ArticleSaudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society2021
Awareness of isotretinoin use and Saudi FDA pregnancy prevention program in Riyadh, Saudi Arabia: A cross-sectional study among female patients.
Article in Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 9 citations in OpenAlex.
- Safety and Predictors of Clinically Significant Adverse Effects of Isotretinoin in Acne Vulgaris: A Retrospective Cohort Study from Saudi Arabia.Clinical, cosmetic and investigational dermatology · 2026Article
- The Perception of Contraceptive Practice Among Female Patients Treated With Isotretinoin in Saudi Arabia.Cureus · 2024Article
- Fetal exposure to isotretinoin in Saudi Arabia: a multicenter real-world data analysis from 2015 to 2020.Therapeutic advances in drug safety · 2024Article
- Community pharmacists' knowledge and awareness about isotretinoin therapy and its dispensing practice in Jordan.Heliyon · 2023Article
- An Assessment of the Knowledge of Oral Isotretinoin (Roaccutane) Treatment Among Pharmacy Students in Saudi Arabia.Cureus · 2023Article
- Knowledge on the Use of Isotretinoin and Its Side Effects and Awareness towards Saudi FDA-Pregnancy Prevention Program among the Female Acne Patients: A Northern Saudi Study.Medicina (Kaunas, Lithuania) · 2022Article
- A Multicenter Cohort Study Evaluating the Teratogenic Effects of Isotretinoin on Neonates.Children (Basel, Switzerland) · 2022Article
- Patients' Knowledge and Information Needs about Isotretinoin Therapy Use in Jordan.International journal of clinical practice · 2022Article
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Authors and funding
11 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOral isotretinoin is an effective agent for the treatment of severe cystic acne. Isotretinoin is a teratogen; there is an increased risk of congenital defects in infants exposed to the drug in the uterus. The Saudi Food and Drug Authority (SFDA) has implemented a pregnancy prevention program (PPP) to protect females from those teratogenic effects.
objectivesTo investigate the awareness of women, of reproductive age who were using Isotretinoin or used it previously, about isotretinoin use and the SFDA-approved PPP in Riyadh, Saudi Arabia.
methodsThis cross-sectional study was conducted during the period from June to October 2019. A questionnaire was developed based on the published literature and the PPP recommendations. The study was carried out online among female patients who were on Isotretinoin therapy or have used it previously in Riyadh city. The Statistical Package for Social Sciences (SPSS for Windows, version 24) was used to analyze the study data.
resultsDuring the study period, 483 patients participated in the study. Among them, 97.3% reported that they used the drug based on a doctor's prescription, 94.6% were aware of Isotretinoin's teratogenic effect, and 30.6% confirmed their awareness of the PPP. Amongst the participants, 9.1% (n = 44) used Isotretinoin while being married or planning to get married within a one-month period after using it. Concerning the use of two contraceptive methods according to the PPP guidelines, of the participants, 43.2% reported that they have been informed by their healthcare providers to use two contraceptive methods before starting the medication. Also 43.2% reported that they have been informed to use two contraceptive methods while using the medication, and 50% reported that they have been informed to use two contraceptive methods for one month after stopping the medication. Regardless of the information they had, participants' actual practice, was as follow: 15.9% used two contraceptive methods before starting the medication, 15.9% used two contraceptive methods during the treatment, and 13.6% used two contraceptive methods for one month after stopping the medication.
conclusionsAlthough this study revealed that the vast majority of participants were aware of isotretinoin's teratogenic effect, still a considerable number of them had no idea about the PPP. This issue needs to greatly be addressed to minimize the risk of teratogenicity.
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