Authors
1 1 Clinical Pharmacology, Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark Danish Pharmacovigilance Research Project (DANPREP), Copenhagen, Denmark
2 Section for Clinical and Social Pharmacy, Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark Danish Pharmacovigilance Research Project (DANPREP), Copenhagen, Denmark
Abstract
Objective: To characterise consumer adverse drug reaction (ADR) reports for
phosphodiesterase type 5 (PDE5) inhibitors.
Methods: We included ADR reports submitted by adults to the European ADR
database (EudraVigialnce) from 2007 to 2011. ADRs were classified according to type,
seriousness and age and sex of consumers. The unit of analysis was one ADR.
Findings:Totally,328ADRs were reported for sildenafil and vardenafil,and only 5% of these
were serious.The largest number of reported ADRs was found for sildenafil, i.e., “lack of
efficacy” and/or “drug efficacy decreased” (n = 134) and “headache” (n = 21).
Conclusion: ADRs reported by consumers for PDE5 inhibitors were relatively low, and
only few ADRs were serious.
Keywords
Ann N Y Acad Sci 2002;962:378‑88.
2. Young SE, Mainous AG 3rd, Diaz VA, Everett CJ. Practice
patterns in sildenafil prescribing. Fam Med 2006;38:110‑5.
3. Jones MJ. Internet‑based prescription of sildenafil:
A 2104‑patient series. J Med Internet Res 2001;3:E2.
4. Palit V, Eardley I. An update on new oral PDE5 inhibitors
for the treatment of erectile dysfunction. Nat Rev Urol
2010;7:603‑9.
5. 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.
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. European Medicines Agency. EudraVigilance. Available from:
http://www.eudravigilance.ema.europa.eu/human/index.
asp. [Last accessed 2013 Apr 15].
8. Eudra Lex. 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 2013 Apr 15].