Limbrel Liver Injury
On December 5, 2017, the FDA recalled the osteoarthritis medication, Limbrel. Manufactured by Primus Pharmaceuticals, Limbrel can cause liver injury and other serious adverse events. The agency advised immediate stoppage of the drug.
Approved by the FDA in 2004, Limbrel (flavocoxid) is a “medical food product” made of plant sources or flavonoids and sometimes zinc glycinate. Patients take a capsule in either 250 or 500 mg daily. According to the manufacturer, the medication works by reducing inflammation. Therefore, the reduced inflammation diminishes swelling and pain associated with osteoarthritis.
The term “medical food” means that a patient can only use the product under the supervision of a physician. According to the Orphan Drug Act, medical food products are for the “dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Medical food, unlike drugs, do not require formal premarket safety studies.
Limbrel Liver Injury
Studies have linked Limbrel to life-threatening medical conditions. The FDA reported that between January 1, 2007, and November 9, 2017, it received almost adverse event reports associated with the products. These include Limbrel liver injury and hypersensitivity pneumonitis. Hypersensitivity pneumonitis is when the lungs become swollen and irritated due to an allergic reaction from dust, fungus or chemicals. After receiving these reports, in November 2017 the FDA advised Limbrel manufacturer, Primus Pharmaceuticals to recall the product. Primus declined.
Then, in December 2017, the FDA made a formal recall request of both Limbrel250 and Limbrel500 with or without zinc due to Limbrel liver injury risk.
Liver Injury Study
A 2012 study showed a number of patients developed a liver injury within 12 weeks of beginning Limbrel. All were women with an average age of 61. Ceasing the product reversed the liver injury. All women used Limbrel in doses of 250 to 500 mg twice daily for arthritis or other types of musculoskeletal pain, including low back pain and fibromyalgia. All developed symptoms like jaundice, abdominal pain, fever, and rash. No one required hospitalization, however, two received liver biopsies.
Also, study researchers noted other published clinical trials on flavocoxid reported rare instances of liver toxicity. In one randomized controlled study comparing flavocoxid (500 mg twice daily) to naproxen (500 mg twice daily) for 12 weeks to treat osteoarthritis, 28 of the 220 patients showed evidence of liver problems at week 12. Sixteen took Limbrel while 12 received naproxen.
FDA Warnings About Limbrel
In early September 2017, the FDA began investigating an increase in reports about serious adverse events involving Limbrel. Then, by November the FDA received almost 200 adverse event reports. The reports had enough information to link the drug to liver damage, pancreatitis, and hypersensitivity pneumonitis.
Therefore, the FDA issued a public advisory on Nov. 21, 2017, warning that the use of Limbrel can cause patients to develop severe adverse events, which can be life-threatening, and that all patients should stop taking the drug immediately. Following the warning, the FDA requested the drug’s manufacturer, issue a voluntary recall of the product.
After the company failed to issue a recall, the FDA formally requested that the company stop distribution and issue an immediate recall of the following products:
- 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) capsules
The FDA has recommended a Class I recall of the drug, which represents a serious health hazard that may be life-threatening.
Limbrel Side Effects
Limbrel side effects range from mild to life-threatening. Also, this can be dangerous since many do not experience any noticeable symptoms for a while. Then, when he or she does notice, it could be too late and the patient needs hospitalization. The two most serious side effects of Limbrel include liver injury and hypersensitivity pneumonitis (HP). Hypersensitivity pneumonitis (HP) is an inflammation of the tiny air sacs in the lungs
Common Limbrel liver injury side effects include:
- Gastrointestinal discomfort
HP side effects also include:
- Shortness of breath
- Chest tightness
When manufacturers produce unsafe products that create pain and suffering, you deserve compensation. Although no amount of money will change the fact that you have suffered a serious injury because of manufacturer irresponsibility, compensation will help offset your current and future medical costs, as well as provide for the pain and suffering you have experienced. By filing, you may also help protect others from needless distress.
We Want to Help Victims
Furthermore, it is your right for manufacturers to inform you about the long-term risks associated with medications, and it is the responsibility of manufacturers to provide this information. If you developed cancer after taking a Valsartan medication, you should demand accountability from Sanofi Genzyme.
Of course, we want to help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and likewise, we have the experience necessary to successfully litigate these cases.
Contact the Michael Brady Lynch Firm today for a free consultation to learn more about seeking justice. Compensation may be available for any medical expenses associated with this ordeal, as well as for your physical and emotional suffering. There is no obligation.
How We Can Help
When you experience side effects from a dangerous drug, it can have devastating effects on your entire life. You also may be entitled to compensation for their injuries and damages. The types of losses we can help you recover include:
If a person dies from complications from a drug, family members may also be able to recover damages for the wrongful death of their loved one, including:
- Funeral expenses
- Medical expenses prior to death
- Loss of economic support; and
- Loss of companionship
Therefore, if a jury finds the conduct of a company to be highly reckless, they may award punitive damages to punish the company and deter similar conduct in the future. If you developed a liver injury after taking Limbrel, please speak to us to learn more about your rights.