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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
UNITED STATES: Drug to Treat HIV/AIDS Side Effect Mired in Lawsuit
By Glenn Townes
July 23, 2013
New York Amsterdam News (07.18.2013)

Napo Pharmaceuticals has filed a lawsuit against Salix Pharmaceuticals that has delayed availability of the drug Fulyzaq, which the two firms partnered in 2008 to develop. The US Food and Drug Administration (FDA) approved Fulyzaq in 2012 for the prevention of “excessive” diarrhea, a common side effect of HIV antiretroviral therapy (ART). Salix announced in May that the company was working with FDA to expedite Fulyzaq distribution, and stated in June that the drug was available from Walgreens Specialty Pharmacies. However, many doctors treating HIV-infected people reported that their patients were unable to obtain Fulyzaq at Walgreens or any other pharmacy, according to Napo’s legal representative. Until the legal issues are settled, patients with excessive gastrointestinal adverse reactions to ART will continue to suffer. One such individual is a Washington, DC, resident who reported that he has lived with HIV since the 1980s. He noted that ART successfully reduced his viral load to virtually undetectable levels, but he still had “severe intestinal and bowel issues” because of his drug regimen.