A case of hepatotoxicity by Pelargonium sidoides

Pelargonium sidoides (PS) is an African herbaceous, perennial plant in the geranium family. The root is the part used medicinally for respiratory problems. Its pharmacological activities include moderate direct antibacterial and antiviral potencies and immunomodulatory capabilities. An alcohol extract made from PS has become popular in Germany as a treatment for various respiratory problems, including acute bronchitis, common cold, sinusitis, pharyngitis and tonsillitis. The chemical composition of the PS is varied: sesquiterpenes are most abundant, coumarin and high quantity of tannins. In March 2011, a 46-year-old male patient was hospitalised. The patient suffered from epilepsy, oligophrenia, hypothyroidism, hypertension and a congenital heart disease. The patient had been on therapy with furosemide, acetylsalicylic acid, phenobarbital sodium, carbamazepine, olanzapine, valproate sodium, lansoprazole, allopurinol and canrenone for 10 years without any adverse effect. The blood tests performed about 15 days before hospital admission showed normal values (especially alanine transaminase (ALT), aspartate transaminase (AST) and bilirubin were in the normal range). Just before hospitalisation, the patient was treated with a remedy for a common cold: PS 30 drops three times a day, stopped after 6 days. In hospital the routine blood tests showed increased liver enzymes: ALT: 2385 IU I–1 (normal range: 1–45) and AST: 4072 IU I–1 (normal range: 1–36). After 3 days, blood tests showed a decrease of ALT: 1813 IU I–1 and AST: 1251 IU I–1. The patient died on the 4th day due to acute liver failure and respiratory distress related to the above comorbidities. The case was defined as ‘possible’ according to the objective causality assessment performed using Naranjo algorithm. Adverse drug reactions (ADRs) related to PS are quite rare in the published clinical trials and, generally, they were of mild severity and comparable with a placebo. The most frequent ADRs reported, due to PS, were gastrointestinal disorders, nervous system disorders and ear and labyrinth disorders; however, the presence of high concentrations of coumarins and tannins can cause liver toxicity. Recently, 15 cases of suspected hepatotoxicity induced by PS have been published, but they were evaluated as doubtful by the authors. This case underlines the importance of further studies to establish the association between PS and liver damage.