Limbrel capsules linked with serious AEs in the US

Limbrel capsules linked with serious AEs in the US Reactions 1680, p3 - 2 Dec 2017 Limbrel capsules linked with serious AEs in the US The US FDA is advising consumers not to use the flavonoid-containing capsules (Limbrel) while the products are under investigation due to the risk of serious adverse events (AEs). In the US, Limbrel capsules are marketed by Primus Pharmaceuticals as a medical food to manage the metabolic processes associated with osteoarthritis. The products are available in two dosages (as Limbrel250 and Limbrel500) and contain two types of flavonoids: baicalin (from Scutellaria baicalensis; a species of flowering plant also known as Chinese skullcap) and catechin (from Acacia catechu – an extract of acacia trees that is used as a food additive, astringent, tannin, and dye). While a range of AEs have been reported with these products, "two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis", noted the FDA. In total, the agency has received a total of 194 Limbrel- associated AEs, of which there was sufficient information in 57 cases to determine if Limbrel was associated with the reported AE. In 30 of those cases, there was sufficient information for FDA medical experts to determine that Limbrel was likely associated with these AEs. The agency is continuing to investigate Primus Pharmaceuticals and the Limbrel manufacturing processes, and further information regarding Limbrel- related AEs and the product formulation have been requested. In the meantime, people consuming this product are advised to immediately stop taking it and contact their doctor. Both consumers and healthcare professionals are also encouraged to report any AEs associated with the Limbrel products via the FDA’s MedWatch programme. US Food and Drug Administration. Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems. Internet Document : 21 Nov 2017. Available from: URL: https://www.fda.gov/Safety/ MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ ucm586111.htm 803285959 0114-9954/17/1680-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 2 Dec 2017 No. 1680 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Reactions Weekly Springer Journals

Limbrel capsules linked with serious AEs in the US

Reactions Weekly , Volume 1680 (1) – Dec 2, 2017
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Publisher
Springer Journals
Copyright
Copyright © 2017 by Springer International Publishing AG, part of Springer Nature
Subject
Medicine & Public Health; Drug Safety and Pharmacovigilance; Pharmacology/Toxicology
ISSN
0114-9954
eISSN
1179-2051
D.O.I.
10.1007/s40278-017-38934-6
Publisher site
See Article on Publisher Site

Abstract

Reactions 1680, p3 - 2 Dec 2017 Limbrel capsules linked with serious AEs in the US The US FDA is advising consumers not to use the flavonoid-containing capsules (Limbrel) while the products are under investigation due to the risk of serious adverse events (AEs). In the US, Limbrel capsules are marketed by Primus Pharmaceuticals as a medical food to manage the metabolic processes associated with osteoarthritis. The products are available in two dosages (as Limbrel250 and Limbrel500) and contain two types of flavonoids: baicalin (from Scutellaria baicalensis; a species of flowering plant also known as Chinese skullcap) and catechin (from Acacia catechu – an extract of acacia trees that is used as a food additive, astringent, tannin, and dye). While a range of AEs have been reported with these products, "two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis", noted the FDA. In total, the agency has received a total of 194 Limbrel- associated AEs, of which there was sufficient information in 57 cases to determine if Limbrel was associated with the reported AE. In 30 of those cases, there was sufficient information for FDA medical experts to determine that Limbrel was likely associated with these AEs. The agency is continuing to investigate Primus Pharmaceuticals and the Limbrel manufacturing processes, and further information regarding Limbrel- related AEs and the product formulation have been requested. In the meantime, people consuming this product are advised to immediately stop taking it and contact their doctor. Both consumers and healthcare professionals are also encouraged to report any AEs associated with the Limbrel products via the FDA’s MedWatch programme. US Food and Drug Administration. Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems. Internet Document : 21 Nov 2017. Available from: URL: https://www.fda.gov/Safety/ MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ ucm586111.htm 803285959 0114-9954/17/1680-0001/$14.95 Adis © 2017 Springer International Publishing AG. All rights reserved Reactions 2 Dec 2017 No. 1680

Journal

Reactions WeeklySpringer Journals

Published: Dec 2, 2017

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