessed 6 January 2012).

10.

Health and Medicines Authority. Marketing authorisation, http://laegemiddelstyrelsen.dk/en/topics/authorisation-and-supervision/licensing-of-medicines/marketing-authorisation (accessed 10 February 2012).

11.

Health and Medicines Authority. Registration and monitoring of side effects, http://laegemiddelstyrelsen.dk/en/topics/side-effects-and-trials/side-effects/registration-and-monitoring (accessed 14 February 2012).

12.

Health and Medicines Authority. Side effects, http://laegemiddelstyrelsen.dk/en/topics/side-effects-and-trials/side-effects (accessed 15 February 2012).

13.

MEDSTAT, http://www.medstat.dk/da/view/datagrundlag_og_beskrivelse (accssed 19 December 2011).

14.

European Medicines Agency, http://www.ema.europa.eu/ema/ (accessed 9 December 2011).

15.

Kildemoes

Sorensen

Hallas

. The Danish National Prescription Registry. Scand J Public Health 2011;39(7 Suppl):38–41.

16.

Register of Medicinal Product Statistics, http://www.ssi.dk/English/HealthdataandICT/Health%20data/Registries/Register%20of%20Medicinal%20Products%20Statistics.aspx

17.

Furu

Wettermark

Andersen

. The Nordic countries as a cohort for pharmacoepidemiological research. Basic Clin Pharmacol Toxicol 2010;106:86–94.

18.

Statens Serum Institut. Forbruget af antidepressiva 2001–2011, http://www.ssi.dk/Sundhedsdataogit/Analyser%20og%20rapporter/Lagemiddelforbrugsanalyser/2012/Antidepressiva.aspx (accessed 10 May 2012).

19.

Oedegaard

Riise

Dilsaver

. A pharmaco-epidemiological study of migraine and antidepressant medications: complete one year data from the Norwegian population. J Affect Disord 2011;129:198–204.

20.

Sundell

Gissler

Petzold

. Antidepressant utilization patterns and mortality in Swedish men and women aged 20–34 years. Eur J Clin Pharmacol 2011;67:169–78.

21.

Kornstein

McEnany

. Enhancing pharmacologic effects in the treatment of depression in women. J Clin Psychiatry 2000;61 (Suppl 11):18–27.

22.

Wittchen

. Generalized anxiety disorder: prevalence, burden, and cost to society. Depress Anxiety 2002;16:162–71.

Prescribing patterns and safety monitoring of duloxetine using the Danish Register of Medicinal Product Statistics as a source

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