On December 5, 2017, the Federal Drug Administration (FDA) recommended that Limbrel capsules, intended for the treatment of osteoarthritis, be recalled. The FDA advisory concerning Limbrel, which is manufactured by Primus Pharmaceuticals, stated that the product has been connected to incidents of liver injury and other serious health issues. The agency recommended that consumers immediately stop taking the product it deems as a dangerous drug and get in touch with their healthcare provider.
Primus Pharmaceuticals markets the product as a medical food. However, in a letter to the President and Chief Executive Officer of Primus, James D. Weir, the FDA wrote “The FDA has determined that these Limbrel products are unapproved new drugs and represent a serious health hazard.”
What is Limbrel?
Limbrel (flavocoxid), at least as defined by its manufacturer, is a “medical food product” consisting of substances derived from plant sources called “flavonoids.” Some Limbrel products contain zinc glycinate. These products come in the form of capsules that can be taken daily. The manufacturer claims that the product reduces inflammation, which in turn reduces pain and swelling.
Reports of Lung and Liver Disease
As of November 21, 2017, the FDA had received 194 bad incident reports connected with the products. These reports led to the conclusion by the FDA that the use of Limbrel is connected to such illnesses and diseases as pancreatitis, drug induced liver injury, and hypersensitivity pneumonitis. The number of adverse reports increased to 200 by December 4, 2017.
The nature of some of these conditions, which makes them even more dangerous and difficult to address promptly, is that they may not become noticeable immediately. Symptoms may only manifest at the point when hospitalization is required.
In response to the FDA’s actions, on December 21, 2017, Primus Pharmaceuticals ceased all promotion and sale of its Limbrel products.
Limbrel as a “Medical Food Product”
In 2004, Limbrel was approved for the treatment of chronic osteoarthritis. Although the product contains ingredients that are derived from plants, it is only available to patients through a valid prescription.
The definition of a “medical food” is a product that is intended to be taken under the supervision and direction of the physician.
The Orphan Drug Act stipulates that medical food products are designed for the “dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
Medical food products are designed for purposes of treating a medical condition, rather than to simply enhance the health of already healthy individuals. These products do not require the pre-marketing study of their effectiveness and safety, as do drugs.
In the FDA’s letter to Primus, the agency not only urged the recall, but also asserted that Limbrel was incorrectly branded and did not qualify under the definition of a medical food. The FDA also informed the company that it was “not aware of any distinctive nutritional requirements for individuals with osteoarthritis.”
If you or a loved one has suffered distinct harm from any dangerous drug or medical food product, our dangerous drug attorneys at Crandall & Pera Law can help. We can fight vigorously on your behalf to help you secure justice and the compensation to which you are entitled. To set up a free consultation with an experienced attorney from our team, complete our contact form or call our Kentucky office at 877.686.8879, or our Ohio office at 877.651.7764.