A Pregnancy-Prevention Program in Women of Childbearing Age Receiving Isotretinoin

Mitchell, Allen A.; Bennekom, Carla M. Van; Louik, Carol

doi:10.1056/nejm199507133330206

Cited by 158 publications

(124 citation statements)

References 10 publications

(10 reference statements)

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“…[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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Section: Discussionmentioning

confidence: 99%

Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy

Henry

Dormuth

Winquist

et al. 2016

CMAJ

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“…Although there were variations in the doses prescribed, cational campaigns by the manufacturer, including pregvirtually all patients received 0.5-1.0 mg/kg/day, In 4 out of nancy prevention programmes, have been very successful 9 clinics, the dose regimen usually stalled at 0.5 mg/kg [32,33]. Furthermore, the required 1-month post-therapy daily and increased to 1.0 mg/kg/day, but in 2 centres most contraceptive period affords a respectable safety margin patients were started on therapy at 1.0 mg/kg/day.…”

Section: Roaccutane Treatment Guidelinesmentioning

confidence: 99%

“…In Europe, patients with less severe acne who ought to be prescribed oral isotretinoin are likely to visit a private practising der-female patient and physician [30][31][32]. Women of childmatologist rather than a hospital dermatologist, whereas the bearing potential must have a negative pregnancy test as European hospital/university specialist is more likely to see well as practise effective contraception during and for 1 month after completing therapy [31][32][33]. Formalized edu- the m ore severe cases o f acne.…”

Section: Roaccutane Treatment Guidelinesmentioning

confidence: 99%

Roaccutane Treatment Guidelines: Results of an International Survey

et al. 1997

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Background: Oral isotretinoin (Roaccutane®) revolutionized the treatment of acne when it was introduced in 1982. Methods: Twelve dermatologists from several countries with a special interest in acne treatment met to formally review the survey of their last 100 acne patients treated with oral isotretinoin. The primary purpose of the survey was to identify the types of acne patients who were prescribed oral isotretinoin and how the patients were managed. Results: Of the 1,000 patients reviewed, 55% of those who received oral isotretinoin had those indications treated historically, i.e. severe nodular cystic acne or severe inflammatory acne, not responding to conventional treatment. Forty-five percent of patients who were prescribed oral isotretinoin however had either moderate or mild acne. Most patients in this group had moderate acne (85%). However, 7.3% had mild acne on physical examination. The criteria for prescribing oral isotretinoin in this less severe group of patients included acne that improves < 50% after 6 months of conventional oral antibiotic and topical combination therapy, acne that scars, acne that induces psychological distress and acne that significantly relapses during or quickly after conventional therapy. Treatment is usually initiated at daily doses of 0.5 mg/kg (but may be higher) and is increased to 1.0 mg/kg. Most of the physicians aimed to achieve a cumulative dose of > 100–120 mg/kg. Mucocutaneous side-effects occur frequently but are manageable while severe systemic side-effects are rarely problematic (2%). The teratogenicity of oral isotretinoin demands responsible consideration by both female patients and their physicians. Significant cost savings when treating acne patients with oral isotretinoin as compared to other treatment modalities were further proven in this study. Conclusions: Our recommendation is that oral isotretinoin should be prescribed not only to patients with severe disease but also to patients with less severe acne, especially if there is scarring and significant psychological stress associated with their disease. Acne patients should, where appropriate, be prescribed isotretinoin sooner rather than later.

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“…An evaluation of the program in 1995 showed that despite 99% of patients recalling being told to avoid pregnancy, 36% failed to receive a pregnancy test before starting treatment. 12 An assessment in 2000 concluded that the program was unable to adequately prevent pregnancies during treatment, suggesting the need for improvement. 13 In April 2002, the System to Manage Accutane-Related Teratogenicity (SMART) program began in the US to prevent women from starting isotretinoin therapy during pregnancy and to prevent conception during treatment.…”

Section: Preventing Fetal Exposure To Isotretinoinmentioning

confidence: 99%

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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A Pregnancy-Prevention Program in Women of Childbearing Age Receiving Isotretinoin

Abstract: The pregnancy rate among women receiving isotretinoin therapy was substantially lower than that in the general population and was compatible with the characteristics and behavior of the enrolled women.

Cited by 158 publications

References 10 publications

Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy

Occurrence of pregnancy and pregnancy outcomes during isotretinoin therapy

Roaccutane Treatment Guidelines: Results of an International Survey

Pregnancy and isotretinoin therapy

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