Prescribing of oral acitretin, alitretinoin and isotretinoin to girls and women of childbearing age and during pregnancy in Germany
Description
- The retinoids acitretin, alitretinoin, and isotretinoin are used in oral form to treat several moderate to severe skin diseases that also affect women of childbearing age. Given that these drugs can cause severe malformations in the child when taken during pregnancy, it is important to ensure that women are not pregnant or do not become pregnant under treatment. Furthermore, the complete elimination of acitretin from the body takes up to three years after the end of therapy, hence pregnancy should also be avoided during this period.
To prevent exposed pregnancies, the drug regulatory authorities have required several risk minimization measures and communicated them in Dear-Doctor letters. The most recent Dear-Doctor letter from 2024 – also based on studies conducted by BIPS – particularly emphasized the consideration of the approved indications and the need for effective contraception. In addition, pregnancy tests should be performed before, during, and after therapy in all women of childbearing age.
From a regulatory perspective, it is important to monitor whether these risk minimization measures are being followed and whether they are effective.
In this context, the prescription patterns of acitretin, alitretinoin, and isotretinoin in women of childbearing age in Germany will be comprehensively described and the occurrence of pregnancies under treatment or after the end of therapy will be assessed. All analyses will be based on health claims data.
The project is funded by the Federal Institute for Drugs and Medical Devices (BfArM) as part of a call for proposals for pharmacovigilance research.
Funding period
- Begin: December 2025
End: May 2027
Sponsor
- Federal Institute for Drugs and Medical Devices