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and Welfare issued a public health warning regarding a possible association between Qing-Dai and the development of PAH.4 A subsequent Japanese national survey in 2017– 2018 revealed that 1.8% of patients with UC were using Qing-Dai, and that the adverse effects experienced included, in order of frequency, liver dysfunction, gastrointestinal symptoms, headache, PAH, and intussusception, although no dose–effect relationship between Qing-Dai and these adverse events was identified.5 Based on the results of those reports, Qing-Dai was added to the list of drugs and toxins possibly associated with PAH at the 6th World Symposium on Pulmonary Hypertension in 2018.6 Several mechanisms have been proposed for the development of PAH associated with Qing-Dai use: (1) indigo Q ing-Dai is a Chinese herbal medicine containing indigo naturalis and indirubin, which are compounds derived from the stems and leaves of several plant species and most commonly used in the manufacture of blue dyes. In China, Qing-Dai is traditionally used to treat various inflammatory diseases.1 In Japan, although Qing-Dai is not currently approved by the Pharmaceuticals and Medical Devices Agency, it is sometimes used by patients at their own discretion for the treatment of ulcerative colitis (UC) that has not responded to standard evidence-based therapy. In 2016, the INDIGO Study Group initiated a clinical trial to verify the efficacy of Qing-Dai in patients with UC;2 however, the trial was terminated early because of a report that a patient with UC being treated with Qing-Dai developed pulmonary arterial hypertension (PAH).3 In response to that trial, on 27 December 2016, the Japanese Ministry of Health, Labour Article p ????

Risk of Pulmonary Arterial Hypertension During Qing-Dai Use for the Treatment of Ulcerative Colitis