Andrographis paniculata is a herbal ingredient found in non-prescription products. Nearly 100 products are currently listed on the Australian Register of Therapeutic Goods, 12 of which were newly registered in 2024.1 Despite accumulating reports of allergic reactions to Andrographis,2, 3 access remains unrestricted. We report the clinical features of patients diagnosed with hypersensitivity reactions to products containing Andrographis paniculata at a tertiary Victorian allergy service. Cases at the Alfred Hospital were identified by the treating allergist between July 2008 and November 2024. Ethics approval was obtained from The Alfred Human Research and Ethics Committee HREC 494/24. In total, 24 patients with hypersensitivity reactions to Andrographis were identified (Table 1). No alternate culprits or cofactors were found. Median age was 37.5 years (range: 22–77), Australasian Society of Clinical Immunology and Allergy and 62.5% were female. The prevalence of allergic rhinitis (25%) and food allergy (8.3%) was comparable to national data from 2022, but we observed a higher prevalence of asthma (25%).4 Anaphylaxis criteria5, 6 were met in all cases. Using Australasian Society of Clinical Immunology and Allergy drug allergy definitions,7 most reactions were immediate (75%). Symptom onset was unreported (8%) or delayed to 12–48 h (17%) in the remaining cases. Multiple reactions were reported by 12 patients. By Brown criteria, reactions were severe (45.8%), moderate (41.7%) and mild (12.5%).8 The commonest manifestations were rash (91%), hypotension (82%) and gastrointestinal symptoms (82%). All severe reactions featured either pre-syncope (45.5%) or syncope (54.5%). Intramuscular adrenaline was administered in 70.8% of cases, 29.4% of which received multiple doses. Acute tryptase was sampled in 82% of severe, 60% of moderate and 0% of mild reactions. Acute tryptase was elevated (>11.4 μg/L) in 67% of severe and 50% of moderate reactions. Cases with acute tryptases within normal range did not yield a significant delta, defined as 1.2 × (baseline tryptase) + 2.9 This is the first case series in Australia of Andrographis paniculata-associated hypersensitivity reactions. Our data reinforce the risk of allergy from Andrographis, with a skew towards moderate to severe reactions (87.5%). Over 300 reports of allergic reactions to Andrographis paniculata have been made since 2005. Over 200 arose after 2019, following the introduction of mandatory warning labels by the Therapeutic Goods Administration (TGA). This trend was reflected in our cohort with 80% of incidents after 2019. This finding supports that labels increase awareness. However, labels are also easily overlooked, as evidenced by the 12 cases of re-exposure described. Given the increasing reports of allergic reactions to Andrographis and the lack of robust evidence to support efficacy, access should be more tightly regulated. This case series has several limitations. First, data were obtained retrospectively from patient records, risking recall bias. Second, all products contained multiple ingredients, and confirmation of the culprit is currently impossible in the absence of validated tests. However, causality to the preparation was considered confirmed in the 12 patients with multiple reactions. Two patients underwent skin prick testing using a slurry, of which one was positive. The gold-standard diagnostic test of a supervised challenge was not pursued due to the risk of harm, in accordance with the ethical principle of non-maleficence. The data that support the findings of this study are available from the corresponding author upon reasonable request.
Giang et al. (Fri,) studied this question.