Hepatitis Caused by Lotus‐f3?

Abstract

We present a case of hepatitis and jaundice are associated with ingestion of Lotus-f3 submitted to our regional pharmacovigilance centre. A 56-year-old woman with psoriatic arthritis developed increased liver enzymes and jaundice 3 weeks after having started to take the product. The woman had been treated with etanercept for more than a year. She was hospitalized with hepatitis, and viral causes were ruled out. Liver biopsy suggested autoimmune or toxic hepatitis. Both etanercept and Lotus-f3 were withdrawn, and 6 weeks later the liver enzymes were normalized without any treatment. Etanercept was subsequently successfully reintroduced, and based on the rapid resolution of the hepatitis, a toxic effect of Lotus-f3 was suggested. This was the first report in the national adverse drug reaction database for this product, but three similar cases have now been reported. Lotus-f3 contains an extract of green tea, which has been associated with hepatotoxicity. The Norwegian adverse drug reaction database contains nine reports of hepatitis or jaundice associated with natural products. Four different natural products containing extracts of green tea have been suspected in eight out of these nine reports.Natural products are often marketed as safe. However, both national and international reports show that natural products can cause serious adverse reactions including hepatotoxicity [1][2][3]. Female gender seems to be a risk factor for adverse hepatic reactions [3]. Development of liver disease can be due to the claimed constituents, pesticides, residues from the production processes, contamination or added drugs. Lotus-f3 is marketed as a weight-reducing product, and contains extracts of the five herbals, Lotus arabicus , Citrus aurentium , Camellia sinensis , Fraxinus excelsior , Betula pendula , and chrome. A complete list of constituents and extractions are listed in table 1, as described by the producer (Faun Pharma AS, Drøbak, Norway). The Regional Drug Information Centres in Norway (RELIS) have the responsibility for regional pharmacovigilance based on a spontaneous adverse drug reaction reporting system. The present report was submitted to RELIS in 2006 where acute hepatitis was associated with ingestion of Lotus-f3. The presentation of the case follows the guidelines for submitting adverse event reports for publication [4]. Materials and methodsCase report. A 56-year-old woman with a history of psoriatic arthritis for about 10 years, otherwise healthy, was treated with Enbrel ® (etanercept) 25 mg injection once a week for more than a year. She used no other drugs. Two weeks before the incident Enbrel was increased from 25 to 50 mg weekly. In the last weeks before admission to hospital she gradually developed cough, nausea, and fever. Her appetite was good, but her weight had been slightly reduced by 3 kg. Because of abdominal pain, nausea, vomiting, and diarrhoea she consulted her family physician. Jaundice and increased liver enzymes were diagnosed, and she was admitted to hospital. In addition to Enbr...

Hepatotoxicity of green tea: an update

“…The case 17 (Bergman and Schjøtt 2009) involved a 55-year-old man with a history of psoriatic arthritis who took Lotus-f3 ® . This is the unique published report of hepatotoxicity from this supplement; however, other unpublished cases are reported in Norwegian Adverse Drug Reaction database (RELIS) (http://relis.arnett.no/Utredning_Ekstern.aspx?Relis=3&S=4390&R=X).…”

Norwegian drug information centres strongly promote person-centred and personalised medicine: a brief report on the achievements and strategy

“…biomarkers, pharmacogenetics and drug concentrations) in the context of pharmacotherapy are common. Cases concerning suspected traditional, complementary and alternative medicine (TCAM)-induced or drug-induced liver injury (DILI) in patients with elevated alanine aminotransferase (ALT) and elevated alkaline phosphatase (ALP) are frequent [28,29]. In our answers, the relevance of the laboratory values is explained to a clinician motivated to solve a problem, and RELIS suggest further diagnostic steps to verify a DILI (e.g.…”

Liver Illness and Psoriatic Patients

“…A case of hepatitis and jaundice is associated with ingestion of Lotus-f3 submitted to a Norwegian regional pharmacovigilance center. A 56-year-old woman with PsA developed increased liver enzymes and jaundice 3 weeks after having started to take the product [ 29 ]. Table 1 shows comparison of liver toxic substances in psoriatic patients [ 7 , 13 , 16 , 22 , 23 , 25 – 28 , 30 – 32 ].…”