What Pharmacists Need to Know About Limbrel

The FDA is recommending that patients immediately stop using medical food product Limbrel and contact their health care providers, as anyone taking the capsules is at risk for serious adverse effects.¹ Pharmacists can play a key role in identifying osteoarthritis patients taking Limbrel to convey this important information. It is also important for health care professionals to report any adverse effects associated with Limbrel to the FDA’s Medwatch Safety Information and Adverse Event Reporting Program.¹

The FDA said that it is investigating Limbrel for the risk of life-threatening adverse effects, after receiving 194 adverse-event reports regarding the prescription capsules.¹ Of these reports, 57 of the cases contained sufficient information to evaluate whether Limbrel was associated with an adverse event.¹ Additionally, 30 of the 57 cases contained adequate information to use a causality assessment method to determine the likelihood of an association between Limbrel and the adverse effects.¹ The FDA contacted Primus Pharmaceuticals, the manufacturer of Limbrel, regarding the adverse events and requested the formula information for further review and said that it will provide future updates.

Drug-induced liver injury and hypersensitivity pneumonitis are the 2 most severe adverse effects reported with Limbrel use.¹ Symptoms of drug-induced liver injury include jaundice, nausea, fatigue, and gastrointestinal discomfort. Hypersensitivity pneumonitis is caused by repeated exposure to environmental substances that cause inflammation in the lungs when inhaled.² The substances include bacteria, fungi or molds, proteins, and chemicals. Signs and symptoms of hypersensitivity pneumonitis include flu-like symptoms, cough, shortness of breath, weight loss, fatigue, lung fibrosis, and clubbing of the fingers or toes.²

Pharmacists can update physicians regarding this safety communication about the possible risks of drug-induced liver injury and hypersensitivity pneumonitis.

Limbrel is classified as a medical food product and is not regulated by the FDA as a drug. Medical-food labeling must contain a statement of identity; an accurate statement of the content quantity; manufacturer information; and a complete list of ingredients.³ The FDA does maintain a compliance program for medical foods to evaluate the manufacturing process, collect samples for testing, and recommend specific actions for violations.³

Limbrel is used for the dietary management of osteoarthritis.⁴ The dose range is 250 mg to 500 mg orally every 12 hours, and it is not recommended for patients under 18. The product contains 2 flavonoids (baicalin and catechin) and zinc. The product labeling reports that Limbrel can cause borderline elevations of liver enzyme tests. Additionally, there are rare (less than 0.003%) reports of hypersensitivity pneumonitis reported.

References

1. FDA. Limbrel capsules by Primus Pharmaceuticals: FDA advisory-linked to potentially life-threatening health problems. fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586111.htm. Published November 21, 2017. Accessed November 21, 2017.

2. National Heart, Lung, and Blood Institute. Hypersensitivity pneumonitis. nhlbi.nih.gov/health/health-topics/topics/hp. Updated May 27, 2016. Accessed November 21, 2017

3. FDA. Frequently asked questions about medical foods; second edition. fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM500094.pdf. Accessed Published May 2016. November 21, 2017.

4. Primus Pharmaceuticals. Limbrel. limbrel.com/. Accessed November 21, 2017.