Other safety alerts
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| The United States: Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to potentially life-threatening health problems |
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The US Food and Drug Administration (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. 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.
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.
On 8 Nov 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm586111.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Nov 22, 2017
Issued at HKT 15:00
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