January 2013

FDA Approves Botanical Drug

The U.S. Food and Drug Administration (FDA) recently approved crofelemer (Fulyzaq™) to treat diarrhea symptoms associated with antiretroviral therapy for HIV/AIDs.

This is only the second botanical prescription drug to be approved by the FDA. Sinecatechins (Veregen®) was approved as a treatment for external genital and perianal warts in 2006.

Although current antiretroviral drugs cannot cure HIV/AIDS, they may suppress the virus, even to undetectable levels. Individuals taking antiretroviral drugs frequently experience side effects such as nausea and diarrhea. According to the statement issued by the FDA, taking crofelemer (Fulyzaq™) twice daily may relieve the associated diarrhea side effects.

Crofelemer (Fulyzaq™) is derived from the red sap of the Croton lechleri plant, also called Sangre de grado. Sangre de grado (the Peruvian name) or sangre de drago (the Ecuadorian name), meaning "blood of the dragon," is a medium-sized tree that grows in the upper Amazon region of Peru, Ecuador, and Colombia. It has large, heart-shaped, green leaves and greenish-white flowers. Upon injury to the bark of the tree, a dark red resin spills out of the tree. Sangre de grado is still used in traditional medicine in South America, where it is used for hemorrhaging and wounds, and as an antiseptic. It is also used for protection against ulcers, including those of the stomach, mouth, throat, and intestines; as an antiviral, anticancer and antidiarrheal agent; and topically for skin conditions and insect bites.

For more information about sangre de grado, please visit Natural Standard's Foods, Herbs & Supplements Database.


  1. Natural Standard: The Authority on Integrative Medicine. 
  2. U.S. Food and Drug Administration.

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