Reports Of Drug-Induced Liver Injury And Hypersensitivity Pneumonitis Are At Center Of This Unusual Drug Safety Controversy
UPDATE: Primus Pharmaceuticals Inc. Finally Removes Its Osteoarthritis Capsule Limbrel From The Market
... "We are not shipping. We're not promoting. We're not sampling doctors," said Primus President and CEO James Weir. "We have terminated all of those activities in good faith even though we don't believe our product is life threatening."
Primus sells Limbrel as a "medical food," but the FDA said last month that the product is an unapproved drug linked to 194 adverse events over the last decade.
According to the "What is Limbrel?" page of the Limbrel.com website (accessed 12/8/17) which is presented by Primus Pharmaceuticals, Inc.:
Limbrel contains flavocoxid, a proprietary blend of natural ingredients from phytochemical food source materials. Flavocoxid is comprised primarily of the flavonoids such as baicalin and catechin.
From the "FDA Limbrel Alert" page of the Limbrel.com website (accessed 12/8/17):
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.
We first reported about the November 21, 2017 FDA warning about Limbrel last month in this post, "Osteoarthritis 'Medical Food' Limbrel Tied to Life-Threatening Events".
Since then there was this December 4, 2017 FDA statement:
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.
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More information about the apparent stand-off between the FDA and Primus Pharmaceuticals can be found on that same web page, "FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel", which includes these three points in the "Fast Facts" section:
- The FDA continues to investigate a rise in reports of serious adverse events, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis, involving Limbrel, a product in capsule form currently marketed to “manage the metabolic processes associated with osteoarthritis.”
- On November 30, 2017, the FDA reiterated to Primus Pharmaceuticals the agency’s safety concerns and serious health risks associated with continued use of the product. The FDA recommended a voluntary recall, but so far the company has declined to take the product off the market.
- The FDA is advising consumers not to use any Limbrel products because of the risk of drug-induced liver injury and a lung condition called hypersensitivity pneumonitis. If you are taking this product, discontinue it immediately and contact your health care provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.
On that same FDA page, the next section, "What is the Problem and What is Being Done About It?", provides 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.
We will continue to follow this developing drug safety issue. Further, we welcome anyone with insights to the Limbrel situation to post their information in a Comment below or share it with us privately by sending me an email.
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