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) has recommended that Primus Pharmaceuticals, Scottsdale, Arizona, voluntarily recall Limbrel, a capsule marketed to “manage the metabolic processes associated with osteoarthritis.” The company has not yet acted to remove the product from the market. This advisory on 5 Dec 2017 is an update of the advisory on 21 Nov 2017.
Although the product is marketed as a medical food, the preliminary determination of the FDA investigation is that Limbrel is an unapproved new drug. The agency does not have mandatory recall authority over drug products.
The FDA reminds consumers not to use Limbrel because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking this product should stop immediately and contact their healthcare provider. Healthcare providers who are aware that their patients are taking Limbrel should advise them to stop using it.
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. Related news was previously issued by FDA, and was posted on the Drug Office website on 22 Nov 2017.
Ends/Wednesday, Dec 6, 2017
Issued at HKT 17:00
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