Limbrel™ (flavocoxid™) is a “medical food” product made of substances from plant sources called falvonoids. It comes in capsule form with two doses – 250 mg and 500 mg – to be taken daily. Limbrel™ has been marketed and sold by Primus Pharmaceutical Inc. since 2004 as a nutritional supplement for “managing the metabolic processes associated with osteoarthritis,” and is available only by prescription. Osteoarthritis is a degenerative disease of the joints and is the most common form of arthritis. Primus Pharmaceuticals estimates that over the past 13 years it has sold approximately 2 million prescriptions and physician samples to an estimated 450,000 patients.
The term “medical food” is defined by section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)) as a food which is formulated to be consumed or administered under a doctor’s supervision which “is intended for the specific 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 that come within section 5(b) of the Orphan Drug Act do not require FDA approval.
On November 8, 2017, the FDA contacted Primus Pharmaceuticals regarding adverse events associated with use of the product, and requested information about the formula for Limbrel™, so that the formula itself could be reviewed.
By November 21, 2017, the FDA had received 194 adverse event reports regarding Limbrel™ covering the past decade. Based on those adverse event reports, the FDA determined that there was a close relationship between use of Limbrel™ and a number of adverse events including two life-threatening conditions — drug-induced liver injury and hypersensitivity pneumonitis. According to the FDA, these conditions may present in rare cases with varying degrees of severity in patients taking Limbrel™ for the first time in the initial weeks of exposure, and may go unnoticed by the patient until the patient consults with their physician or until symptoms develop that require hospitalization. The FDA issued an FDA Advisory, notifying consumers and health care professionals of the association between them Limbrel™ and these life-threatening conditions. The FDA recommended that consumers immediately stop taking Limbrel™ and that health professionals advise their patients to stop taking Limbrel immediately.
Symptoms associated with liver injury include jaundice, nausea, fatigue, and discomfort, and it is often associated with elevated liver function tests. Symptoms of hypersensitivity pneumonitis include fever, chills, malaise, cough, chest tightness, dyspnea, rash, swelling, shortness of breath, chronic bronchitis, and headache.
On November 22, 2017, Primus Pharmaceuticals updated its website, advising Limbrel™ prescribers to limit Limbrel™ use to established patients only.
On November 30, 2017, the FDA recommended that Primus Pharmaceuticals issue a voluntary recall of Limbrel™ due to “the agency’s safety concerns and serious health risks associated with continued use of the product.” The FDA also expressed concern that Limbrel™ was actually an unapproved new drug for which FDA approval was necessary and that it did not fit into the category of “medical food” product.
On December 18, 2017, the FDA sent a letter to the president and Chief Executive Officer of Primus Pharmaceuticals, requesting that the company “cease distribution and immediately issue a recall” of all Limbrel™ products based on its determination that Limbrel™ products are unapproved new drugs, rather than “medical food” and therefore require prior approval from the FDA before they can be placed in the market. Moreover, the FDA said that Limbrel™ is misbranded under section 502(c) of the Federal Drug and Cosmetic Act because it is false and misleading for Primus Pharmaceuticals to call Limbrel™ a “medical food” there are no specific nutritional requirements for people with osteoporosis.
On January 28, 2017, Primus Pharmaceuticals announced a voluntary nationwide recall of Limbrel™ due to “rare but serious and reversible adverse events while seeking FDA’s cooperation to restore access for patients with medical necessity.” The manufacturer continues to dispute the causal connection between Limbrel™ and any of the life-threatening conditions that the FDA believes to be associated with the product.
Williams Cedar’s Dangerous Drug Lawyers Fight for Compensation for Those Injured by Harmful Pharmaceutical Products
If you or a loved one suffered an adverse event that you believe is attributed to taking Limbrel™, we can help. Call our dangerous drug lawyers today at Williams Cedar at 215-557-0099 or contact us online.