Limbrel Injury Lawsuits and Claims

Essure | Permanent Contraceptive & Hysterectomy Schmidt National Law Group 8
Essure | Permanent Contraceptive & Hysterectomy
December 14, 2017
Gadolinium Lawsuits and Claims Schmidt National Law Group 3
Gadolinium Lawsuits and Claims
January 4, 2018

Limbrel Injury Lawsuits and Claims

Millions of people around the world suffer from osteoarthritis, the most common form of arthritis.

People with osteoarthritis are finding that some medical products marketed to help with their condition may actually be causing serious, life-threatening health problems. Limbrel is a medical food product used by people with osteoarthritis to maintain a healthy metabolic process. The maker of Limbrel, Primus Pharmaceuticals, says its product helps provide the necessary nutrients for people with the condition that they couldn’t otherwise get from their diet alone.

Despite being on the market since 2004, Limbrel is the subject of a number of new adverse event reports and the U.S. Food and Drug Administration (FDA) is now warning anyone taking Limbrel should stop immediately and consult their doctors.

Limbrel has been associated with life-threatening medical conditions known as drug-induced liver injury and hypersensitivity pneumonitis. These conditions are serious and have been linked to Limbrel by the FDA’s own analyses.

If you took Limbrel for your osteoarthritis symptoms, you may be entitled to financial compensation.

Potential Limbrel Lawsuits

People who took Limbrel for osteoarthritis are learning the product may be doing more harm than good. The FDA is asking the manufacturer of Limbrel to take it off the market. Meanwhile, the regulatory agency is warning anyone who is taking the product to stop taking it immediately.

Limbrel is marketed to manage the metabolic processes associated with osteoarthritis. It is a type of prescription medical food regulated by the FDA, but it has been associated with an increasing number of adverse health effects. The FDA warns Limbrel may cause drug-induced liver injury and a lung condition called hypersensitivity pneumonitis.

Schmidt National Law Group is currently looking into potential lawsuits against the manufacturer of Limbrel, Primus Pharmaceuticals. People suffering from osteoarthritis who took Limbrel and developed one of these serious medical conditions are urged to speak with an attorney as they may be entitled to financial compensation. There may be significant rewards in the form of cash settlements and payouts.

Call Schmidt National Law Group today at 800-631-5656 to speak with one of our experienced lawyers and to see if you qualify for a potential Limbrel lawsuit.

Limbrel Compensation Evaluation

Please fill out to the best of your knowledge.

Step 1 of 6

16%

What is Limbrel?

Limbrel is a prescription product used to meet the nutritional requirements of patients with osteoarthritis. Limbrel was introduced in 2004 and is marketed as a medical food. Each Limbrel capsule contains flavocoxid — a proprietary blend of natural ingredients comprised mainly of the flavonoids baicalin and catechin. These ingredients can be found in natural foods such as soy, peanuts, cauliflower, kale, apples, and green tea.

Limbrel is sold in 250 mg and 500 mg doses. Some Limbrel capsules contain Zinc in addition to flavocoxid. The ingredients in Limbrel are provided in levels needed to meet the distinctive nutritional requirements of people with osteoarthritis, according to the drugmaker Primus.

Because Limbrel’s ingredients have been widely researched and are “generally recognized as safe” according to FDA standards, Limbrel was not approved by the FDA through its regular drug channels. This means comprehensive safety and effectiveness studies were not conducted before Limbrel was brought to market; though Limbrel is regulated by the FDA and must be obtained through a doctor’s prescription.

Many patients taking Limbrel have found, however, that the capsules may be causing severe health problems, including liver damage and a dangerous lung condition. A number of these patients have filed adverse event reports with the FDA and are considering filing lawsuits against the maker of Limbrel.

How Does Limbrel Work?

Limbrel works by managing the metabolic processes associated with osteoarthritis. The ingredients in Limbrel act on specific signaling pathways in the body to restore the proper metabolic balance of inflammatory metabolites at the cellular level, according to Primus.

Primus boasts Limbrel’s “unique mode of action” can work in as little as a few hours in people with mild to moderate osteoarthritis.

A rise in adverse event reports related to Limbrel, however, has patients, doctors, and the FDA concerned about the safety of Limbrel.

Safety Concerns

A number of adverse event reports have been submitted to the FDA that show Limbrel may cause serious health problems in some patients. These health problems include drug-induced liver injury and a lung condition called hypersensitivity pneumonitis.

Drugmaker Primus, on the other hand, claims that Limbrel is both safe and effective. The drugmaker wrote on its website:

“In clinical studies, Limbrel has been shown to have side effects comparable to placebo. To date, the number of side effects reported by physicians and patients about Limbrel has been less than 0.2% , exceptionally low compared to most other prescription products.”

The FDA says otherwise. The federal agency has warned patients currently taking Limbrel to stop taking the medical product immediately and consult their physician. As of November 21, 2017, the FDA said it received nearly 200 adverse event reports; many of these reports could be used to definitively determine that Limbrel was likely the cause of the patient’s health problems.

The regulatory agency said it continues to receive reports of health concerns in patients taking Limbrel for their osteoarthritis.

Drug-Induced Liver Injury

Limbrel has been associated with a certain type of liver damage called drug-induced liver injury. This means absent the use of Limbrel, the patient would not experience liver damage, and the damage usually subsides once the product is discontinued.

Symptoms of drug-induced liver injury vary, but may include:

  • Jaundice
  • Nausea
  • Fatigue
  • Gastrointestinal discomfort

Patients who experience drug-induced liver injury should immediately discontinue Limbrel and consult their physician. The FDA recommends any patient taking Limbrel, regardless of whether or not they experience problems, should stop taking Limbrel immediately and call their doctor.

Hypersensitivity Pneumonitis

Hypersensitivity pneumonitis is a disease of the lungs in which the lungs become inflamed, typically as a result of an allergic reaction to inhaled dust, fungus, molds, or chemicals, according to the American Lung Association. Hypersensitivity pneumonitis can cause lung scarring if it is not detected early.

Symptoms of hypersensitivity pneumonitis include:

  • Fever
  • Chills
  • Headache
  • Cough
  • Chronic bronchitis
  • Shortness of breath or trouble breathing
  • Weight loss
  • Fatigue

FDA Actions

As the number of adverse event reports involving Limbrel rose, the FDA began to take notice and issued a series of safety alerts to consumers and their doctors. The first safety alert was released on Nov. 21, 2017 and said the agency was investigating Limbrel and its manufacturer, Primus Pharmaceuticals Inc., of Scottsdale, Arizona. At least two other safety alerts have been released since then and the FDA is asking Primus to take Limbrel off the market.

Safety Alerts

The FDA has issued at least three to four safety alerts related to Limbrel and potentially life-threatening health conditions. On Nov. 21, 2017, the FDA issued its first safety alert, telling consumers and doctors the agency was investigating a rise in adverse event reports involving Limbrel. The agency said the number of reports began to increase in September 2017 and by Nov. 21, 2017, the FDA had received 194 reports.

A wide range of adverse events were reported, but the agency said many of the reports detailed two life-threatening medical conditions related to Limbrel: drug-induced liver injury and hypersensitivity pneumonitis.

Of the 194 reports the agency received, 57 contained enough information to analyze in detail whether or not Limbrel was associated with the adverse event; 30 of those reports were able to be analyzed using a causality assessment to determine the likelihood that an association existed between taking Limbrel and the adverse event.

The agency said it contacted Primus Pharmaceuticals on Nov. 8, 2017 regarding the adverse events and to request more information about Limbrel. While Limbrel is regulated by the FDA, it it not considered a pharmaceutical drug and, therefore, was not approved using the more rigorous approval process necessary to bring a new drug to market.

In the Nov. 21 safety alert, the FDA recommended patients stop using Limbrel immediately and consult their physician. It also told consumers to work with their doctors to report adverse events potentially associated with Limbrel to the FDA, especially if they experienced drug-induced liver injury or hypersensitivity pneumonitis.

In early December 2017, the FDA issued updated safety alerts to inform consumers and their doctors about the steps the agency was taking regarding Limbrel. The agency said it asked Primus to initiate a voluntary recall of Limbrel to take it off the market, but as of Dec. 7, 2017, the company had not acted upon its recommendations.

Voluntary Recall

The FDA is calling on Primus Pharmaceuticals, the maker of Limbrel, to take its product off the market. The FDA’s call to action is in response to a rise in adverse events related to Limbrel. Many of these adverse events include the life-threatening medical conditions drug-induced liver injury and hypersensitivity pneumonitis.

Despite the FDA’s warnings, Primus has not moved to recall Limbrel. Still, the agency warns consumers not to use Limbrel because of the risk of drug-induced liver injury and hypersensitivity pneumonitis.

In an update to its initial Nov. 21 safety recall, the FDA wrote:

“The U.S. Food and Drug Administration recommended that Primus Pharmaceuticals, Scottsdale, Arizona, voluntarily recall Limbrel, a capsule marketed to manage the metabolic processes associated with osteoarthritis. The company has not yet acted to remove the product from the market. Although the product is marketed as a medical food, the preliminary determination of the FDA investigation is that Limbrel is an unapproved new drug. The agency does not have mandatory recall authority over drug products.”

The FDA continued:

“Consumers taking any Limbrel products should stop immediately and contact their health care provider. Health care providers who are aware that their patients are taking Limbrel should advise them to stop using it.”

Until Primus heeds the FDA’s warnings to recall Limbrel, a potentially dangerous medical product will remain on the market.

What Does Primus Say?

The maker of Limbrel, Primus Pharmaceuticals Inc., maintains the safety and effectiveness of its product, despite the FDA’s recommendation to take it off the market.

On its website, Primus says the ingredients in Limbrel are safe according to strict FDA standards, yet it is the FDA that is asking Primus to remove Limbrel from commerce because of safety concerns.

Primus writes:

“Limbrel’s ingredients have GRAS (Generally Recognized As Safe) status according to strict FDA standards. For an ingredient to achieve GRAS status the requirements include a technical demonstration of non-toxicity and safety as well as general recognition and agreement on that safety by experts in the field. Foods for general consumption in the U.S. hold GRAS status and are therefore considered safe for public consumption. Many food additives with widely accepted therapeutic benefits have been approved as GRAS ingredients such as Folic acid, Vitamin C and Calcium.”

The pharmaceutical company goes on to say that human and animal studies have shown Limbrel’s side effects are comparable to placebo. “To date, the number of product complaints and adverse events about Limbrel from either physicians or patients has been very low compared to most other prescription products,” the company wrote on its website.

This seems to ignore the adverse event reports submitted to the FDA, which show Limbrel is associated with life-threatening conditions, including drug-induced liver injury and hypersensitivity pneumonitis. It also flies in the face of the FDA’s recommendations, which implore Primus to remove Limbrel from market.

What is Osteoarthritis

Limbrel is marketed as a medical food that helps patients with osteoarthritis by regulating the metabolic processes associated with the condition. Primus boats that Limbrel provides the necessary nutrients for patients with osteoarthritis which they can’t otherwise get through their diet alone.

Osteoarthritis is the most common form of arthritis and affects millions of people around the world. Osteoarthritis occurs when the cartilage on the ends of your bones wears down over time. That cartilage normally protects bones from rubbing up against each other, and as it breaks down, movement becomes stiff and painful.

Osteoarthritis can affect any joint in the body, but typically affects joints in your hands, knees, hips, and spine. The symptoms of osteoarthritis can be managed by maintaining a healthy lifestyle, but the underlying process of the disease can never be reversed.

Symptoms of Osteoarthritis

The symptoms of osteoarthritis can develop slowly and typically get worse over time. Signs and symptoms of osteoarthritis include:

  • Pain in the joints, during or after movement
  • Tenderness in the joints when light pressure is applied
  • Stiffness, especially in the morning or after being inactive
  • Loss of flexibility
  • Grating sensation that you hear or feel in the joint
  • Bone spurs, or extra bits of bone that feel like hard lumps and form around the affected joint

Risk Factors

Osteoarthritis occurs when the cartilage that cushions the ends of the bones in the joints gradually deteriorates. In osteoarthritis, the normally slick surface of the cartilage becomes rough and can eventually wear down completely, leaving bone to rub against bone.

There are several risk factors that increase a person’s chance of developing osteoarthritis. These risk factors include:

  • Older age – the risk of osteoarthritis increases with age
  • Sex – women are more likely to develop osteoarthritis over men
  • Obesity – carrying extra body weight puts added pressure on the joints and fat tissue produces proteins that may cause harmful inflammation in and around the joints
  • Joint injuries – sport-related injuries or injuries that occur from an accident may increase the risk of osteoarthritis
  • Certain occupations – jobs that place repetitive stress on a certain joint may increase the risk of osteoarthritis developing in that joint
  • Genetics – the tendency to develop osteoarthritis can be passed down
  • Bone deformities – people born with malformed joints or defective cartilage may have an increased risk of osteoarthritis

Maintaining a healthy lifestyle can reduce a person’s risk of developing osteoarthritis or slow the process once it starts. This includes staying active and maintaining a healthy weight.

10 Dos and Don’ts for Managing Osteoarthritis Knee Pain

Limbrel Lawsuits

Schmidt National Law Group is currently looking into potential litigation against the manufacturer of Limbrel, Primus Pharmaceuticals. People suffering from osteoarthritis who took Limbrel and developed drug-induced liver injury or hypersensitivity pneumonitis are urged to speak with an attorney, as they may be entitled to financial compensation. There may be significant rewards in the form of cash settlements and payouts to those affected.

Call Schmidt National Law Group today at 800-631-5656 to speak with one of our experienced lawyers and to see if you qualify for a potential Limbrel lawsuit.

Get Expert Legal Help Now

  • This field is for validation purposes and should be left unchanged.

Sources

American Lung Association. “Learn About Hypersensitivity Pneumonitis.” Retrieved from:

http://www.lung.org/lung-health-and-diseases/lung-disease-lookup/hypersensitivity-pneumonitis/learn-about-hypersensitivity.html

U.S. Food and Drug Administration. “Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory – Linked to Potentially Life-Threatening Health Problems.” Published Nov. 21, 2017, updated

Dec. 5, 2017. Retrieved from: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586111.htm

U.S. Food and Drug Administration. “FDA Alerts Consumers About Potentially Life-Threatening Health Problems Linked to Limbrel.” Published Dec. 7. 2017. Retrieved from:

https://www.fda.gov/Food/RecallsOutbreaksEmergencies/SafetyAlertsAdvisories/ucm585992.htm

Mayo Clinic. “Osteoarthritis.” Updated Aug. 16, 2017. Retrieved from: https://www.mayoclinic.org/diseases-conditions/osteoarthritis/symptoms-causes/syc-20351925

Primus Pharmaceuticals Inc. “Limbrel’s Safety.” Retrieved from: http://www.limbrel.com/about/safety.php

Primus Pharmaceuticals Inc. “What is Limbrel?” Retrieved from: http://www.limbrel.com/about/limbrel.php

 

//]]>