Photos references: https://welzo.com/blogs/skincare/what-is-roaccutane; http://www.daniellesbeautyblog.com/2020/11/roaccutane-diaries-month-one.html
Isotretinoin, a systemic oral retinoid renowned for its efficacy against severe acne, has been a staple in Singapore’s medical landscape since 1990. Currently available under four brands — Acnotin, Nimegen, Oratane, and Roaccutane® — its widespread use prompts a thorough examination of its safety profile. This article delves into the intricacies of isotretinoin’s indications, recent international actions, and local considerations.
Isotretinoin’s primary purpose is addressing severe nodulo-cystic acne unresponsive to conventional treatments. Despite its established efficacy, cautionary notes are sounded for specific patient groups. The absence of studies in pediatric patients under 12 underscores the need for prudence. Additionally, attention is drawn to adolescents aged 12 to 17, especially those with known metabolic or structural bone diseases.
The narrative unfolds into the nuanced realm of psychiatric and sexual adverse events associated with isotretinoin. Acknowledging inconclusive causal relationships highlighted in HSA’s 2018 and 2017 reviews, emphasis is placed on strengthened safety information in local package inserts. These endeavors aim to address potential risks and empower both healthcare providers and patients with informed decision-making.
New Evidence and International Actions:
A panoramic view encompasses the global landscape, bringing attention to the United Kingdom’s Medicines and Healthcare products Regulatory Agency’s (MHRA) pivotal 2019 review. The ensuing changes, including label warnings and heightened oversight for patients under 18, mark a shift in addressing concerns about isotretinoin’s impact on mental health and sexual function. A comparative glance at other regulatory bodies, including the FDA and EMA, reveals varying responses to these concerns.
Local Situation:
The article grounds itself in Singapore’s healthcare scenario, examining local sales data to gauge isotretinoin exposure. Despite a stable trajectory from 2019 to mid-2023, the reported adverse events remain relatively low. However, the complexity of causality assessment and potential under-reporting looms, underscoring the need for continual vigilance.
HSA’s Evaluation and Advisory:
Culminating in the present, the Health Sciences Authority (HSA), in consultation with its Product Vigilance Advisory Committee (PVAC), delivers a considered assessment. Despite acknowledging the favorable benefit-risk profile of isotretinoin, a call to action resonates. Healthcare professionals are urged to integrate a holistic approach, incorporating counseling, screening, and referral mechanisms when prescribing isotretinoin, thereby ensuring patient safety and comprehensive care.
In conclusion, this comprehensive review navigates through the multifaceted landscape of isotretinoin use. As healthcare providers weigh the benefits and risks, informed decision-making and ongoing vigilance are championed to optimize patient outcomes.
HSA: Health Sciences Authority; PVAC: Product Vigilance Advisory Committee; MHRA: Medicines and Healthcare Products Regulatory Agency
Link to the original news article:
https://www.hsa.gov.sg/announcements/safety-alert/isotretinoin-and-risk-of-psychiatric-disorders-and-sexual-dysfunction
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