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Tennessee Limbrel Lawyer

Osteoarthritis is a degenerative joint disease that occurs when the cartilage or cushion between a person’s joints starts to break down. This frequently leads to pain, stiffness, and swelling in the affected areas. Doctors often prescribe medication to assist patients in dealing with the symptoms of osteoarthritis.

In some cases, doctors also prescribe “medical foods.” These are products specially formulated to assist in the dietary management of individuals with a specific medical condition. Like drugs, medical foods must be taken under the supervision of a licensed physician. But unlike drugs, medical foods are not subject to premarket review by the U.S. Food and Drug Administration (FDA).

But the FDA can recall a medical food if there is evidence it poses a danger to public health. For example, in January 2018 the FDA announced the recall of flavocoxid, a medical food product derived from plants and marketed by Primus Pharmaceuticals under the trade name of Limbrel. The FDA expressly ordered the “recall of all non-expired lots of Limbrel” after receiving multiple reports of “rare but serious and reversible side effects,” notably liver injury, associated with the product.

If you have taken Limbrel and sustained liver injury as a result, you may be entitled to seek compensation from Primus Pharmaceuticals and other responsible parties. The qualified Tennessee Limbrel lawyers at Fox & Farley can review your case and help you understand your legal options going forward.

FDA Cites Over 200 “Adverse” Incidents Involving Limbrel

The FDA began investigating Limbrel’s potential side effects in September 2017. By December, the agency said it received “200 adverse event reports regarding Limbrel”–some dating back more than 10 years–mostly involving liver injury and hypersensitivity pneumonitis, a type of lung inflammation. In at least 30 of the 200 adverse events reported, the FDA said Limbrel was the cause of these problems.

But even after the FDA raised serious questions about Limbrel’s safety to Primus Pharmaceuticals in November 2017, the company refused to take the product off the market. It was not until the FDA “formally requested” a recall of non-expired lots a few weeks later the company took any action at all. But even as recently as January 2018, Primus continued to defend the safety of Limbrel, even as it complied with the FDA’s recall demand.

Act Today to Preserve Your Legal Rights

The FDA says that “[a]nyone who is currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis.” You should stop taking the product immediately and contact your doctor for more information.

And if you are a Limbrel user who has experienced liver or lung injuries, you need to take action now to preserve your legal rights. Manufacturers like Primus may be held liable not only for marketing dangerous or defective drugs, but also for improper labeling that fails to properly warn consumers about the health risks associated with their products. So if you have questions or concerns about your right to seek damages from the manufacturers of Limbrel, contact Fox & Farley today at 866-862-4855.

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