Implementation of the Harmonized EU Isotretinoin Pregnancy Prevention Programme
- PDF / 106,315 Bytes
- 6 Pages / 496.063 x 711.496 pts Page_size
- 17 Downloads / 186 Views
Drug Saf 2012; 35 (1): 27-32 0114-5916/12/0001-0027/$49.95/0
ยช 2012 Adis Data Information BV. All rights reserved.
Implementation of the Harmonized EU Isotretinoin Pregnancy Prevention Programme A Questionnaire Survey among European Regulatory Agencies Ineke Crijns,1,2 Sabine Straus,1,3 Michiel Luteijn,2 Christine Gispen-de Wied,1 June Raine4 and Lolkje de Jong-van den Berg2 1 Medicines Evaluation Board, The Hague, the Netherlands 2 University of Groningen, Department of PharmacoEpidemiology and PharmacoEconomics, Groningen, the Netherlands 3 Erasmus Medical Center, Department of Medical Informatics, Rotterdam, the Netherlands 4 Medicines and Healthcare Products Regulatory Agency, London, UK
Abstract
Background: There is little information on the status of the implementation of the isotretinoin Pregnancy Prevention Programme (PPP) in the EU, and on compliance with this programme by the regulatory agencies. Objective: The aim of the study was to obtain information on implementation of the harmonized PPP of isotretinoin in the EU member states plus Norway and Iceland. Materials and Methods: In January 2009, a questionnaire (request for nonurgent information [NUI]) was sent to all 25 EU member states, plus Norway and Iceland, to collect information on the implementation status of the PPP and its effectiveness. Results: The response rate was 82% (22 of the 27 countries). In 21 of the 27 member states, isotretinoin is marketed and the PPP is in force, and in 18 of the 22 responding countries, the total required elements (seven) following a formal EU review are incorporated in the PPP. Seven member states had additional measures in place. In spite of implementation of the PPP and additional measures, a total of 143 isotretinoin-exposed pregnancies have been reported in 16 of the 22 responding member states since implementation of the harmonized PPP. Conclusions: Despite implementation of the isotretinoin PPP in most member states, isotretinoin-exposed pregnancies were reported. This has led some member states to implement additional measures to the PPP, resulting in inconsistency with the approach agreed in 2003 following the European-wide review. It has been further suggested that common elements should be developed for PPPs for all medicines that are known to carry a high teratogenic risk.
Crijns et al.
28
Background Isotretinoin is a vitamin A derivative, licensed in the EU for the treatment of severe acne that has not responded to other treatments.[1] Like all vitamin A derivatives, isotretinoin is highly teratogenic; the rate of teratogenicity of vitamin A derivatives is comparable to the rate of teratogenicity of thalidomide.[2] In 1982, isotretinoin was licensed in the US and labelled a category X medication (agents that have demonstrated clear risk of fetal abnormalities and whose risks outweigh the benefits of use during pregnancy[3]). The isotretinoin embryopathy consists of craniofacial, cardiac, thymic, and CNS defects, and occurs in an estimated 26% of exposed patients.[2] Exposure of isotretinoin be
Data Loading...
