Processing Magazine

FDA Issues Warning on J&J''s HIV Drug

March 24, 2008
According to the Associated Press, health regulators have warned doctors about a possible link between a Johnson & Johnson HIV drug and potentially fatal liver damage.

The Food and Drug Administration said recently it has received reports of drug-induced hepatitis in patients taking J&J''s Prezista, which is used in combination with another HIV drug ritonavir.

The agency highlighted the risks in a message to doctors posted on its Web site.

J&J and FDA added new warnings to Prezista''s label earlier this month.

The new labeling indicates that 0.5 percent of patients in the original trials of the drug showed hepatitis. Since the drug was approved, FDA has received additional reports of the liver illness, some of which were fatal.

Most of the reported problems were in patients with advanced HIV who were taking multiple medications, according to the label.

FDA cleared Prezista in 2006 for use in patients who don''t respond to treatment with other antiretroviral drugs.