Limbrel Capsules Deemed by the FDA as an Unapproved Drug

The Food and Drug Administration (FDA) has suggested that use of the product known as Limbrel may inflict a life-threatening injury to the liver in addition to promoting the development of pancreatitis and hypersensitivity pneumonitis.

In November 2017, the FDA issued a warning concerning Limbrel, which Primus Pharmaceuticals, the company that markets the product, designates as a “medical food” designed for the treatment of osteoarthritis. Subsequently, in December, the agency recommended that the company recall Limbrel on a voluntary basis. This recommendation was precipitated by the agency’s investigation into a series of adverse events involving the use of the product.

The FDA informed Primus that it had recorded 194 adverse event reports surrounding the use of Limbrel between 2007 and 2017.

What is Limbrel?

Distributed in capsule form, Limbrel comes in two doses – Limbrel250 and Limbrel500. The product contains two distinct flavonoids, baicalin (derived from Scutellaria baicalensis) and catechin (derived from Acacia catechu). The product also contains zinc.

Limbrel has been advertised as a medical food designed to help “manage the metabolic processes associated with osteoarthritis.” The FDA, however, disagrees and asserts that the product fails to meet the definition of a medical food. The FDA, as mentioned, advised Primus on December 18, 2017 to commence a voluntary recall of its product, which the agency considers a dangerous drug.

Citing “unwarranted pressure” from the FDA, the company voluntarily suspended promotion and sale of Limbrel on Dec. 21, 2017.

In a statement issued on its Limbrel website, Primus Pharmaceuticals stated:

“Limbrel is representative of the type of innovation in nutrition and patient care Congress intended to stimulate when it enacted the statutory definition of a medical food in 1988. If the FDA and industry could work together and the FDA be open to innovation, medical foods provide a great opportunity to advance public health while reducing total costs of care.”

FDA designation of Limbrel

Due to the fact that the FDA designates Limbrel as an unapproved drug, it has informed medical providers that patients should cease from taking the product. The reasons include, according to the FDA, the products potential to inflict liver and lung damage, the latter as a result of hypersensitivity pneumonitis which is a condition that involves inflammation of the alveoli in the lungs.

The FDA has continued investigating the use of Limbrel and its effects. In particular, it is examining samples of the product, its formula, and procedures surrounding the manufacturing of the product.

Proving liability for harm done

If Limbrel has caused damage to your liver or hypersensitivity pneumonitis or any other type of physical harm, you may be entitled to recover compensation. An experienced products liability attorney can help you move forward with your case.

However, before a product manufacturer such as Primus Pharmaceuticals can be held responsible for a products liability claim, certain specific findings must be established.

In this case, the product must be proven to be a defective drug. In other words, it may have been improperly manufactured, it may lack adequate warnings and labeling, or the product may simply be inherently dangerous.

It must also be shown that the defective drug directly cause the injury suffered. If the injury happens to be liver damage, for example, your attorney will have to show that only the product itself and no other explanation is responsible for the damage.

Establishing responsibility and liability in a legal case of this nature can be complicated. However, an experienced products liability attorney can gather the necessary evidence, including medical records, company records, and medical expert testimony to support your claim for compensation.

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