Retinoids: Updated measures for pregnancy prevention during retinoids use

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Overview:

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). 

 

Background:

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:

  • Oral retinoids are highly teratogenic and are contraindicated in pregnancy.
  • Oral retinoids are contraindicated in women of childbearing potential unless the conditions of the Pregnancy Prevention Programme (PPP) are met, including the following:
    • An assessment of each woman’s potential for becoming pregnant;
    • Pregnancy tests must be performed before starting treatment, during and after treatment;
    • The patient understands the need for at least one highly effective method of contraception (i.e. a user-independent method of contraception such as intrauterine device) or two complementary user-dependent methods of contraception (such as oral contraceptive pills and condoms) before, during and after treatment;
    • A risk acknowledgement form for patients and prescribers to go through and confirm that appropriate advice has been given and understood.
    • The patient understands the need for frequent follow-up (e.g. on a monthly basis);
    • The updated educational materials provided should be used to guide the discussion about the risks of oral retinoids before prescribing to women of childbearing potential.
    • Despite negligible systemic absorption following topical application, as a precaution, topical retinoids are contraindicated in pregnant women and in women planning a pregnancy.

 

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.

 

References:

  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].

 

DISCLAIMER
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

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

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  • Last Modified: Thursday 12 December 2019, 15:20:06.
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