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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
UNITED STATES: FDA Approves First Anti-Diarrheal Drug for HIV/AIDS Patients
Staff Writer
January 2, 2013
FDA News Release (12.31.12) Aids Weekly Plus

On December 31, the US Food and Drug Administration approved Fulyzaq (Crofelemer) to treat diarrhea symptoms in HIV/AIDS patients currently on antiretroviral therapy (ART). Many ART patients either change or discontinue their therapies because of the resultant diarrhea. Fulyzaq is intended for HIV/AIDS patients whose diarrhea is not caused by infection from a virus, bacteria, or parasite. Derived from the red sap of the Croton lechleri plant, Fulyzaq is only the second botanical prescription drug approved by the FDA—a botanical drug can be a complex mixture derived from one or more plant materials of varying degrees of purity. Currently, there are no other FDA-approved therapies for HIV-associated diarrhea, according to Julie Beitz, MD, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.