Limbrel Prescription Botanical Medical Food

Anti-Inflammatory Medical Food

Arthritis of the knee xray
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Limbrel is the brand name of flavocoxid, a prescription "botanical medical food." It is made from a combination of root and bark extracts from plants. The plant extracts contain substances called flavonoids in a high concentration you couldn't get through a normal diet.

Some of these same flavonoids are found in medicinal Chinese green tea, used in the treatment of a variety of medical conditions for a long history.

They are also found in kale, cocoa, apricots, cauliflower, soy and peanutes. In Limbrel, the main flavonoids are baicalin and catechin. As a medical food, Limbrel is not available to the general public but instead is prescribed for patients whose conditions may be treated by it. The current indication for Limbrel is in the management of osteoarthritis.

How Limbrel Works:

The flavonoid extracts found in Limbrel appear to have anti-inflammatory properties by inhibiting enzymes that cause inflammation. These enzymes, called COX (cyclooxygenase) and LOX (lipooxygenase) create molecules that cause inflammation and pain.

Limbrel prevents the production of these enzymes and therefore decreases the inflammation these enzymes would cause. It does not have the selective COX-2 inhibition that some other arthritis medications have. With the dual action on COX and LOX, there are fewer side effects on the stomach lining, heart or kidneys.

Who May Be Prescribed Limbrel?

The current indication for prescribing Limbrel is in the clinical dietary management of the metabolic processes of osteoarthritis. It may be prescribed for mild to severe osteoarthritis. It should not be given to peple who have an allergy to flavocoxid or flavonoids. If you are allergic to foods that are normally high in these substances, such as green tea, dark chocolate, red wine or Brazil nuts your doctor may decide not to prescribe Limbrel.

It hasn't been formally studied for people under age 18 or pregnant or breastfeeding women, so it's not recommended for those people.

The Usual Dose of Limbrel:

Limbrel  and Limbrel500 are given orally as a tablet, twice per day. There are two formulations, 250 mg and 500 mg. Both also have 50 mg of citrated zinc bislycinate. Limbrel is a prescription medicinal food that should be used under a doctor's supervision.

Side-Effects of Limbrel:

The FDA classifies Limbrel as a medical food. It is given as a prescription, but these foods have been "generally recognized as safe" by the FDA. However, medical foods do not undergo the same formal safety and effectiveness testing as drugs must pass before they are put on the market. They continue post-marketing surveillance for interactions and side effects.

Limbrel has not been found to have the side-effects seen with nonsteroidal anti-inflammatory medications (NSAIDs), including the problems with the formation of stomach ulcers. Limbrel has side-effects similar to a placebo (sugar pill).

A study found it as effective as naproxen but with better safety for gastrointestinal, renal and respiratory side effects.

Four cases of acute liver injury associated with Limbrel were reported in a 2010 study.

Differences Between Medical Foods and Dietary Supplements:

The words "medical food" and "dietary supplement" differ in their regulation by the FDA.

A medical food:

  • provides nutritional support for a specific disease or condition,
  • and is intended to be used under a physician's supervision.

The key is that "medical foods" are designed to manage a specific disease or condition (e.g. Limbrel for arthritis), whereas "dietary supplements" are designed to support the healthy function of a part of the body (e.g. glucosamine for cartilage health).

Sources

Martel-Pelletier J, et al. "Therapeutic role of dual inhibitors of 5-LOX and COX, selective and non-selective non-steroidal anti-inflammatory drugs." Ann Rheum Dis. 2003 Jun;62(6):501-9.

Leval X, et al. "New trends in dual 5-LOX/COX inhibition." Curr Med Chem. 2002 May;9(9):941-62.

Limbrel.com, accessed 3/13/2016

N. Chalasani, R. Vuppalanchi, V. Navarro, R. Fontana, H. Bonkovsky, H. Barnhart, D.E. Kleiner, and J.H. Hoofnagle. “Acute Liver Injury due to Flavocoxid (Limbrel), a Medical Food for Osteoarthritis. A Case Series.” Annals of Internal Medicine 19 June 2012(volume 156, pages 857-860).

Levy RM, Khokhlov A, Kopenkin S, Bart B, Ermolova T, Kantemirova R, Mazurov V, Bell M, Caldron P, Pillai L, Burnett BP. "Efficacy and safety of flavocoxid, a novel therapeutic, compared with naproxen: a randomized multicenter controlled trial in subjects with osteoarthritis of the knee." Adv Ther. 2010 Oct;27(10):731-42. doi: 10.1007/s12325-010-0064-z

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