In January 2018 Primus Pharmaceuticals announced a recall of Limbrel, an osteoarthritis medication after the FDA warned users to immediately stop the medication. Also, the FDA found Limbrel caused potentially life-threatening side effects like liver damage and a lung condition called hypersensitivity pneumonitis. Both can be fatal.
Manufactured by Primus Pharmaceuticals, Limbrel is a capsule that is currently being advertised as a “medical food” that can manage the metabolic processes associated with osteoarthritis. It comes in two dosages (Limbrel250 and Limbrel500). The label states that Limbrel contains two types of flavonoids baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu). Both types of Limbrel also contain zinc. The FDA is reviewing the formula since researchers link the drug to a wide range of severe side effects. The FDA has received almost 200 adverse reports so far.
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
The side effects in the Limbrel recall can be life-threatening. The two most serious are drug-induced liver injury and hypersensitivity pneumonitis. Liver damage can reduce normal liver function. The most common sign is elevated blood levels of AST and ALT, which are enzymes that leak from the injured liver and into the blood. Other symptoms include itching, loss of appetite, fatigue, and nausea.
Also, the other side effect is hypersensitivity pneumonitis. This is an immune system disease in the lungs. It occurs in some people when substances they ingest trigger their immune systems to over-react, causing inflammation in the lungs. This makes it harder for the lungs to function properly. Over time, chronic inflammation can cause irreversible lung scarring.
We Want to Help Limbrel Victims
Undeniably, it is your right to be informed about the long-term risks associated with the medications you take, and it is the responsibility of drug companies to provide this information. If you or a loved one took Limbrel and suffered drug-induced liver injury and hypersensitivity pneumonitis, you should demand accountability. We want to also help send a message that this is not acceptable. We are advocates for consumers who have been harmed by dangerous products, and 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. A verdict or settlement may give you compensation for their injuries and damages. The types of recoverable losses are:
- Past and future medical expenses
- Lost wages
- Loss of an ability to work; and
- Pain and suffering
Also, if a person dies from complications from a drug, family members may 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
If a jury finds the conduct of a drug company in manufacturing and selling a drug to be highly reckless, they may award punitive damages. These damages aim to punish the company and deter similar conduct in the future. Therefore, if you suffered drug-induced liver injury and hypersensitivity pneumonitis from Limbrel, please speak to us to learn more about your rights.