The impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system

Shin, Jennifer; Cheetham, T. Craig; Niu, Fang; Kass, Elizabeth M.; Yoshinaga, Monica A.; Sorel, Mike; McCombs, Jeffrey S.

doi:10.1016/j.jaad.2010.09.017

Cited by 101 publications

(93 citation statements)

References 7 publications

(14 reference statements)

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“…US studies have shown that the impact of the iPLEDGE program also appears to have been modest in terms of increased uptake of oral contraceptives and reduced numbers of exposed pregnancies. 23,24 It is clear from this experience and from studies in Europe that modifying contraceptive behav iour in this setting is difficult. Nevertheless, medical practitioners and patients must be con stantly reminded of the risks of isotretinoin to the fetus and must adhere to the policy that mandates effective contraceptive measures.…”

Section: Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy

Henry

Dormuth

Winquist

et al. 2016

CMAJ

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Section: Resultsmentioning

confidence: 99%

“…[5][6][7][8][22][23][24] One study reported a risk of becoming pregnant while taking isotretinoin of 8 per 1000 personyears of treat ment. 22 This is lower than the annual rate calcu lated for Canada and is likely to be an underesti mate because of underreporting to voluntary registries.…”

Section: Discussionmentioning

confidence: 99%

Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy

Henry

Dormuth

Winquist

et al. 2016

CMAJ

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“…However, the program still does not appear to have solved the issue of foetal exposure to isotretinoin. Shin et al [16] recently reported 29 foetal exposures out of 9912 courses of treatment with the drug.…”

Section: Discussionmentioning

confidence: 99%

Systemic Isotretinoin Treatment and Pregnancy: A Longitudinal Cohort Study from Turkey

Özyurt¹,

Kaptanoğlu²

2015

Eurasian J Med

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Objective: Isotretinoin is known to be the most effective treatment of severe and persistent acne. However, one of the most important adverse effects of this drug is known to be teratogenicity. In this regard, tests are administered before initiating the treatment, to assure that an unknown pregnancy is not present and accordingly, patients are advised to take contraceptive precautions during their systemic isotretinoin treatments. On the contrary, many cases of unwanted pregnancies and relevant abortuses have been reported all over the world. In the Turkish literature, only a few reports have been identified about foetal exposure to isotretinoin. Materials and Methods:In this respect, a study was carried out on fifty-seven female patients, aiming to fulfil the gap of information mentioned above. Female patients, with ages ranging between 14 and 35 years, were recruited to the study and they were administered isotretinoin treatments (cumulative dose of 120 mg/kg) for an average period of 6 months. The patients were followed up during and after the treatment for a total period of 18 months. Results:As a result, it has been observed that none of the patients got pregnant during the treatment period and relevantly, no abortuses or foetal abnormalities were recorded. Moreover, none of the patients got pregnant 12 months after the termination of the treatment. Additionally, the socio-demographic analysis of the patients indicates that most of the patients were single and 81% of the patients were sexually inactive. Conclusion:Our findings suggest that the low reportage of teratogenicity due to isotretinoin usage in Turkey could be due to several reasons, such as the sociocultural profile of the female patients undertaking the isotretinoin treatment, and strict adherence to contraceptive methods, and/or underreporting of teratogenic incidents due to lack of studies held in cooperation with obstetricians.Keywords: Acne, isotretinoin, pregnancy, contraception, teratogenicity Özet Amaç: İzotretinoin şiddetli ve inatçı aknenin bilinen en etkili tedavisidir. Ancak bu ilacın en önemli yan etkilerinden biri teratojenik olmasıdır. Bu sebepten tedavi öncesinde bilinmeyen bir gebelik durumu olup olmadığını ortaya çıkarmak için testler yapılmakta ve beraberinde hastaların sistemik izotretinoin tedavileri boyunca kontraseptif önlemler almaları önerilmektedir. Buna rağmen dünyanın pek çok ülkesinden istenmeyen gebelikler ve bununla ilişkili düşükler bildirilmektedir. Ancak Türk literatüründe fetal izotretinoin maruziyeti ile ilgili yalnızca birkaç bildiri tespit edilmiştir. Gereç ve Yöntem:Yukarıda belirtilen bu veri eksikliğini gidermeye yönelik olarak 57 kadın hasta geriye dönük olarak değerlendirilmiştir. 14-35 yaş arası kadın hastalar ortalama 6 ay boyunca total kümülatif doz olarak 120 mg/kg izotretinoin tedavisi almıştı. Bu hastalar tedavi süresinde ve sonrasında toplam 18 ay boyunca izlenmişti. Bulgular: Sonuç olarak hiçbir hastanın tedavi sürecinde gebelik yaşamadığı ve dolayısıyla herhangi bir düşük ya da fetal ano...

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“…Shin and colleagues recently reported 29 fetal exposures out of a total of 9912 courses of treatment with the drug. 14 The authors found no evidence that iPLEDGE significantly decreased the risk of fetal exposure compared with the SMART program. Health Canada's Scientific Advisory Panel on isotretinoin has unanimously rejected the idea of a similar registry in Canada.…”

Section: Preventing Fetal Exposure To Isotretinoinmentioning

confidence: 95%

Pregnancy and isotretinoin therapy

Choi

Koren

Nulman

2013

CMAJ

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A 29-year-old woman was given isotretinoin for severe, recalcitrant acne. During the first 3 months of treatment, she was taking an oral contraceptive agent that she had started at the same time as the isotretinoin. After deciding she wanted to become pregnant, the patient stopped taking the contraceptive agent but continued to take iso tretinoin for another 2 months.When the patient became pregnant, she sought advice from the Motherisk program regarding the fetal risks of exposure to iso tretinoin. With counselling, it became apparent that the patient had not understood the connection between isotretinoin and birth defects, and hence the need for continued effective contraception while taking the drug. After repeated counselling, the patient decided to terminate her pregnancy.

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The impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system

Cited by 101 publications

References 7 publications

Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy

Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy

Systemic Isotretinoin Treatment and Pregnancy: A Longitudinal Cohort Study from Turkey

Pregnancy and isotretinoin therapy

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