There is a new prescription medication on the market that excites me. The name of the medication is Limbrel (Flavocoxid). Flavocoxid is a blend of flavonoids, which are antioxidants commonly found in fruits, vegetables, and other foods. Flavonoids are part of another group of compounds called polyphenols. Large amounts of polyphenols are found in fruit skins and are believed to be a primary reason for the health benefits of many fruits and vegetables.
In addition to containing these antioxidants, Limbrel blocks the same inflammatory proteins as ibuprofen and other NSAIDs (non-steroidal anti-inflammatory drugs) as well as other inflammatory proteins. It does this by having dual inhibition of the COX and LOX enzymes. The COX-1 and COX-2 enzymes are the ones that NSAIDs inhibit. Essentially, COX and LOX enzymes set off chemical chain reactions that result in inflammation. Blocking these chemical cascades can reduce inflammation.
What may be most unique about Limbrel is the Food and Drug Administration (FDA) labeling it as a "medical food" product. In the 1988 Orphan Drug Act, Congress defined a "medical food" as a "food that is formulated to be consumed or administered...under the supervision of a physician, and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."
Sound confusing? It needn't be. Just remember that a medical food is not just any food that may have nutritional benefits. A medical food is designed and intended for the treatment of a specific condition and it is prescribed by your doctor. You can't just pick it up at your local grocery store.
The ingredients in Limbrel are food-based and safely consumed in many foods. In accordance with the Orphan Drug Act and Amendments, Limbrel is marketed by Primus Pharmaceuticals as a product that addresses the "nutritional needs" of patients with osteoarthritis.
The question then arises, if it is food-based, why not just eat an anti-inflammatory diet? Wouldn't that accomplish the same ends? Certainly, eating an anti-inflammatory diet is ideal. For those people following an anti-inflammatory diet, this pill gives that diet a boost and may help further reduce inflammation. The advantage of this pill as opposed to a drug such as an NSAID is that it is presumably safer and better tolerated. Of course, only your doctor can tell you if Limbrel or any other medical food or drug is right for you.
Why I'm Excited About Limbrel
As a doctor who stresses the importance of nutrition in treating osteoarthritis as well as other conditions, I believe this is a long overdue and exciting focus for a pharmaceutical company to take.
How is a medical food different from a supplement?
From an important practical perspective, unlike supplements in this country, prescription medical food is subject to the more rigorous monitoring of the FDA. The product must contain just what the label says it does. Likewise, medications -- including medical foods -- must be proven both safe and effective by the manufacturer before they can be sold to the public.
Because the supplement industry is not subject to the same regulation, studies indicate that many supplements advertise one thing but are, in fact, filled with another substance that isn't advertised. (That is one reason why it is so important to only buy supplements from a reputable company with a good track record!) Supplement makers also don't have to prove that their product is either safe or effective before selling it.
But this doesn't mean that Limbrel will work for you. The evidence regarding the efficacy of Limbrel for the treatment of osteoarthritis symptoms is still in its early stages. While preliminary studies appear promising, more studies are needed to offer true, evidence-based recommendations regarding its efficacy for the treatment of osteoarthritis in different joints. Limbrel side effects appear to be comparable to taking placebo (sugar pill). Still, it is a plant product and gastrointestinal upset can occur. Also, while it appears from early data that taking Limbrel in combination with other medications (such as warfarin) appears to be safe, more studies are needed.
If you're curious about the product, ask your doctor about it and reference this article. Be sure to tell your doctor all your medications and medical conditions when discussing if Limbrel is appropriate for you.
Why Limbrel Could Be Important
While more research is needed, there are many potential advantages of a product like Limbrel. As I discuss in my book, The Arthritis Handbook: Improve Your Health and Manage the Pain of Osteoarthritis, an anti-inflammatory, antioxidant diet helps with the inflammation associated with osteoarthritis -- and it is also good for your overall health! Limbrel is high in antioxidants. This has many potential health benefits that may extend beyond osteoarthritis (of course it is important to recognize and remember that this is not what it is marketed for).
It may take up to two or three weeks before someone taking Limbrel notices a difference, if any. In my practice, if it has not helped after four weeks, I discontinue it in my patients. Anecdotally, I have used Limbrel for about one year with many of my patients and have had good success. Is Limbrel right for you? Again, only your doctor can help you with that. As this is a relatively new tool in the treatment of osteoarthritis, I would encourage you to discuss it with your doctor.
I hope that Limbrel is only the beginning of a larger re-focusing of pharmaceutical companies toward a "medical food model." I don't know if it is, but in the meantime, at least there are a few medical foods that are available to help people with various ailments.
I wish you the best of health because with good health, all things are possible.
Published On: August 29, 2008