Authors
1 Research Unit of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark, Odense, Denmark
2 Department of Pharmacy, Section for Social and Clinical Pharmacy, University of Copenhagen, Denmark
Abstract
Objective: To characterize adverse drug reactions (ADRs) reported by European (EU)
consumer for antineoplastic and immunomodulating medications.
Methods: ADRs reported by consumers of antineoplastic and immunomodulating
medications (anatomical therapeutic chemical [ATC]) group L from 2007 to 2011 and
located in the EU ADR database, EudraVigilance, were analyzed. Data were categorized
with respect to age and sex, category, and seriousness of reported ADRs and medications.
The unit of analysis was one ADR.
Findings: We located 9649 ADRs reported for antineoplastic and immunomodulating
medications, which approximately 15% of were serious, including 26 deaths. Less than 5%
of ADRs were reported in children. Totally 73% of ADRs were reported for women and
27% for men. The majority of ADRs were of the type “general disorders and administration
site conditions” (54% of total ADRs), followed by “skin and subcutaneous disorders”
(7% of total ADRs), and “infections and infestations” (6% of total ADRs). Reports
encompassed medicines from the therapeutic groups: Imunosupressants (ATC group L04)
(90% of all ADRs), immunostimulants (ATC group L03) (6% of all ADRS), and antineoplastic
agents (ATC group L01) (4% of all ADRs). Many ADRs were reported for etanercept (Enbrel®),
Interferon beta (Betaferon®/Extavia®), and imatinib (Glivec®) with only few being serious.
Conclusion: In general, consumers reported a high number of ADRs from the use of
antineoplastic and immunostimulant medications and many of these were classified as
non‑serious. This indicates that consumers are interesting in reporting ADRs, but since
the investigated substances potentially have the risk of causing many ADRs, we expected a
higher number of serious ADRs.
Keywords
- Aagaard L, Strandell J, Melskens L, Petersen PS, Holme
Hansen E. Global patterns of adverse drug reactions over a
decade: Analyses of spontaneous reports to VigiBase™. Drug
Saf 2012;35:1171‑82.
2. Hansen EH. Technology assessment in a user perspective–
Experiences with drug technology. Int J Technol Assess Health
Care 1992;8:150‑65.
3. Aagaard L, Hansen EH. Information about ADRs explored by
pharmacovigilance approaches: Aqualitative review of studies
on antibiotics, SSRIs and NSAIDs. BMC Clin Pharmacol
2009;9:4.
4. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient
reporting of suspected adverse drug reactions: A review of
published literature and international experience. Br J Clin
Pharmacol 2007;63:148‑56.
5. Medawar C, Herxheimer A. A comparison of adverse drug
reaction reports from professionals and users, relating to risk
of dependency and suicidal behaviour with paroxetine. Int J
Risk Saf Med 2003;16:5‑19.
6. Aagaard L, Nielsen LH, Hansen EH. Consumer reporting of
adverse drug reactions: Aretrospective analysis of the Danish
adverse drug reaction database from 2004 to 2006. Drug Saf
2009;32:1067‑74.
7. de Langen J, van Hunsel F, Passier A, de Jong‑van den Berg L,
van Grootheest K. Adverse drug reaction reporting by patients
in the Netherlands: Three years of experience. Drug Saf
2008;31:515‑24.
8. Aagaard L, Hansen EH. Consumers’ reports of suspected
adverse drug reactions volunteered to a consumer magazine.
Br J Clin Pharmacol 2010;69:317‑8.
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. - 10. Van Hunsel F, Härmark L, Pal S, Olsson S, van Grootheest K.
Experiences with adverse drug reaction reporting by patients:
An 11‑country survey. Drug Saf 2012;35:45‑60.
11. European Commission. The EU Pharmacovigilance System.
Available from: http://www.ec.europa.eu/health/human‑use/
pharmacovigilance/index_en.htm.[Last accessed 2012 Dec 14].
12. European Medicines Agency. Note for guidance–
Eudravigilance human – Processing of safety messages and
individual case safety reports (ICSRs). EMA/H/20665/04/
Final Rev. 2. Available from: http://www.ema.europa.eu/./
en_GB/document_library/Regulatory_and_procedural_
guideline/2009/11/WC500015697.pdf. [Last accessed
2012 Dec 14].
13. Office Journal of the European Commission. Regulation (EC)
no 1049/2001 of the European parliament and of the council of
30 May 2001 regarding public access to European Parliament,
council and commission. L145/43. Available from: http://www.
europarl.europa.eu/register/./r1049_en.pdf. [Last accessed
2012 Dec 14].
14. Pharmacovigilance: Medicinal products for human use and
veterinary products. Vol. 9. Available from: http://www.
ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev9.
htm. [Last accessed 2012 Dec 14].
15. MedDRA. Available from: http://www.meddramsso.
com. [Last accessed 2012 Dec 14].
16. WHO Collaboration Centre for Drug Statistics Methodology,
2007. Available from: http://www.whocc.no/atc_ddd_
index/. [Last accessed 2012 Dec 14].
)