Suspected Hepatotoxicity With a Supercritical Carbon Dioxide Extract of Artemisia annua in Grapeseed Oil Used in New Zealand
A case series of hepatotoxicity associated with an extract of Artemisia annua L. was identified through the New Zealand spontaneous adverse drug reaction reporting system. A. annua extract, produced using a supercritical carbon dioxide extraction method and formulated with grapeseed oil, has been ma...
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Frontiers Media S.A.
2019-12-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fphar.2019.01448/full |
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| author | Ruth L. Savage Ruth L. Savage Geraldine R. Hill Joanne Barnes Susan H. Kenyon Michael V. Tatley |
| author_facet | Ruth L. Savage Ruth L. Savage Geraldine R. Hill Joanne Barnes Susan H. Kenyon Michael V. Tatley |
| author_sort | Ruth L. Savage |
| collection | DOAJ |
| description | A case series of hepatotoxicity associated with an extract of Artemisia annua L. was identified through the New Zealand spontaneous adverse drug reaction reporting system. A. annua 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 A. annua extract in grapeseed oil. The case reports were assessed for patient and adverse reaction characteristics, patterns of A. annua 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 A. annua extract was 7 days to approximately 12 months in the 23 reports with this information. Nineteen of these reports indicated onset within 12 weeks. A. annua 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 A. annua 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 A. annua extract and hepatotoxicity sufficient to be communicated and investigated further. |
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| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-04-12T21:38:02Z |
| publishDate | 2019-12-01 |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-95dab8719c364a6295dda88e90d23ae22022-12-22T03:15:51ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122019-12-011010.3389/fphar.2019.01448489651Suspected Hepatotoxicity With a Supercritical Carbon Dioxide Extract of Artemisia annua in Grapeseed Oil Used in New ZealandRuth L. Savage0Ruth L. Savage1Geraldine R. Hill2Joanne Barnes3Susan H. Kenyon4Michael V. Tatley5New Zealand Pharmacovigilance Centre, Dunedin School of Medicine, University of Otago, Dunedin, New ZealandDepartment of General Practice, University of Otago, Christchurch, New ZealandMedsafe, Ministry of Health, Wellington, New ZealandSchool of Pharmacy, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New ZealandMedsafe, Ministry of Health, Wellington, New ZealandNew Zealand Pharmacovigilance Centre, Dunedin School of Medicine, University of Otago, Dunedin, New ZealandA case series of hepatotoxicity associated with an extract of Artemisia annua L. was identified through the New Zealand spontaneous adverse drug reaction reporting system. A. annua 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 A. annua extract in grapeseed oil. The case reports were assessed for patient and adverse reaction characteristics, patterns of A. annua 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 A. annua extract was 7 days to approximately 12 months in the 23 reports with this information. Nineteen of these reports indicated onset within 12 weeks. A. annua 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 A. annua 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 A. annua extract and hepatotoxicity sufficient to be communicated and investigated further.https://www.frontiersin.org/article/10.3389/fphar.2019.01448/fullArtemisia annuaherb-induced liver injury (HILI)herbal medicinespharmacovigilanceadverse reaction reporting |
| spellingShingle | Ruth L. Savage Ruth L. Savage Geraldine R. Hill Joanne Barnes Susan H. Kenyon Michael V. Tatley Suspected Hepatotoxicity With a Supercritical Carbon Dioxide Extract of Artemisia annua in Grapeseed Oil Used in New Zealand Frontiers in Pharmacology Artemisia annua herb-induced liver injury (HILI) herbal medicines pharmacovigilance adverse reaction reporting |
| title | Suspected Hepatotoxicity With a Supercritical Carbon Dioxide Extract of Artemisia annua in Grapeseed Oil Used in New Zealand |
| title_full | Suspected Hepatotoxicity With a Supercritical Carbon Dioxide Extract of Artemisia annua in Grapeseed Oil Used in New Zealand |
| title_fullStr | Suspected Hepatotoxicity With a Supercritical Carbon Dioxide Extract of Artemisia annua in Grapeseed Oil Used in New Zealand |
| title_full_unstemmed | Suspected Hepatotoxicity With a Supercritical Carbon Dioxide Extract of Artemisia annua in Grapeseed Oil Used in New Zealand |
| title_short | Suspected Hepatotoxicity With a Supercritical Carbon Dioxide Extract of Artemisia annua in Grapeseed Oil Used in New Zealand |
| title_sort | suspected hepatotoxicity with a supercritical carbon dioxide extract of artemisia annua in grapeseed oil used in new zealand |
| topic | Artemisia annua herb-induced liver injury (HILI) herbal medicines pharmacovigilance adverse reaction reporting |
| url | https://www.frontiersin.org/article/10.3389/fphar.2019.01448/full |
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