FDA approves botanical prescription drug for antiretroviral patients

The U.S. Food and Drug Administration recently approved the drug Fulyzaq, or crofelemer, to help HIV/AIDS patients relieve diarrhea caused by antiretroviral therapy.

Diarrhea is a common side effect of antiretroviral therapies and is a common reason why HIV/AIDS patients discontinue their use or switch to other antiretrovirals. Fulyzaq was approved to only treat diarrhea that is not caused by a viral, bacterial or parasitic infection. It is taken twice a day to stop the secretion of electrolytes and water into the gastrointestinal tract.

"Currently, there are no FDA-approved therapies for HIV-associated diarrhea," Dr. Julie Beitz of the FDA's Center for Drug Evaluation and Research said. "Fulyzaq may be helpful to HIV/AIDS patients with this troublesome condition."

Fulyzaq is derived from the bright red sap of the dragon's blood, a flowering plant found in northwestern South America. It is only the second botanical prescription drug approved by the FDA.

Botanical drugs refer to those produced from one or more plants with varying degrees of purification. As with other types of drugs, botanicals are tested for both safety and efficacy before being approved. In addition, the drug's producers must be able to ensure quality control of raw materials, agricultural processes and collection methods.