Federal health regulators have launched an investigation into a potential risk of serious and potentially life threatening side effects with Limbrel, indicating that reports have been received involving liver injury and hypersensitivity pneumonitis.
The FDA issued a Limbrel safety alert on November 21, raising concerns about the product marketed as a “medical food”, which comes in capsule form for treatment of osteoarthritis. Yet, the agency indicates that there may be a risk of the serious lung condition or liver injury from Limbrel.
The agency is investigating reports involving serious side effects occurring among individuals who Limbrel, which is manufactured by Primus Pharmaceuticals.
The FDA received nearly 200 adverse event reports involving Limbrel problems. Two types of side effects were commonly reported, including issues with drug-induced liver injury and hypersensitivity pneumonitis.
Both are serious and potentially life-threatening medical conditions. Drug-induced liver injury may cause users to experience symptoms of jaundice, nausea, fatigue, and gastrointestinal discomfort. Hypersensitivity pneumonitis, which is a serious lung condition, may cause users to experience symptoms like fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, and fatigue. Prolonged experience of the symptoms may lead to life-threatening situations.
The FDA indicated, in addition to the warning, the formula for Limbrel is being reviewed by the agency. In the meantime, the agency is alerting consumers and health care providers about the serious side effects and is calling for consumers to stop using Limbrel immediately.
Doctors who know of patients taking Limbrel should advise their patients to stop taking the product immediately.
Limbrel is manufactured in capsule form and marketed as a medical food to “manage the metabolic processes associated with osteoarthritis.” It comes in two dosages: Limbrel 250 and Limbrel 500.
Both dosage capsules contain two types of flavonoids, baicalin and catechin. Both also contain amounts of zinc. The Limbrel label indicates the drug is formulated to help treat and manage osteoarthritis.
The FDA said it has continued the ongoing investigation of Primus Pharmaceuticals and the side effects of Limbrel. In the interim, the agency strongly urges consumers to stop taking the product and to contact the FDA MedWatch Adverse Event Reporting program, either online or by calling 800-332-1088, if any side effects are experienced.