TORONTO - Health Canada and pharmaceutical company Janssen-Ortho are warning people taking the HIV drug Prezista that the drug can cause serious liver side-effects.

Prezista, which is used in combination with another antiretroviral medication known as ritonavir, is used to treat adult patients in whom other HIV therapy has failed.

The warning says that in clinical trials, 0.5 per cent of people who took the drug developed hepatitis or inflammation of the liver.

And since the drug has been brought to market, there have been 13 reports of patients who developed hepatitis, including two who died.

The warnings says that between mid-2006 and the end of 2007 there were also 25 reports of patients who developed other liver problems; 14 of those patients died.

It's not clear if Prezista contributed to the adverse reactions and deaths or if they were due to other medical problems or medications the people were taking.

Health Canada notes the patients involved had advanced HIV disease and were taking other drugs as well, or had other illnesses such as hepatitis B or C infections.

People who have existing liver problems - such as hepatitis B or C - are at greater risk of side-effects from the drug, the warning says.

The department says people on the drug should contact their doctor immediately if they have any of these symptoms: dark urine, yellowing of the skin, abdominal pain (especially on the right side below the ribs), general itchiness, decreased appetite, nausea or vomiting or tiredness. People on the drug should not stop taking it without consulting a doctor or pharmacist.

Prezista is the brand name for the drug darunavir. It is made by Tibotec, a division of Janssen-Ortho.

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