June 22, 2018

FDA Warns Consumers About Adverse Events Associated with Limbrel, a Dietary Supplement

The FDA is alerting consumers about "potentially life-threatening health problems" linked to Limbrel, a dietary supplement that is marketed to "manage the metabolic processes associated with osteoarthritis." The company is not removing the product from the market. This product is marketed as a medical food, but the FDA's investigation determined that it is an unapproved new drug. And the FDA does not have mandatory recall authority over drug products. The FDA is reminding 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 health care provider. Health care providers who are aware that their patients are taking Limbrel should advise … [Read more...]

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