The Centers for Disease Control and Prevention (CDC) states that in Pennsylvania alone, nearly 2.9M people have arthritis. Though there are different types of the disease, osteoarthritis is the most common in the U.S., affecting about 10 percent of men and 13 percent of women 60 years and older. The disease causes joint inflammation, which breaks down the cartilage in the joints over time and leads to the development of pain, stiffness, and difficulty moving.
There is no cure for osteoarthritis, it is a degenerative disease that worsens over time. Individuals suffering from this condition often spend a lot of time seeking treatments that will provide relief. Non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin and ibuprofen can help with the symptoms, but can also cause dangerous side effects. Injections offer only temporary relief, and physical therapy and medication can help, but there is simply no magic cure to treat the pain and resulting dysfunction.
Enter Limbrel (flavocoxid), a so-called “medical food” product similar to a dietary supplement manufactured by Primus Pharmaceuticals. It is marketed as a non-drug solution from plant-sourced ingredients that promises to provide arthritis patients with “natural” relief. Limbrel is made up of baicalin and catechins (plant ingredients) found in Scutellaria baicalensis (Baikal skullcap) and Acacia catechu (catechu or black cutch).
It sounds like a promising option, and for years, many people used the product hoping to feel better. But on December 4, 2017, the Food and Drug Administration (FDA) released a health advisory alerting the public that it had recommended that Primus Pharmaceuticals voluntarily recall Limbrel because of health hazards.
The Pittsburgh lawyers at Chaffin Luhana are currently investigating cases in which Limbrel caused dangerous side effects. Meanwhile, if you or a loved one is taking Limbrel, the FDA recommends that you stop immediately and check with your doctor.
What is Limbrel?
Limbrel was approved in 2004 to treat chronic osteoarthritis. It’s sold by prescription in two doses: 250 mg and 500 mg. Though similar to a dietary supplement, the product is categorized as a medical food, which is regulated differently than dietary supplements.
According to the Orphan Drug Act, a medical food is defined as a food that is formulated to be taken under the supervision of a physician, and is intended for “the dietary management of a disease or condition for which distinctive nutritional requirements, based upon recognized scientific principles, are established by medical evaluation.”
Medical foods differ from dietary supplements as they are not meant to be taken by healthy people, but are formulated to treat a specific illness or condition. A physician prescribes them when a patient has particular nutrient needs. They are not classified as drugs, either, which means they are not subject to the more extensive clinical trial requirements that drugs are, or to the premarket approval process that new drugs have to pass.
Limbrel was the first medical food for the management of osteoarthritis that was approved for the U.S. market. When it came out, there was hope that it would be safer than NSAIDs because it had fewer bleeding and other side effects. But now, there are serious concerns that the product could cause life-threatening side effects.
Limbrel Linked with Liver and Lung Disease
On December 18, 2017, the FDA sent a letter to Primus Pharmaceuticals formally requesting they immediately recall all Limbrel products because of the risk of liver injury and other serious adverse events. In the letter, the FDA stated that Limbrel “products are unapproved new drugs and represent a serious health hazard.” Moreover, between 2007 and 2017, it received 194 adverse event reports associated with the products. These reports showed a close relationship between Limbrel and three health issues:
- Drug-induced liver injury (DIHI)
- Hypersensitivity pneumonitis (HP)
These problems presented in patients with varying severity, from mild to life-threatening. And symptoms associated with these conditions may not be recognized by the patient until they are severe enough to require hospitalization.
Hypersensitivity pneumonitis (HP) is an inflammation of the tiny air sacs in the lungs. If the inflammation continues to get worse, it can cause symptoms like coughing, shortness of breath, chest tightness, fever, chills, and tiredness. People who already have lung conditions may experience an exacerbation of those diseases if they also develop HP.
Pancreatitis is an inflammation of the pancreas that results in symptoms like severe upper abdominal pain, nausea and vomiting, fever, and an accelerated heart rate.
Drug-induced liver injury (DIHI) is a liver injury—like hepatitis or fatty liver—that can be caused by medications. The liver, which helps break down certain medications, may be damaged by the use of some drugs that can leading to inflammation, impaired function, and even acute liver failure. Symptoms of liver problems may include jaundice, nausea, fatigue, and gastrointestinal discomfort.
The FDA urged Primus to recall the products “to protect the public health and welfare.”
Study Examines Four Cases of Limbrel-Related Liver Injury
In a 2012 study, researchers sought to describe the characteristics of four patients who developed drug-induced liver injury caused by Limbrel (flavocoxid). All four were women with a mean age of 61, and they all suffered from liver damage within 5-16 weeks of starting Limbrel. Blood tests revealed elevated levels of alanine aminotransferase (ALT), which is a sign of liver damage. Blood tests also showed elevated levels of alkaline phosphatase and serum bilirubin—other signs of liver problems.
Fortunately, the doctors took all of the patients off Limbrel, and they recovered within 3 to 12 weeks of discontinuing the product. The researchers concluded: “Flavocoxid can cause significant liver injury which appears to resolve within weeks after its cessation.”
The researchers also noted that according to the product labeling, flavocoxid has few side effects, and that in double-blind controlled trials, its adverse event profile was similar to a placebo. Thus, neither patients nor their doctors had any warning about the potential for liver injury or other possible health effects.
FDA Investigating to See if Limbrel Should be Marketed as a Drug
In addition to recommending that Primus recall Limbrel, the FDA also stated that Limbrel did not fit the qualifications for a “medical food,” and instead, was actually an unapproved new drug distributed in violation of the Federal Food, Drug, and Cosmetic Act. The product is meant to treat a disease, yet they noted it is not generally recognized as safe and effective for its intended use, and therefore, is a new drug under section 201(p) of the Federal Food, Drug, and Cosmetic Act.
The FDA also informed the manufacturer that the products are misbranded because they say they’re “medical food” products for the clinical dietary management of the metabolic processes of osteoarthritis, yet the “FDA is not aware of any distinctive nutritional requirements for individuals with osteoarthritis,” particularly not a requirement for the ingredients in Limbrel—baicalin and catechin.
The FDA anticipates that the recall will be classified as a Class I recall, which is reserved for those situations where there is a reasonable probability that the product will cause serious adverse health consequences or death.
The FDA is continuing to investigate the product and the company, and will share updates as they become available. Meanwhile, Primus Pharmaceuticals states on their website that on December 21, 2017, “in response to unwarranted pressure from the FDA,” it voluntarily suspended the promotion and sale of Limbrel. It describes the FDA’s conclusions as “aggressive and far-reaching,” and notes that “recognized scientific and medical experts have written opinion letters to the FDA supporting the urgency of continued access to Limbrel….”
Types of Injuries Associated with Limbrel
Individuals taking Limbrel may be at risk for the following conditions:
- Drug-induced liver injury
- Hypersensitivity pneumonitis
- Immunological complications
The FDA has advised everyone who’s using Limbrel to stop and to check with their doctors to be sure they have suffered no adverse health reactions. Those who have experienced any of these injuries listed above are advised to report their symptoms to the FDA through the MedWatch Safety Information and Adverse Event Reporting Program.
The attorneys at Chaffin Luhana are actively investigating potential Limbrel lawsuits. Patients in the Pittsburgh and Ohio Valley areas who have taken this product and then experienced serious side effects may be able to recover damages in a Limbrel lawsuit. Call today for a free case evaluation at 1-888-316-2311.