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Front Pharmacol


Suspected Hepatotoxicity With a Supercritical Carbon Dioxide Extract of in Grapeseed Oil Used in New Zealand.


Savage RL, Hill GR, Barnes J, Kenyon SH, Tatley MV
Front Pharmacol. 2019; 10:1448.
PMID: 31920644.


A case series of hepatotoxicity associated with an extract of L. was identified through the New Zealand spontaneous adverse drug reaction reporting system. extract, produced using a supercritical carbon dioxide extraction method and formulated with grapeseed oil, has been marketed in New Zealand as a natural product for joint health. As of 31 January 2019, the New Zealand Pharmacovigilance Centre had received 29 reports of hepatic adverse reactions occurring in patients taking extract in grapeseed oil. The case reports were assessed for patient and adverse reaction characteristics, patterns of extract use and causality (based on the WHO-UMC system for standardized case causality assessment). Patients were aged 47 to 93 years (median 67). Time to onset of hepatotoxicity from starting extract was 7 days to approximately 12 months in the 23 reports with this information. Nineteen of these reports indicated onset within 12 weeks. extract was the sole suspect medicine in 27 reports. A few patients had possible predisposing conditions. Twenty-seven patients were reported to have recovered or improved on stopping extract. Nine patients required hospital admission. The pattern of hepatic injury varied. Jaundice, often with pruritus and dark urine, was experienced by 16 patients. There was considerable consistency across case reports from various reporters. We assessed the case reports as a series using the Bradford Hill guidelines for causal inference and concluded that there was a safety signal of a causal association between the extract and hepatotoxicity sufficient to be communicated and investigated further.