Federal drug regulators are warning about the risk of severe and potentially life-threatening liver injuries that may be associated with side effects of Limbrel, an osteoarthritis medication that may soon be recalled from the market.
The FDA issued a safety alert on December 4, indicating that it has recommended that a Limbrel recall be issued. However, Primus Pharmaceuticals has not yet been willing to voluntarily pull the drug medication from the market.
Limbrel is marketed as a “medical food”, but the FDA is now reclassifying it as an unapproved new drug.
The agency first warned of potential Limbrel liver and hypersensitivity side effects in a safety alert last month. The investigation followed reports of serious side effects occurring among individuals who used the drug, which comes in capsule form for the treatment of osteoarthritis.
“The FDA reminds consumers not to use Limbrel because of the risk of drug-induced liver injury, and a lung condition called hypersensitivity pneumonitis. Consumers taking this product should stop immediately and contact their health care provider,” the agency warns. “Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.”
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.
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 FDA continues to investigate the drug, and 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 they experience any side effects.