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Medical News

HIV Drug Linked to Serious Liver Side Effects, Health Canada Warns

May 16, 2008

Canadian health officials and Tibotec, a division of drug maker Janssen-Ortho, are advising patients taking Prezista (darunavir) that serious liver side effects have been linked to the drug. Prezista is used, in combination with ritonavir and other HIV drugs, for patients who have failed other antiretroviral therapy.

Among Prezista patients studied in clinical trials, 0.5 percent developed hepatitis or inflammation of the liver. Since the drug came to market, there have been 13 reported cases of patients taking Prezista developing hepatitis, including two who died. There were in addition 25 reported cases of patients taking Prezista who developed other liver problems, from mid-2006 to the end of 2007, and among whom 14 died.

It is not known whether Prezista contributed to these adverse events and deaths or if they were caused by other medical problems or medications taken by the patients. However, Health Canada said the patients involved all had advanced HIV disease, were taking other medications as well, or had illnesses such as hepatitis B or C infection.

Patients with liver problems are at greater risk of Prezista side effects, the warning says.

Health Canada urges patients taking Prezista to contact their physician immediately if they experience any of the following symptoms: dark urine, yellowing of the skin, abdominal pain (especially on the right side bellow the ribs), general itchiness, decreased appetite, nausea, vomiting or fatigue. Patients should not stop taking Prezista without first consulting their doctor or pharmacist.

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Back to other news for May 2008

Adapted from:
Canadian Press

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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
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