
食藥署要求藥廠研提風險評估及管控計畫,提醒民眾勿自行購買施打
食藥署統計,今年接獲63件疑似使用GLP-1受體促效劑類藥品的不良反應通報,其中39件為減重用途、24件為糖尿病治療用途,症狀以腸胃疾病居多。食藥署已要求藥廠研提上市後安全性研究計畫書及風險評估及管控計畫,並提醒民眾該類注射劑為醫師處方藥,切勿自行購買施打。
AI-generated summary
俗稱「瘦瘦針」的腸泌素藥物是糖尿病患者控制血糖的重要藥物,同時也因為調節食慾、延緩胃排空速度,被許多民眾視為減重救星。近年來這類藥物也被應用於體重管理,使用人數增加。
俗稱「瘦瘦針」的腸泌素藥物是糖尿病患者控制血糖的重要藥物,同時也因為調節食慾、延緩胃排空速度,被許多民眾視為減重救星。但隨著使用人數增加,瘦瘦針副作用也引起關注,食藥署統計,今年已接獲六十三件疑似使用GLP-1受體促效劑類藥品的不良反應,其中超過六成是用於減重用途,通報症狀樣態則以腸胃疾病居多。
「瘦瘦針」是民眾對於部分減重及血糖控制針劑藥物的俗稱,近年來大多是指GLP-1受體促效劑及GLP-1/GIP受體促效劑等腸泌素相關藥物,這類藥物可模擬人體賀爾蒙作用,產生抑制食慾、幫助血糖控制等效果,本來是作為糖尿病治療用藥,但近年來也被應用於體重管理。
食藥署藥品組簡任技正劉佳萍表示,今年全國藥物不良反應通報系統接獲的GLP-1受體促效劑類藥品相關不良反應通報中,卅九件為減重用途、廿四件為糖尿病治療用途,通報症狀如腸胃疾病(含腹痛、腸阻塞、胰臟炎)、低血糖、噁心、嘔吐、注射部位不適等。
由於瘦瘦針使用人數增加,且使用者從糖尿病擴及一般民眾,食藥署已要求藥廠提供病人用藥安全指引,載明急性腎損傷、視神經病變等可能風險。劉佳萍也提到,食藥署已函請廠商研提上市後安全性研究(PASS)計畫書及制定風險評估及管控計畫(RMP),並持續監測國內外藥品安全資訊,蒐集彙整相關資料進行評估,對新增的藥品風險採取對應風險管控措施。
食藥署提醒,GLP-1受體促效劑注射劑屬醫師處方藥,民眾應經醫師診察及專業評估後,依處方及醫囑使用,切勿透過非正規管道購買或自行施打,以免因使用不當或藥品來源不明而危害健康;用藥期間如發生藥品不良反應,應立即尋求醫療協助,若醫療人員或病人懷疑因使用藥品造成不良反應,請立即通報全國藥物不良反應通報中心。
AI outlook — possibilities, not facts
食藥署將根據藥廠研提的PASS計畫書及RMP,對GLP-1受體促效劑類藥品採取對應的風險管控措施。
Likely · Within months

Cai Zhengyan, a urologist at China Medical University Hsinchu Hospital, explained that injecting biocompatible hydrogel filling material into the urethral wall through an endoscope can increase the closing force of the urethra. The treatment only takes about 20 minutes, and the patient is discharged the next day. It is suitable for patients with stress urinary incontinence.

In response to the problem of elderly people with dementia who refuse to eat, Xinying Hospital promotes "hand-held meals" to design meals into small portions that are easy to take and preserve the dignity of the elderly's independent eating. Doctors pointed out that food refusal may be related to forgetting eating steps, difficulty in operating tableware, depression and suicide risk, and requires integrated care from neurology, psychiatry, nursing, nutrition and swallowing rehabilitation teams.

Chen Baiyue, a gastrointestinal and hepatobiliary physician at Chiayi Christian Hospital, pointed out that dual immunotherapy has been included in health insurance benefits as one of the treatment options for advanced liver cancer. By combining two immune checkpoint inhibitors to activate the autoimmune system, about 20% of patients can have their tumors significantly shrunk or even reversed to the stage of surgical resection, and are less likely to suffer side effects of liver damage.

The Diabetes Health Education Society plans to invite domestic societies to jointly publish Asia's first special guidelines on the side effects of slimming injections with Japan, South Korea and other Asian countries. The first draft is expected to be drafted by the end of November and published in international academic journals in January next year. The content covers situations such as drug withdrawal before surgery, dose conversion and overdose management.

The Taiwan Diabetes Education Association plans to work with domestic and regional partners to develop Asia's first GLP-1 drug side effect prevention and management guidelines, covering safe use in weight loss and diabetes management, which are expected to be published in international academic journals in January next year. Taiwan's Food and Drug Administration has received 63 reports of suspected adverse reactions involving GLP-1 receptor agonists this year, mainly gastrointestinal problems.

A study led by Queen Mary, University of London found that after the new drug baxdrostat was used to treat patients with primary aldosteronism, some patients' blood pressure returned to normal after stopping the drug for up to two years, which is expected to "cure" hypertension. The findings were published in the New England Journal of Medicine and NICE is assessing whether the drug should be made available on the NHS.