Limbrel Lawsuits

Patients taking Limbrel capsules for osteoarthritis should be aware that on December 5, 2017, the FDA recommended for the product to be recalled. According to an FDA advisory, the product, which is manufactured by Primus Pharmaceuticals, has been linked to a risk of liver injury and other serious adverse events. The FDA recommends consumers “immediately stop taking it” and contact their healthcare providers.

Meanwhile, the FDA is examining the product’s formula. Though the manufacturer markets it as a medical food, a preliminary FDA investigation has determined that Limbrel “is an unapproved new drug” and that the products “represent a serious health hazard.”

On December 21, 2017, in response to actions taken by the FDA, Primus Pharmaceuticals suspended its promotion and sale of Limbrel.

What is Limbrel?

Limbrel (flavocoxid) is a “medical food product” made of substances from plant sources called “flavonoids.” More specifically, the product includes baicalin and catechins found in Scutellaria baicalensis (Baikal skullcap) and Acacia catechu (catechu or black cutch), respectively.

Some of the products also contain zinc glycinate. They come in capsule form with two dosing options (250 and 500 mg) to be taken daily. The manufacturer says the product works by reducing inflammation, which reduces swelling and pain.

The product was approved for use in chronic osteoarthritis in 2004, and though it is made of plant-derived ingredients, it is only available by prescription. The term “medical food” means that the product is formulated to be consumed under the supervision of a physician. According to the Orphan Drug Act, medical food products are intended 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 products differ from dietary supplements in that they’re not designed for healthy people, but as a treatment for a particular medical condition. They do not require formal premarketing safety and efficacy studies as drugs do.

Concerns over the product have caused the FDA to look more closely at the formula to see if the product should, indeed, be marketed as a drug rather than a medical food product.

Limbrel Linked with Liver and Lung Disease

The Limbrel label touts that it has few side effects, and in double-blind controlled trials, it had adverse events similar to that of a placebo. On December 18, 2017, however, the FDA sent a letter to Primus Pharmaceuticals requesting that they cease distribution and immediately initiate a recall of all Limbrel products because of health hazards.

The FDA reported that between January 1, 2007, and November 9, 2017, it received 194 adverse event reports associated with the products, which suggest that Limbrel is linked with drug-induced liver injury (DILI), pancreatitis, and hypersensitivity pneumonitis (HP). As of December 4, 2017, the FDA had received a total of 200 such reports.

These conditions can range from mild to life-threatening and can be particularly dangerous because they can exist without causing noticeable symptoms for some time. When the patient finally realizes something is wrong, the condition may have advanced to the point that hospitalization is required.

A drug-induced liver injury is a liver injury 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 lead to inflammation, impaired function, and even acute liver failure. Symptoms of liver problems may include jaundice, nausea, fatigue, and gastrointestinal discomfort.

Hypersensitivity pneumonitis (HP) is an inflammation of the tiny air sacs in the lungs. If the inflammation worsens, it can cause coughing, shortness of breath, chest tightness, fever, chills, and tiredness. People who already have lung conditions may experience an exacerbation of those diseases with HP.

Study Examines Four Cases of Limbrel-Related Liver Injury

In a 2012 study, researchers described four cases of patients who developed liver injury shortly after they began using Limbrel. All four were women with a mean age of 61 years. The time to the onset of the condition averaged about 11.2 weeks after they started taking the product. When the women stopped taking it, their livers recovered. The researchers concluded: “Flavocoxid can cause significant liver injury which appears to resolve within weeks after its cessation.”

The women were all treated with 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. None of the women were hospitalized, but two did require liver biopsies.

The researchers noted that 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 of those were taking Limbrel, and 12 were taking naproxen.

FDA Investigating to See if Limbrel Should be Marketed as a Drug

In the letter to Primus Pharmaceuticals, the FDA—in addition to urging a recall—noted that Limbrel was “misbranded” because it does not meet the definition of a medical food. It added that introducing a misbranded drug onto the market was a violation of the Federal Food, Drug, and Cosmetic Act.

As noted above, a medical food is meant to manage a disease or condition with distinctive nutritional requirements. The FDA, however, explained that it is “not aware of any distinctive nutritional requirements for individuals with osteoarthritis.” It also noted that there is no nutritional requirement for anyone for the flavonoid ingredients in Limbrel.

The FDA advised Limbrel in the letter that it anticipated classifying a forthcoming Limbrel recall as a “Class 1” 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.

Types of Injuries Associated with Limbrel

Individuals taking Limbrel may be at risk for the following conditions:

Pancreatitis
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.