Retinoids: Updated measures for pregnancy prevention during retinoids use


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Retinoids are vitamin A derivatives which are used to treat several conditions mainly affecting the skin, including severe acne and psoriasis, while some are used to treat certain forms of cancer. Depending on the type of formulation, retinoids may be taken by mouth or applied on the skin as creams or gels. There are four (4) retinoids registered in Malaysia, namely acitretin and isotretinoin (oral route), adapalene (topical route), and tretinoin (oral or topical route, depending on the product). 



NPRA has received information from the European Medicines Agency (EMA) regarding updated measures for pregnancy prevention during use of oral retinoids, due to the known teratogenicity risk1.


Adverse Drug Reaction Reports:

NPRA has received 88 ADR reports related to retinoids. None of these reports pertain to drug exposure during pregnancy, maternal exposure before pregnancy, or teratogenic adverse effects associated with retinoid-use2.


Advice for Healthcare Professionals:

NPRA has completed a review of this safety issue and concluded that:


A directive [Ruj. Kami: (16) dlm. BPFK/PPP/07/25 Jld. 3] has been issued by NPRA for product registration holders of retinoid products to include a new boxed warning to the product outer packaging, update the local product package insert and consumer medication information leaflet (Risalah Maklumat Ubat untuk Pengguna) related to this safety issue, as well as prepare educational materials. For a full description of the product information update and the Pregnancy Prevention Programme, please refer to this directive.



  1. European Medicines Agency (2018). Updated measures for pregnancy prevention during retinoid use. EMA/165360/2018.
  2. The Malaysian Adverse Drug Reactions database, NPRA [Accessed: October 2019].


This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication