Natural Osteoarthritis Treatment Linked to Acute Liver Injury

osteoarthritis medical food limbrel flavocoxid acute liver injury

Could your natural osteoarthritis medication cause acute liver problems?

A prescription medical food used to treat osteoarthritis has been linked to acute liver injury in a series of cases according to a paper published yesterday in ant Annals of Internal Medicine. Dr. Naga Chalasani and colleagues at the Indiana University School of Medicine, Indianapolis, report on four cases of liver toxicity, three which were deemed highly likely to be connected to this prescribed medical food, and one which is possibly connected. The food in question is flavocoxid, a botanical product used to treat osteoarthritis. Like other medical foods, flavocoxid is not required to pass premarketing trials for safety or efficacy, so these cases constitute an early warning for other patients using flavocoxid for osteoarthritis, a common cause of back pain and spinal stenosis.

Osteoarthritis Treatments – Natural Does Not Mean Safe

Marketed under the brand name Limbrel (Primus Pharmaceuticals), flavocoxid is derived from the bark of Acacia catechu (Mimosa catechu) and the root of Scutellaria baicalensis (Chinese skullcap). Patients and consumers are often led to believe that natural means safe, despite there being a plethora of nutritional supplements, health foods, and herbs that can cause myriad adverse health consequences, particularly when mixed with pharmaceuticals. Flavocoxid is no different, with many patients assuming it to be safe due to its natural origins. This latest research was done as part of the Drug-Induced Liver Injury Network Prospective Study which looked at 877 patients enrolled in the study across eight academic medical centers in the US.


Acute Liver Injury from Flavocoxid

The four patients with acute liver injury developed the issue within three months of commencing treatment with flavocoxid for osteoarthritis and their symptoms included jaundice, itchy skin (pruritis), abdominal pain, fever, and a rash, along with a variety of clinical signs demonstrating liver distress. Highly elevated levels of alanine aminotransferase, alkaline phosphatase, and serum bilirubin in the four patients, who were all women, gave particular cause for concern and required immediate action. A few days after ceasing flavocoxid treatment the patients’ liver difficulties began to abate and all patients’ blood enzyme levels returned to normal within one to three months.

Pain Medications and Liver Injury

limbrel flavocoxid osteoarthritis treatment

Natural spinal stenosis treatments - are they really any safer than pharmaceuticals for treating osteoarthritis?

Three of the four patients are thought highly likely to have suffered acute liver injury as a result of taking flavocoxid for osteoarthritis. The fourth patient had a more complicated case as she was also taking pregabalin, duloxetine, and tizanidine, all potential hepatotoxins, along with flavocoxid. The actual mechanism behind the liver injury from flavocoxid remains unknown, leaving many patients at risk of such problems where they, and their physicians, are unaware of the issue. Patients taking a number of different medications to treat back pain from osteoarthritis, or other chronic pain condition could be considered to be at particularly risk when adding flavocoxid to the mix. Oftentimes, clinical trials assume safety of pharmaceuticals only in isolation, which does not accurately represent common use of these drugs as part of a cocktail of pain medications, anti-inflammatories, anti-depressants, and nervines.

Regulating Medical Foods

The use of flavocoxid for osteoarthritis may not be all that common currently but many more patients are leaning towards more natural treatments for chronic joint pain in light of known side-effects from pharmaceuticals. The sad irony then is that some pharmaceuticals may actually be deemed safer to use for osteoarthritis than natural remedies as the former are at least required to be evaluated in clinical trials before being marketed. Prescription drugs are also required to display safety information about potential side-effects in order to forewarn patients; natural medical foods such as flavocoxid are not subject to such regulation.

Side-Effects of Osteoarthritis Treatment

These four cases may be the beginning of a new raft of identified acute liver injuries from flavocoxid used for osteoarthritis and could, as such, lead to policy changes regarding the sale and marketing of medical foods. In the meantime, patients with spinal stenosis and joint pain caused by wear and tear may wish to talk to their doctor about the potential side-effects of using flavocoxid (Limbrel) for osteoarthritis, and keep an eye out for signs of acute liver distress.

Reference

Naga Chalasani, MD; Raj Vuppalanchi, et al, Acute Liver Injury due to Flavocoxid (Limbrel), a Medical Food for Osteoarthritis: A Case Series, Ann Intern Med. 19 June 2012;156(12):857-860.

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