On November 21, 2017 the FDA issued this Safety Alert for Human Medical Products: “Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory – Linked to Potentially Life-Threatening Health Problems”.
More recently, there was a December 4, 2017 FDA statement which can be found on this Safety Alerts & Advisories page, “FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel”:
The U.S. Food and Drug Administration 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. 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 any Limbrel products because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking any Limbrel products should stop immediately and contact their health care provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.
Primus Pharmaceuticals, Inc. is the company responsible for Limbrel.
From the “FDA Limbrel Alert” page of the Limbrel.com website (accessed 12/8/17) presented by Primus:
Limbrel has not been recalled though the FDA has asked Primus to make a voluntary recall. Primus is waiting to obtain the documents on which FDA has based its safety alert and recall request prior to making a final decision, although the opinions of independent experts and the medical literature conflict with FDA’s safety alert and request for recall.
Returning to the FDA Safety Alerts & Advisories page, under the section, “What is the Problem and What is Being Done About It?”, there is some additional information about this unfolding Limbrel situation:
On November 8, 2017, the FDA first contacted Primus Pharmaceuticals regarding the adverse events and requested information about the formula for Limbrel. The formula is being reviewed by the FDA. The FDA also obtained product samples from the company and the samples are undergoing testing.
The FDA continues to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.
Be assured we will continue to follow this developing drug safety issue.
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