Does the teratogenicity of isotretinoin outweigh its benefits?

Jordan, Amy; Parks, Lauren; Chen, Shuo; Higgins, Kristen S.; Fleischer, Alan B.; Feldman, Steven R.

doi:10.1080/09546630510044904

Cited by 6 publications

(3 citation statements)

References 6 publications

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“…Public health agencies across the world continue to face the task of balancing timely provision and equitable access to potentially life‐changing isotretinoin therapy while minimizing its teratogenicity risks. The quality‐adjusted life year (QALY) benefit of isotretinoin treatment in severe acne is calculated to be 50 times higher than the risk of QALY lost from teratogenicity; the QALY benefit is seven times higher even in treatment of mild acne . Thus, even accounting for the dreadful teratogenic effects, the significant benefits of isotretinoin far outweigh its risks.…”

Section: Discussionmentioning

confidence: 99%

A comparative review of the isotretinoin pregnancy risk management programs across four continents

Kovitwanichkanont

Driscoll

2018

Int J Dermatology

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Isotretinoin has revolutionized the treatment of severe acne vulgaris, a condition which if left untreated may result in significant socio-psychological implications for those affected. Timely access to isotretinoin therapy is important to avoid the risks of potential physical and emotional scarring. However, due to its high risks of teratogenicity, isotretinoin must be used with care in females of childbearing potential. Since isotretinoin's introduction, numerous risk management programs have been implemented across the world in an attempt to prevent isotretinoin use in pregnancy. This paper aims to provide an evidence-based review of the risk management programs for isotretinoin in Australia, Europe, Singapore, New Zealand, and the United States of America. The effectiveness of these programs and the factors leading to isotretinoin exposure in pregnancy are critically analyzed in an effort to inform the future direction with respect to designing the ideal regulatory program. Stringent risk management programs, such as the iPLEDGE in the US and Pregnancy Prevention Program (PPP) in Europe, may not be effective in reducing the risks of fetal exposure to isotretinoin when used alone. There is evidence that such strenuous regulation results in increased fear of teratogenic risks but does not translate into a reduced rate of pregnancies exposed to isotretinoin. A successful program must prioritize education about effective contraception, while minimizing any extraneous requirements, to ensure that women are not inadvertently undertreated for acne.

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Section: Discussionmentioning

confidence: 99%

A comparative review of the isotretinoin pregnancy risk management programs across four continents

Kovitwanichkanont

Driscoll

2018

Int J Dermatology

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“…26 It is clear that the rate of pregnancy for women on isotretinoin therapy is lower than that of the general population, even when compared with general contraception use. 27 Yet the FDA would like to reduce the numbers of isotretinoin-exposed pregnancies to zero.…”

Section: Goals Of Ipledgementioning

confidence: 99%

iPLEDGE Allegiance to the Pill: Evaluation of Year 1 of a Birth Defect Prevention and Monitoring System

Schonfeld¹,

Amoura

Kratochvil³

2009

J. Law. Med. Ethics

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The United States Food and Drug Administration (FDA), in collaboration with pharmaceutical manufacturers, have recently implemented a heavily revised risk-management program for patients on isotretinoin (Accutane), a drug with known and pronounced teratogenic effects. This revised risk management plan places significant burdens on both providers and patients in the hopes of achieving its goal of reducing fetal exposure to isotretinoin. The main focus of this paper is to discuss the burdens of various aspects of the program in relationship to potential corresponding benefits. In particular, we evaluate the pregnancy rates of women on isotretinoin therapy compared with that of the general population and the rate changes based on the risk management programs. Additionally, we investigate whether the benefits of the program for women have increased as the benefits have risen. We devote special attention to the ethical implications of the intent of the program and to an analysis of the ethical justification of the restrictions placed on women of childbearing potential (WCP) as it compares to the risk-benefit relationship of using isotretinoin.

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“…There are both risks and benefits to isotretinoin. There has been some effort to quantify and compare these risks and benefits [ 37 ]. Despite patients' and physicians' efforts at pregnancy prevention, there are still a limited number of fetal isotretinoin exposures.…”

Section: Steven R Feldman's Viewpoint: a Balanced Approach May Be Thmentioning

confidence: 99%

What Is the Best Approach to Reducing Birth Defects Associated with Isotretinoin?

Abroms¹,

Maibach²,

Lyon-Daniel³

et al. 2006

PLoS Med

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Background to the debate: Isotretinoin is an effective treatment for severe acne, a condition which can be physically, emotionally, and socially disabling. Because the drug is teratogenic, causing severe birth defects, women taking the drug are directed to avoid pregnancy. In the United States, a series of risk reduction programs have been implemented that aim to prevent pregnant women from taking the drug and to prevent women taking it from getting pregnant. The most recent, and most stringent, is an Internet-based, performance-linked system called iPLEDGE, which tries to ensure that the drug is dispensed only when there is documentary proof that the patient is not pregnant and is using two forms of birth control. Is iPLEDGE the best way to reduce isotretinoin birth defects, or is it an unproven and overly burdensome system?

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Does the teratogenicity of isotretinoin outweigh its benefits?

Cited by 6 publications

References 6 publications

A comparative review of the isotretinoin pregnancy risk management programs across four continents

A comparative review of the isotretinoin pregnancy risk management programs across four continents

iPLEDGE Allegiance to the Pill: Evaluation of Year 1 of a Birth Defect Prevention and Monitoring System

What Is the Best Approach to Reducing Birth Defects Associated with Isotretinoin?

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