英国药监局为抗抑郁药推出新安全措施：说明书加框警告、新发患者卡，部分药物标示停药后性功能障碍
英国药品与保健品监管局（MHRA）10月在伦敦公布，在一项有患者与家属参与的检视之后，英国为所有抗抑郁药患者推出新的安全措施：患者说明书将加入新的框线警告，当局将新发一张患者卡及一份配套安全单张（2027年提供），部分抗抑郁药的说明书将加入「停药后性功能障碍」（PSSD）这一术语。
MHRA 表示，医疗专业人员应在治疗开始及剂量调整等时点，与患者商讨自杀念头与行为的风险，以及停药后仍可能持续的性功能障碍风险。患者如出现紧急情况，应立即求助，可致电 NHS 111、撒玛利亚会 116 123，或发送短信「SHOUT」至 85258。
MHRA 强调，上述风险并非新发现，措施旨在确保患者在开始服用抗抑郁药之前充分知情。当局提醒患者切勿在没有专业意见的情况下自行停药，突然停药可能带来风险；任何疑似不良反应可通过黄卡系统报告。
这些措施载于 MHRA 10月《安全通讯》同期的药物安全更新，适用于英国境内所有抗抑郁药产品。
UK Regulator Adds Antidepressant Safety Measures: Boxed Leaflet Warnings, New Patient Card and PSSD Labelling
The UK Medicines and Healthcare products Regulatory Agency (MHRA) announced in London in October that, following a review involving patients and families, new safety measures are being introduced for all antidepressant patients in the UK. Patient information leaflets will carry a new boxed warning, supported by a new patient card and an ancillary safety leaflet, available in 2027, and the term post-SSRI sexual dysfunction (PSSD) will be added to the leaflets of some antidepressants.
The MHRA said healthcare professionals should discuss with patients the risks of suicidal thoughts and behaviours and of sexual dysfunction that may persist after stopping treatment, particularly when starting treatment or changing dose. Patients who need urgent help are advised to contact NHS 111, call the Samaritans on 116 123, or text 'SHOUT' to 85258.
The agency stressed that the risks are not new; the measures are intended to make sure patients are fully informed before they start an antidepressant. Patients are reminded not to stop their medication without professional advice, as stopping suddenly can itself cause problems. Any suspected side effects can be reported through the Yellow Card scheme.
The measures are set out in a Drug Safety Update published in the MHRA's October Safety Roundup and apply to all antidepressant products in the UK.
来源：GSM·美国（原文链接）
图片来源：手持泡罩包装的药片（资料图）。Shixart1985 摄，CC BY 2.0，经 Wikimedia Commons。 / A person holds a blister pack of pills (file photo). Photo by Shixart1985, CC BY 2.0, via Wikimedia Commons.
