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Tea tree (Melaleuca alternifolia) essential oil is widely used as an antiseptic. It mainly consists of monoterpenes with terpinen‐4‐ol as the major constituent. The aim of this study was to review literature on safety data about tea tree oil and to assess its safety by investigating 159 cases of adverse reactions possibly caused by the oil, reported to the World Health Organization (WHO) from December 1987 until September 2021. To extract these data, VigiBase, the WHO global database of individual case safety reports maintained by the Uppsala Monitoring Centre (UMC), was used. All cases were categorized and analysed and 16 serious cases further assessed. It was concluded that tea tree oil should never be administered orally, as it can lead to central nervous system depression and pneumonitis. Applied topically, skin disorders may occur, especially when the oil had been exposed to light or air. This yields monoterpene oxidation products, being potent skin irritants. Tea tree oil stored under appropriate conditions and not exceeding the expiration date should be considered safe to use by non‐vulnerable people for non‐serious inflammatory skin conditions, although the occurrence of adverse reactions such as contact allergies is difficult to predict. [ABSTRACT FROM AUTHOR]

Serious concerns are expressed on the safe use of red yeast rice (RYR) supplements. The aim of the present study was to analyse cases received by Lareb on RYR‐related adverse health events. These cases were analysed for the number of reports, number of adverse drug reactions (ADRs), causality, seriousness of the reaction, latency‐period, age and sex of the patients, concomitant medication and type of reporter. A total of 94 individual reports were collected by Lareb, corresponding with 187 ADRs. The analysis showed most reported ADRs were labelled musculoskeletal and connective tissue disorders (n = 64), gastrointestinal disorders (n = 33) and general disorders and administration site conditions (n = 23). The use of RYR supplements should be considered as a significant safety concern. Exposure to monacolin K could lead to serious adverse effects. To fully assess the safety profile of RYR supplements, more research is necessary to compose a complete ADR profile of RYR supplements. [ABSTRACT FROM AUTHOR]

Introduction: In the literature, vitamin B6 has been linked to the development of polyneuropathy. Most often, these complaints were seen when taking high doses of vitamin B6 for a long time. Evidence as to whether a lower dosage range of vitamin B6 (< 50 mg/day) can also induce neuropathy is scarce.Objective: We aim to comprehensively describe the cases of neuropathy associated with vitamin B6 received by the Netherlands Pharmacovigilance Centre Lareb and to assess the case series concerning the use of vitamin B6 and neuropathic complaints.Methods: We describe the number and nature of the reported cases, including suspect product, dosage, duration of use, and vitamin B6 serum levels. In addition, we describe the causality for the individual cases (Naranjo Probability Scale) and for the entire case series (Bradford Hill criteria).Results: In total, 90 reports on products containing vitamin B6 included at least one adverse drug reaction in the standardized Medical Dictionary for Regulatory Activities (MedDRA®) query (SMQ; broad) 'peripheral neuropathy'. The amount of vitamin B6 in the products varied between 1.4 and 100 mg per tablet. The serum vitamin B6 level was known in 36 cases (88-4338 nmol/l), and the mean serum vitamin B6 level was 907 nmol/l. However, no statistical correlation between dosage and vitamin B6 blood levels was found.Discussion and Conclusion: Causality assessment of the case series of 90 reports to Lareb shows it is plausible for the vitamin B6 supplements to have caused complaints such as neuropathies. This is especially the case with higher dosages and prolonged use, but dosages < 50 mg/day also cannot be excluded. [ABSTRACT FROM AUTHOR]

Background: A large number of herbal preparations are offered on the internet. Some of these may contain substances not listed on the label. When these are illegal "regular" drugs, this can lead to serious side effects., Case Description: In January 2021, The Netherlands Pharmacovigilance Centre Lareb received 4 reports of side effects after using the herbal preparation Montalin® from Indonesia. Laboratory analysis showed that effective amounts of paracetamol and meloxicam were also present in this herbal preparation. These have been added illegally and are not listed on the packaging. The five web shops that sold this product were ordered to immediately stop trading by order of the Dutch Food and Consumer Product Safety Authority (NVWA)., Conclusion: Consumers should be careful when purchasing herbal preparations over the internet. It is not always clear what is in it. Certainly if a clear effect is experienced, it may be that (illegally) effective amounts of pharmacologically active substances have been added.

Introduction: In the literature, vitamin B 6 has been linked to the development of polyneuropathy. Most often, these complaints were seen when taking high doses of vitamin B 6 for a long time. Evidence as to whether a lower dosage range of vitamin B 6 (< 50 mg/day) can also induce neuropathy is scarce., Objective: We aim to comprehensively describe the cases of neuropathy associated with vitamin B 6 received by the Netherlands Pharmacovigilance Centre Lareb and to assess the case series concerning the use of vitamin B 6 and neuropathic complaints., Methods: We describe the number and nature of the reported cases, including suspect product, dosage, duration of use, and vitamin B 6 serum levels. In addition, we describe the causality for the individual cases (Naranjo Probability Scale) and for the entire case series (Bradford Hill criteria)., Results: In total, 90 reports on products containing vitamin B 6 included at least one adverse drug reaction in the standardized Medical Dictionary for Regulatory Activities (MedDRA ® ) query (SMQ; broad) 'peripheral neuropathy'. The amount of vitamin B 6 in the products varied between 1.4 and 100 mg per tablet. The serum vitamin B 6 level was known in 36 cases (88-4338 nmol/l), and the mean serum vitamin B 6 level was 907 nmol/l. However, no statistical correlation between dosage and vitamin B 6 blood levels was found., Discussion and Conclusion: Causality assessment of the case series of 90 reports to Lareb shows it is plausible for the vitamin B 6 supplements to have caused complaints such as neuropathies. This is especially the case with higher dosages and prolonged use, but dosages < 50 mg/day also cannot be excluded.