Abstract
This chapter discusses the succession of pregnancy prevention programmes (PPPs) for isotretinoin, a medicine effective against acne, but with high risks for birth defects and developmental disorders in the child when exposed during pregnancy. Strengthening of PPPs over time was considered necessary by regulators to increase the compliance with these programmes, but the communication for implementing “strict” PPPs in the healthcare system has been one of the most important challenges in the pharmaceutical field, due to its rejection by some opinion leaders among dermatologists and due to differences in cultures and expectations regarding sexual behaviour of women within and between countries. In addition, isotretinoin has been investigated for possible psychiatric adverse effects including suicidal behaviour, which caused media attention and even discussions in parliaments. Moreover, the chapter reflects on the inconclusive evidence to date in this respect and the associated needs for different regulatory action and handling of communication for isotretinoin and other retinoids. The best ways of how to communicate their risks and safe use recommendations will remain subject to discussion with a view to continuous improvement in every country of the world.
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The views expressed in this chapter are the author’s personal views and may not be understood or quoted as being made on behalf of or reflecting the position of her employing organisation, i.e. the Dutch Medicines Evaluation Board, or the European Medicines Agency (EMA) or any of its committees or working parties, where she serves as an expert.
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Crijns, I. (2020). Isotretinoin: Communication for Preventing Birth Defects and Alerting of an Uncertain Risk of Suicide. In: Bahri, P. (eds) Communicating about Risks and Safe Use of Medicines. Adis, Singapore. https://doi.org/10.1007/978-981-15-3013-5_4
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