The first medication to take care of diarrhea in people with HIV/AIDS who take antiretroviral medications has been approved by the U.S. Food and Drug Administration.
Fulyzaq (crofelemer) is sanctioned for individuals whose diarrhea isn't caused by an infection or gastrointestinal disorder but by the antiretroviral medications used to combat HIV/Helps, the FDA said in a news release. The drug comes from the crimson sap of the Croton lechleri plant.
Fulyzaq's safety and efficiency were evaluated in a clinical research involving 374 individuals who were HIV-positive, on steady drug therapy and who had had diarrhea for just one month or much longer. About 17.6 percent of people who took Fulyzaq had a positive "clinical response," compared with a positive response among 8 percent of people who took a placebo.
All individuals in the analysis were tested to confirm that their symptoms were not caused by an infection or gastrointestinal disease, the FDA said. Common side effects to Fulyzaq's make use of were upper respiratory tract infection, bronchitis, cough, flatulence and an increase in the liver enzyme bilirubin.
The drug is written by Salix Pharmaceuticals, based in Raleigh, N.C.
