Primus Pharmaceuticals Inc., under pressure by the Food and Drug Administration (FDA), is recalling all unexpired lots of Limbrel, a capsule used to “manage the metabolic processes associated with osteoarthritis,” because the drug has been linked to serious side effects.
Earlier this month, the FDA issued a letter to James D. Weir, president and chief executive officer of Primus, requesting the company cease distribution of Limbrel capsules and immediately recall specific lots of the drug because the agency determined that Limbrel products “represent a serious health hazard.”
The agency said it had received 194 adverse event reports associated with use of Limbrel products, including drug-induced liver injury, pancreatitis and a serious lung condition called hypersensitivity pneumonitis. After receiving the letter, the company announced it would issue a recall.
The FDA also took issue with the company’s claims that the medication was intended for the clinical dietary management of the metabolic processes of osteoarthritis. Such claims, the agency said, establish the product is an unapproved drug because it claims to cure, mitigate, treat or prevent disease.
In its recall notice, Primus Pharmaceuticals said that the FDA had only received 30 adverse event reports of “elevated liver function tests or hypersensitivity pneumonitis associated with the use of Limbrel products” from Jan. 1, 2007 to Nov. 9, 2017. “These conditions 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 they consult with their physician or until symptoms develop that require hospitalization,” the company said in a news release. “There have been no deaths reported with the use of Limbrel, and in all reported cases, adverse events resolved without residual effects after discontinuing use of the product.”
Primus Pharmaceuticals retained independent medical and former senior FDA safety experts to conduct a further investigation of the cases and the ingredients in Limbrel. “It is the opinion of these experts based on a thorough review of the medical literature, the adverse event reports to the FDA, and the FDA’s health hazard evaluation that there is no basis on which to conclude that Limbrel potentially causes life-threatening adverse events, and that none of the reported adverse events show liver failure or respiratory failure,” the company stated.
Despite these findings, and in cooperation with the FDA, Primus Pharmaceuticals voluntarily ceased its promotion of Limbrel on Dec. 21, 2017, and is now recalling all unexpired lots of Limbrel products. Affected products include Limbrel (flavocoxid) 250 mg capsules; Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules; Limbrel (flavocoxid) 500 mg capsules; and Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules.
The company said that it will work with the FDA to return Limbrel to the market as quickly as possible.
Patients who wish to return unopened bottles or who have questions regarding this recall should go to Limbrel.com. Any adverse events experienced while using these products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.