Osteoarthritis Product Limbrel Has Been Linked to Potentially-Threatening Injuries and Illnesses

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The Food and Drug Administration (FDA) has been investigating the osteoarthritis product Limbrel after a series of adverse effects was potentially linked to the product. In December of 2017, the FDA issued a recall request to Primus Pharmaceuticals for the following capsules:

  • Limbrel (flavocoxid) 250 mg capsules
  • Limbrel250 (250 mg flavocoxid with 50 mg citrated zinc bisglycinate) capsules
  • Limbrel (flavocoxid) 500 mg capsules
  • Limbrel500 (500 mg flavocoxid with 50 mg citrated zinc bisglycinate)

According to the FDA warning, “consumers [should not] 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. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.”

If you or a loved one has been injured as a result of taking Limbrel, contact the defective drug attorneys of Bailey & Greer, PLLC to learn more about your rights and options.

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What is Limbrel?

Limbrel is classified as a medical food: “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” In short, it is not quite a drug, but because Limbrel is prescribed, it is also not a dietary supplement.

In particular, Limbrel is used to manage osteoarthritis. Certain metabolic processes can trigger inflammation in the joints of patients with OA, and Limbrel was designed to help ease that inflammation.

What is hypersensitivity pneumonitis?

One of the potential adverse effects of taking Limbrel is a condition called hypersensitivity pneumonitis. The disease causes the lungs to become inflamed in reaction to chemicals, molds, dusts, or fungus. If it is caught early enough, the condition is entirely reversible. If the disease progresses, however, it cannot be cured. The only treatments available are steroids, which will help manage the symptoms without curing you of the disease. Under certain circumstances, patients can develop tissue scarring on the lungs or go into acute respiratory distress, which could prove fatal.

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What is drug-induced liver injury?

Drug-induced liver injury is a rare but life-threatening condition. Your liver not only aids in digestion, it also filters out harmful chemicals in your blood and produces proteins your body needs to survive. Drug-induced liver injuries occur when your body has an allergic reaction to a medication, when your body has been subjected to repeated doses of a medication or, in some cases, when your genetic makeup is incompatible with the medication. If undetected or left intreated, it can eventually be fatal.

The most common signs of drug-induced liver injury include:

  • Jaundice
  • Nausea
  • Fatigue
  • Gastrointestinal discomfort

Why didn’t the FDA pull Limbrel from the market?

Because of the way the FDA’s regulatory powers are defined, it could force Primus Pharmaceuticals to pull Limbrel from the shelves. It can, and has, issued safety warnings and investigated potential links between the product and adverse effects.

Facing mounting pressure from the FDA, Primus pulled Limbrel from the market in late December of 2017.

I’ve taken Limbrel for years. What now?

If you were prescribed Limbrel as part of your management plan for osteoarthritis, you should seek medical attention right away. Liver injury can take years to develop, and hypersensitivity pneumonitis could be confused with allergies or the flu. You should ask your doctor to run the necessary tests to assure you are healthy or to determine whether you should be started on a course of treatments.

If you have developed drug-induced liver injury or hypersensitivity pneumonitis as a result of taking Limbrel, you have legal options available to you. You should speak with a defective drug lawyer about your next steps.

Limbrel can cause life-threatening complications. If you were hurt, we can help

Bailey & Greer, PLLC is a premier personal injury law firm serving clients in Memphis, Jackson, and throughout West Tennessee. Our experienced defective drug lawyers can help you pursue compensation for your lost wages, medical bills, and pain and suffering. To learn more or to schedule your free consultation, please call 901-680-9777 or complete our contact form.

Bailey & Greer Team