In the midst of an opioid epidemic that is killing nearly 100 people every day, the FDA has taken action against a natural medical food that offers patients an alternative to opioids. Last November, the FDA posted a warning on its website concerning Limbrel, a medical food marketed by Primus Pharmaceuticals for the management of osteoarthritis. Then, in December, the agency recommended that Primus voluntarily recall Limbrel. The stated reason for the warning is that the FDA is investigating serious adverse events involving Limbrel. In a letter to Primus, the FDA states that 194 adverse event reports for Limbrel were received between 2007 and 2017—about 20 a year. Consider that NSAIDs (non-steroidal anti-inflammatory drugs), an alternative treatment for arthritis, cause approximately 107,000 hospitalizations every year, along with an estimated 16,500 deaths among arthritis patients alone. Limbrel’s two main ingredients are Chinese skullcap and catechin, a flavonol and antioxidant found in blueberries and other fruits, as well as brewed tea, chocolate, and red wine. Chinese skullcap has been used safely in traditional Chinese medicine for many, many years.

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