Our law firm is offering a free confidential Limbrel lawsuit evaluation. We are investigating a product liability lawsuit for injuries from Limbrel, a product made by Primus Pharmaceuticals, an Arizona firm. The U.S. Food and Drug Administration (FDA) has recommended that Primus Pharmaceuticals voluntarily recall Limbrel, and our law firm is joining the FDA in urging the company to issue an immediate recall. This type of action is needed by the company because the FDA does not have mandatory recall authority over drug products.
Limbrel Lawsuit Possible Even without Recall
To date, Primus Pharmaceuticals has not recalled this product. Consumers injured by this product should know that a Limbrel lawsuit is still possible, and it may be the only way for consumers to get answers, compensation and justice.
According to the FDA, there is an association between this product and severe, life-threatening illness.
The use of Limbrel is associated with the risk of drug-induced liver failure and a lung condition called hypersensitive pneumonitis.U. S. Food and Drug Administration
With no authority to force a recall, the FDA has reached out to consumers, urging them not to use Limbrel because of these liver and lung injury risks. The FDA recommends that these consumers contact their health care providers. This is an important step to protect your health and to find out if you have been harmed by this product.
Limbrel is a capsule marketed to “manage the metabolic processes associated with osteoarthritis” (FDA). The product is marketed as a medical food, but the FDA preliminary determination is that it is an unapproved new drug. Even though the finding is that it is unapproved, the agency still does not have the authority to recall the product.
Limbrel Investigation Finds Risk of Liver and Lung Injury
In early September of this year, 2017, the FDA began investigating a rise in reports of serious harm from taking Limbrel, including drug-induced liver injury and a lung condition called hypersensitivity pneumonitis, an inflammation of the aveoli that is also called allergic alveolitis and extrinsic alergic alveolitis. As of November 21, 2017, the FDA had received 194 of these reports. For 30 of those cases, “there was sufficient information for FDA medical experts to determine whether Limbrel was likely associated with these adverse events” (FDA). The CIOMS causality assessment method was used to connect the illnesses to Limbrel.*
On November 8, 2017, the FDA first contacted Primus Pharmaceuticals regarding the adverse events and requested information about the formula for Limbrel. Since that time the FDA has been reviewing the formula. It also obtained product samples from the company and is testing those samples. Some of the testing has been completed, and some is ongoing. A full analysis of the test results will be done when all of the data is available.
Based on preliminary results, on November 30, 2017, the FDA recommended that Primus Pharmaceuticals issue a voluntary recall of Limbrel due to “the agency’s safety concerns and serious health risks associated with continued use of the product” (FDA). To date, the company has not taken the product off of the market.
If you are taking Limbrel, you should do the following:
- immediately stop taking it (FDA recommendation);
- contact your doctor;
- contact a lawyer, either one at our law firm or another lawyer, to make sure your legal rights are protected;
- work with your doctor and attorney to report any symptoms of liver or lung injury to the FDA.
Contact Attorney Fred Pritzker for Help
What Should I Do if I Have Symptoms of Illness from Limbrel?
Anyone who is currently taking Limbrel may be at risk for developing symptoms associated with drug-induced liver injury and/or hypersensitivity pneumonitis.
Symptoms of drug-induced liver injury can vary and may include jaundice (a yellowing of the skin), nausea (feeling like you want to throw up), fatigue (being extremely tired), and gastrointestinal (stomach and bowel) discomfort. Symptoms of hypersensitivity pneumonitis may include fever (an above-normal temperature), chills, headache, cough, chronic bronchitis (inflammation of the lungs’ bronchial tubes), shortness of breath or trouble breathing, weight loss, and fatigue. If you have any of these symptoms, contact your health care provider immediately. You can also contact our law firm using the form above to let us know what you are going through and to find out if we can help you protect your legal rights.
What Products is the FDA Urging Primus Pharmaceuticals to Recall?
The FDA is urging Primus Pharmaceuticals to recall Limbrel, a capsule marketed in two dosages: Limbrel250 and Limbrel500. “The labeling states that the products contain two types of flavonoids: baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu). Both dosages also contain zinc. Claims made on the product label and in labeling indicate that Limbrel is intended to manage the metabolic processes associated with osteoarthritis.” (FDA)
*The Council for International Organizations of Medical Sciences (CIOMS) causality assessment method was used to determine the likelihood that an association between the consumption of Limbrel and 30 of the adverse events reported to the FDA. CIOMS is a non-government, nonprofit organization that was founded by the World Health Organization (WHO) and the United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949. It has been a leader in public health research since its inception.