Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems
[Posted 11/21/2017]
AUDIENCE: Consumer, Health Professional
ISSUE: The FDA is investigating serious adverse events involving Limbrel, a product in capsule form currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. While a range of adverse events have been reported, two serious and potentially life-threatening medical conditions are among them: drug-induced liver injury and hypersensitivity pneumonitis. In total, the FDA has received 194 adverse event reports regarding Limbrel, of those, 57 of the cases contained sufficient information to analyze in detail whether Limbrel was associated with an adverse event; 30 of these contained sufficient information to use the Council for International Organizations of Medical Sciences (CIOMS) causality assessment method to determine the likelihood that an association between the consumption of Limbrel and the adverse events reported exists.
BACKGROUND: Limbrel is marketed by Primus Pharmaceuticals Inc., Scottsdale, AZ. Limbrel is available in capsule form in two dosages: Limbrel250 and Limbrel500. The labeling states that the products contain two types of flavonoids: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu). Both dosages also contain zinc. Claims made on the product label and in labeling indicate that Limbrel is intended to manage the metabolic processes associated with osteoarthritis.
On November 8, 2017, the FDA contacted Primus Pharmaceuticals regarding the adverse events and requested information about the formula for Limbrel. The formula is being reviewed by the FDA. In the interim, the agency is alerting consumers and health care providers about the potential impact to health and advising consumers not to use Limbrel.
The FDA is continuing to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.
RECOMMENDATION:
‧ For Consumers: If you are taking Limbrel, immediately stop taking it and contact your health care provider. If you have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, work with your health care provider to report your symptoms to the FDA through MedWatch.
‧ For Health Professionals: Health care providers who are aware that their patients are taking Limbrel should advise them to immediately stop taking the product. If your patients have experienced any of the above-mentioned symptoms or other health problems while taking Limbrel, the FDA encourages you to work with them to provide clinical information through MedWatch.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586111.htm
Limbrel膠囊為一美國剛上市之健康食品，用以調控跟骨關節炎相關之代謝過程，其有兩種含量：250 mg/cap與500 mg/cap，該產品包含兩種類黃酮(flavonoids): 黃芩?(baicalin)（來源為:Scutellaria baicalensis）以及兒茶素catechin（來源為：Acacia catechu）以及鋅。
美國FDA共收到194起關於Limbrel膠囊之不良反應事件通報，其中有兩個嚴重且危及生命的不良反應為：藥物相關的肝損傷以及過敏性肺炎，因而發布相關安全警訊。
2017年11月美國FDA根據這些不良反應通報，要求廠商提供關於Limbrel產品之配方及製程資料。在美國FDA審查及回顧文獻期間，由於此產品對於健康之潛在風險尚在評估中，提醒消費者與醫療專業人員注意相關副作用，並建議消費者勿使用此產品。如有更進一步消息會再發布相關資訊。建議：
(1)消費者：如正在使用Limbrel，請立即停藥並與醫療專業人員聯繫，如使用Limbrel有出現肝臟或肺部相關副作用，請立即告知醫療專業人員。
(2)醫療專業人員：如得知病人正在服用此藥，請立即建議病人停藥。如病人使用此藥出現相關副作用，請提供病人相關資訊且通報FDA。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586111.htm
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
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