The FDA has asked Primus Pharmaceuticals, who produces Limbrel, to voluntarily recall the flavocoxid capsules due to adverse effects being reported. Last month, an FDA report advised those taking Limbrel to cease doing so immediately and contact their health provider.
Limbrel is a capsule marketed to “manage the metabolic processes associated with osteoarthritis.”. It is marketed as a medical food, not a drug, and therefore is not required to undergo premarket review or approval by FDA. The FDA has said in its report that “although the product is marketed as a medical food, the preliminary determination of the FDA investigation is that Limbrel is an unapproved new drug.”
Those taking Limbrel may experience acute drug-induced liver injury with symptoms that include jaundice, fatigue, nausea and other gastrointestinal discomforts. They may also experience hypersensitivity pneumonitis with symptoms like fever, chills, headache, cough, chronic bronchitis, shortness of breath or trouble breathing. If you have experienced these symptoms, the FDA urges you to contact a medical professional and ask them to report your symptoms to the FDA through the MedWatch Safety Information and Adverse Event Reporting Program.
You can read the FDA statement in full here.
If you or someone you know has taken Limbrel and experienced an adverse event, you may be entitled to compensation. Our dangerous drug lawyers at Williams Cedar are ready to take on manufacturers of dangerous drugs and hold them accountable. Call us at 215-557-0099, or contact us online to schedule a consultation today. We are dedicated to helping you claim the justice and compensation you deserve. Our offices are located in Philadelphia and Cherry Hill, New Jersey and we serve clients nationwide.