Side effects of the injectable osteoarthritis medication Limbrel (flavocoxid) may include drug-induced liver injury and a severe lung condition called hypersensitivity pneumonitis.
Free Confidential Lawsuit Evaluation: If you or a loved one has been injured by the side effects of Limbrel, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What is Limbrel?
Limbrel (generic: flavocoxid) is a medical food product used to treat osteoarthritis (OA). Primus Pharmaceuticals, the company that makes Limbrel, says the drug works by “restoring our body’s metabolic balance, especially those responsible for inflammation.” Limbrel was approved by the U.S. Food & Drug Administration (FDA) in 2009.
What’s the Problem?
FDA on December 5, 2017, issued a Drug Safety Alert indicating that it had advised Primus Pharmaceuticals to recall Limbrel after an investigation determined it to be an “unapproved new drug.” The agency also warned consumers to avoid Limbrel, as it has been linked to nearly 200 reports of serious side effects including drug-induced liver injury and hypersensitivity pneumonitis. To date, Primus has not recalled Limbrel, according to the FDA.
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Limbrel Side Effects
Serious side effects of Limbrel may include:
- Drug-induced liver injury
- Hypersensitivity pneumonitis
- Immunological complications
Other, less severe side effects:
- Nausea
- Diarrhea
- Gas
- Rash
- Itching or swelling (especially of the face/tongue/throat)
- Severe dizziness
- Trouble breathing
Drug-Induced Liver Disease
Drug-induced liver diseases are liver injuries caused by prescription medications, over-the-counter (OTC) drugs, vitamins, hormones, herbs, toxins and illegal drugs. Signs and symptoms include:
- Jaundice
- Nausea
- Fatigue
Drugs like Limbrel may cause liver disease by either damaging the organ directly, or by being transformed into toxic chemicals inside the liver. There are three types of liver toxicity - dose-dependent toxicity, idiosyncratic toxicity, and drug allergy.
Hypersensitivity Pneumonitis
Hypersensitivity pneumonitis (HP) is a group of pulmonary disorders characterized by inflammation of the alveoli within the lung caused by hypersensitivity to inhaled organic dusts. Signs and symptoms include:
- Fever
- Cough
- Heavy breathing
Hypersensitivity pneumonitis may also be referred to as allergic alveolitis or extrinsic allergic alveolitis (EAA).
What is a Medical Food Product?
FDA classifies medical foods as products specifically formulated for dietary management of diseases or conditions with distinctive nutritional needs which cannot be met by diet alone. According to MedScape [1], a product must meet the following criteria to be labeled a "medical food”:
- A specific formulation (as opposed to a naturally occurring foodstuff in its natural state) for oral or tube feeding;
- Labeled for the dietary management of a specific medical disorder, disease, or condition with distinctive nutritional requirements;
- Intended for use under medical supervision, and
- Intended only for a patient receiving active and ongoing medical supervision for a condition requiring medical care on a recurring basis.
Do I Have an Limbrel Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Limbrel lawsuits. We are handling individual litigation nationwide and currently accepting new drug-induced liver injury and hypersensitivity pneumonitis cases in all 50 states.
Free Drug Lawsuit Evaluation: Again, if you were harmed by Limbrel side effects, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and we can help.
