Limbrel Public Health Alert Issued by the FDA | LowestMed

The FDA has issued a public health alert for the osteoarthritis capsule Limbrel, due to a rise in reports of serious adverse events. Adverse events being reported include drug-induced liver injury and a lung condition called hypersensitivity pneumonitis.

What to do if you are taking Limbrel

It is recommended, by the FDA, that consumers stop taking Limbrel immediately and contact their health care provider. FDA officials also recommend that health care providers, who have patients taking Limbrel, advise patients to stop using it.

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Limbrel is a prescription dietary supplement, in capsule form, marketed to “manage the metabolic processes associated with osteoarthritis.” The capsule works by reducing inflammation in affected joints.

During the FDA’s investigation, they have found that Limbrel is not approved by the organization. They are currently reviewing the formula and are testing Limbrel samples.

Who makes Limbrel?

Limbrel is manufactured by Primus Pharmaceuticals, out of Scottsdale, Arizona. The manufacturer has not yet removed the product from the market.

Limbrel recall investigation history

The FDA began investigating a rise in reports of serious adverse events, related to Limbrel, in early September 2017. The events included drug-induced liver injury and a lung condition called hypersensitivity pneumonitis.

A total of 194 adverse event reports, related to Limbrel, have been received by the FDA since November 21, 2017. In 30 of those cases, FDA medical experts determined that Limbrel was likely associated with the adverse events.

Symptoms of drug-induced liver injury

Symptoms of drug-induced liver injury can vary and may include jaundice, nausea, fatigue, and gastrointestinal discomfort. If you experience any of these symptoms, contact your health care provider immediately.

Symptoms of hypersensitivity pneumonitis

Symptoms of hypersensitivity pneumonitis can vary and may include fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing, weight loss, and fatigue. If you experience any of these symptoms, contact your health care provider immediately.

What is Limbrel? 

Limbrel, or bioflavonoids, are used in alternative medicines, as an aid to enhance the action of vitamin C, as an antioxidant, to support blood circulation, and to treat allergies, viruses, or arthritis and other inflammatory conditions.

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