Women's experiences regarding isotretinoin risk reduction counseling in Riyadh

Algoblan, Shoug; Bakhsh, Sehrish; Alharithy, Ruaa

doi:10.4103/jdds.jdds_50_18

Cited by 6 publications

(8 citation statements)

References 2 publications

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“…B. Schwarz, Parisi, Williams, et al, 2012;E. B. Schwarz et al, 2007;Stancil et al, 2016;Steinkellner et al, 2010) Isotretinoin 16 (29.1%) (Algoblan et al, 2019;Boucher & Beaulac-Baillargeon, 2006;Brinker et al, 2005;Cheetham et al, 2006;Crijns et al, 2012;Entezari-Maleki et al, 2012;Hogan et al, 1988;Lelubre et al, 2018;Mitchell et al, 1995;Ozyurt & Kaptanoglu, 2015;Pinheiro et al, 2013;Rao et al, 2000;Teichert et al, 2010;Tsur et al, 2008;Uuskula et al, 2018;Werner et al, 2014) Antiepileptic or anticonvulsant medications 5 (9.1%) (Bell et al, 2002;Bhakta et al, 2015;Bosak et al, 2019;Langan et al, 2013;Wieck et al, 2007) Arthritis or lupus medications 4 (7.3%) (Banas et al, 2014;Ferguson et al, 2016;Leverenz et al, 2019;Yazdany et al, 2011) Valproate/valproic acid 4 (7.3%) (Atturu & Odelola, 2015;Gotlib et al, 2016;Mulryan et al, 2018;Paton et al, 2018) Thalidomide or lenalidomide 3 (5.5%) (Brandenburg et al, 2017;Castaneda et al, 2008;Chave et al, 2001) Acitretin 1 (1.8%) (Raguideau et al, 2015) Chemotherapy for breast cancer 1 (1.8%) (Valle et al, 1998) Deferoxamine a...…”

Section: Data Availability Statementmentioning

confidence: 99%

“…Since 2007, implementation of REMS with ETASU have been required by the FDA for medications with serious safety issues like teratogenic medications to ensure that the benefits of a medication outweigh the risks to patients (Leiderman, 2009). Isotretinoin was the most commonly prescribed teratogenic medication covered by the studies included in this review (n = 16; 29.1%) (Algoblan, Bakhsh, Alharithy, 2019;Boucher & Beaulac-Baillargeon, 2006;Brinker et al, 2005;Cheetham et al, 2006;Crijns et al, 2012;Entezari-Maleki et al, 2012;Hogan et al, 1988 Ozyurt & Kaptanoglu, 2015; Pinheiro et al, 2013;Rao et al, 2000;Teichert et al, 2010;Tsur et al, 2008;Uuskula et al, 2018;Werner et al, 2014). This may be because of two reasons.…”

Section: Risk Managementmentioning

confidence: 99%

“…Firstly, isotretinoin is a relatively old medication that has been in the market since 1982-1983, and has been prescribed under a pregnancy prevention programme since 1988 (Crijns, Straus, Gispen-de Wied, & de Jong-van den Berg, 2011). Secondly, it is one of the most cost-effective acne treatments used by patients from different age groups including women of childbearing age (Algoblan et al, 2019;Bérard et al, 2007;Honein et al, 2004). By contrast, it was observed that there were fewer publications on medications prescribed under more recent risk management programmes such as thalidomide, lenalidomide, and valproic acid (Atturu & Odelola, 2015;Brandenburg et al, 2017;Castaneda et al, 2008;Chave et al, 2001;Gotlib et al, 2016;Mulryan et al, 2018;Paton et al, 2018), indicating a need for further investigation of the safety of these medications in terms of adherence to risk management measures for such medications.…”

Section: Risk Managementmentioning

confidence: 99%

“…B. Schwarz, Parisi, Williams, Shevchik, & Hess, 2012;E. B. Schwarz et al, 2007;Stancil et al, 2016;Steinkellner et al, 2010;Teichert et al, 2010;Uuskula et al, 2018;Wieck et al, 2007), while others used patients surveys (Algoblan et al, 2019;Banas et al, 2014;Bell et al, 2002;Boucher & Beaulac-Baillargeon, 2006;Brandenburg et al, 2017;Brinker et al, 2005;Castaneda et al, 2008;Chang et al, 2018;Ferguson et al, 2016;Goyal et al, 2015;Lelubre et al, 2018;Leverenz et al, 2019;Mitchell et al, 1995;Ozyurt & Kaptanoglu, 2015;Rao et al, 2000;E. B. Schwarz, Mattocks, et al, 2013;Shilalukey et al, 1997;Tsur et al, 2008;Valle et al, 1998;Werner et al, 2014;Yazdany et al, 2011), a combination of medical records and patient surveys (Bosak et al, 2019;Entezari-Maleki et al, 2012;Hogan et al, 1988;E.…”

Section: Risk Managementmentioning

confidence: 99%

“…B. Schwarz, Mattocks, et al, 2013;E. B. Schwarz et al, 2007;Stancil et al, 2016;Steinkellner et al, 2010;Teichert et al, 2010;Werner et al, 2014;Wieck et al, 2007) Quality assessment Low quality 1 (1.8%) (Martin et al, 2008) Medium quality 31 (56.4%) (Algoblan et al, 2019;Atturu & Odelola, 2015;Banas et al, 2014;Bell et al, 2002;Bhakta et al, 2015;Bosak et al, 2019;Brandenburg et al, 2017;Castaneda et al, 2008;Chave et al, 2001;Cheetham et al, 2006;Crijns et al, 2012;DiPietro Mager et al, 2018;Force et al, 2012;Fritsche et al, 2011;Gotlib et al, 2016;Hogan et al, 1988;James et al, 2007;Lelubre et al, 2018;Mitchell et al, 1995;Mulryan et al, 2018;Ozyurt & Kaptanoglu, 2015;Paton et al, 2018;Pinheiro et al, 2013;Raguideau et al, 2015;Rao et al, 2000;Ruiter et al, 2012;E. B. Schwarz et al, 2005;Shilalukey et al, 1997;Steinkellner et al, 2010;Valle et al, 1998;Wieck et al, 2007) High quality 23 (41.8%)…”

Section: Data Availability Statementmentioning

confidence: 99%

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Risk management of teratogenic medicines: A systematic review

Shroukh

Steinke

Willis

2020

Birth Defects Research

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Aim: To systematically identify studies of implementing risk management measures when prescribing teratogenic medicines for women of childbearing age and studies reporting risk perceptions of teratogenic medications. Methods: MEDLINE, CINAHL, Scopus, EMBASE, and International Pharmaceutical Abstracts were searched. Studies were included in the risk management section if they reported any of the following risk management measures: teratogenic counseling, contraceptive counseling, pregnancy testing before starting treatment, pregnancy testing during treatment, use of contraception before starting treatment, and use of contraception during treatment. Studies were included in the perceptions section if they reported perceived teratogenic risk as numerical value. Results: Fifty-five studies were included in the risk management section and seven studies were included in the perceptions sections. Prevalence of risk management measures varied as follows: teratogenic counseling (9.5%-99.3%), contraceptive counseling (6.1%-98%), pregnancy testing before starting treatment (0%-95.1%), pregnancy testing during treatment (12.7%-100%), contraception use before starting treatment (15.7%-94%), and contraception use during treatment (1.7%-100%). A proper estimation of the teratogenic risk was reported for thalidomide (by general practitioners and obstetric/gynecologists), for etretinate (by pregnant women), and for misoprostol (by pregnant and nonpregnant women). An underestimation was reported for warfarin and retinoids (by general practitioners and obstetric/gynecologists). And overestimation was reported for thalidomide, valproate, lithium, isotretinoin, phenytoin, warfarin and etretinate by different populations. Conclusion: Considerable variation in the implementation of risk management measures when prescribing teratogenic medicines to women of childbearing age is reported in the literature. A common tendency to overestimate the risk of teratogenic medications was evident.

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Section: Data Availability Statementmentioning

confidence: 99%

Section: Risk Managementmentioning

confidence: 99%

Section: Risk Managementmentioning

confidence: 99%

Section: Risk Managementmentioning

confidence: 99%

Section: Data Availability Statementmentioning

confidence: 99%

See 3 more Smart Citations

Risk management of teratogenic medicines: A systematic review

Shroukh

Steinke

Willis

2020

Birth Defects Research

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Awareness of isotretinoin use and Saudi FDA pregnancy prevention program in Riyadh, Saudi Arabia: A cross-sectional study among female patients

Ibrahim

Alshatri

Alsuwaidan

et al. 2021

Saudi Pharmaceutical Journal

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Introduction Oral 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. Objectives To 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. Methods This 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. Results During 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. Conclusions Although 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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Fetal exposure to isotretinoin in Saudi Arabia: a multicenter real-world data analysis from 2015 to 2020

Albogami,

Almadani,

Almohareb

et al. 2024

Therapeutic Advances in Drug Safety

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Background: Despite its high efficacy in treating severe acne, isotretinoin is associated with serious side effects, including teratogenicity. However, the extent of isotretinoin exposure during pregnancy in Saudi Arabia remains unknown. Objectives: This study aims to quantify the extent of fetal exposure to isotretinoin in Saudi Arabia and to evaluate adherence to risk minimization measures approved by the Saudi Food and Drug Authority. Design: Retrospective cohort study. Methods: This multicenter retrospective study included a cohort of 6233 women of childbearing ages (WCBAs) who had received isotretinoin therapy between 2015 and 2020. Exposure to isotretinoin use was ascertained from patients’ electronic health records and was defined as any positive pregnancy test (urine or serum) or any diagnosis or procedure related to pregnancy occurring during the risk period. We defined the risk period starting from isotretinoin initiation until up to 30 days after the last prescription. We quantified the overall incidence proportion of fetal exposure to isotretinoin by dividing the number of pregnancy cases during the risk period by the total study sample of WCBAs. Results: The cohort predominantly included young females (20–29 years), with a mean age of 24 years. Only 5% of the WCBAs used contraceptives, and 10% have a record of pregnancy testing. During the risk period, 34 pregnancies were identified, yielding a cumulative pregnancy incidence of 5.6 per 1000 WCBAs. Pregnancy outcomes for exposed women were about 5% of births had defects, while abortions accounted for 14.3% of pregnancies. Conclusion: Our investigation shows an alarming incidence of fetal exposure to isotretinoin in Saudi Arabia, substantially surpassing global estimates. These results underscore a critical need for enhanced interventions and robust risk minimization strategies tailored to the distinct challenges faced by the Saudi Arabian population.

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Women's experiences regarding isotretinoin risk reduction counseling in Riyadh

Cited by 6 publications

References 2 publications

Risk management of teratogenic medicines: A systematic review

Risk management of teratogenic medicines: A systematic review

Awareness of isotretinoin use and Saudi FDA pregnancy prevention program in Riyadh, Saudi Arabia: A cross-sectional study among female patients

Fetal exposure to isotretinoin in Saudi Arabia: a multicenter real-world data analysis from 2015 to 2020

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