First Herb Ever Approved by the FDA

For the first time ever, the FDA has approved an orally administered herb. Corfelemer (Fulyzaq), derived from the South American herb sangre de drago (which is available in Canada), has been approved by the FDA for the diarrhoea commonly experienced by people with HIV/AIDS on antiretroviral therapy. . . . 

The approval was based on a study that showed clinical response in 17.6% of HIV patients compared to only 8% in patients given a placebo. Fulyzaq is the only therapy approved by the FDA for this use (FDA News Release, “FDA approves first anti-diarrheal drug for HIV/AIDS patients,” December 31, 2012).

While several botanicals have been approved for over-the-counter use, this is the first time the FDA has approved a botanical for prescription. The new drug is an isolated and purified component derived from the latex of the tree.

The tree is called sangre de drago, or dragon’s blood, because when the bark of the tree is slashed, it exudes a blood red sap. The sap is rich in proanthocyanidin antioxidants. Though the proanthocyanidins are believed to be the active ingredient responsible for the anti-diarrhoea effect, though there may be other active ingredients as well.

The research cited by the FDA is not the first to show the promise of sangre de drago for serious diarrhoea, including the diarrhoea of AIDS. A number of double-blind studies have found that sangre de drago, given to people with HIV and chronic diarroea, is able to significantly reduce stool weight and frequency (Amer J Gastroenterol 1999; Koch J. 2000). Another double-blind study found that the herb was able to significantly help traveler’s diarrhoea.

In Peru and other parts of South America, sangre de drago has many other traditional uses. Itis used topically for wound healing and open sores to both stop the bleeding and disinfect the wound. It is also used for infected gums and the pain of cavities, flu, intestinal disorders, dysentary, infertility, cancer, ulcers, lung problems, cough, herpes, diabetes, rheumatism, inflammation.