(206) Evaluation of The Safety Information in "Fertility, Pregnancy and Lactation" Section of Product Information in Saudi Arabia

Sunday, August 28, 2022

8:00 AM – 1:45 PM CEST

Location: Hall C

Publication Number: 1251

Presenting Author(s)

Sara Waleed ALMishari, MPH, PharmD
– Drug safety specialist, Saudi Food and Drug Authority, Riyadh, Al Riyadh, Saudi Arabia

Co-Author(s)

Eman Ali Alghamdi, PharmD
– Drug Safety and Risk Management Department, Executive Directorate of Pharmacovigilance, Drug Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia, Al-Riyadh, Ar Riyad, Saudi Arabia
Mona A. Almaghrabi
– Drug Safety Specialist , Saudi Food and Drug Authority, Riyadh, Saudi Arabia
Nouf Alfadel
– Saudi Food and Drug Authority (SFDA), Ar Riyad, Saudi Arabia
Fawaz F. Alharbi, MSc, PhD.
– Saudi Food & Drug Authority (SFDA), Saudi Arabia

Background: During the development of a new medicine, pregnant and breastfeeding women are usually excluded from clinical trials. Therefore, the post-marketing data are critically important to obtain knowledge on potential risks of medications during pregnancy and lactation.

Objectives: To review the information on the use of medicines during pregnancy and lactation in the current Summary of Product Characteristics (SPCs) of medications registered by the Saudi Food and Drug Authority (SFDA).

Methods: The SPCs of 46 of teratogenic potential medications (20 immunosuppressant agents, 13 anti-epileptics, 6 antipsychotics, and 7 antidepressants) authorized by SFDA were retrieved from the internal database at SFDA (EURS: EXTEDO Universal Review System). The information in Section 4.6 ‘Fertility, Pregnancy and Lactation’ of included SPCs was assessed and classified as complete or incomplete information depending on whether (or not) they provided complete information regarding medicine use in pregnancy and lactation based on the available evidence.

Results: We assessed the information in the ‘Fertility, Pregnancy and Lactation’ section of 29 (63%) SPCs as incomplete information involving 59 subsections. The information was lacked with respect to use of medicine in pregnancy subsection in 20 SPCs, lactation subsection in 14 SPCs, effect on fertility subsection in 15 SPCs and in effect women of childbearing potential subsection in 10 SPCs.

Conclusions: Important information on the use of medications during pregnancy and lactation was lacked in the local SPCs. Further efforts are required to keep the SPCs updated with regard to post authorization data on the exposure to medicinal products especially during pregnancy and lactation.