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Published on 26 March 2008

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FDA issues warning over Prezista


Health regulators in the US have issued a warning over a possible link between a Johnson & Johnson drug which is used to treat patients with HIV and potentially fatal liver damage.

The Food and Drug Administration (FDA) said that it had received reports of drug-induced hepatitis in some patients who had been taking Prezista, which is used in combination with another HIV drug ritonavir.

The agency outlined the details of the risks in a message to doctors posted on its website.

Earlier this month, Johnson & Johnson and the FDA added new warnings to Prezista’s label.

The new information indicates that 0.5% of patients in the original trials of the drug showed hepatitis.

Since the drug was approved, the FDA has said it has received additional reports of the liver illness, some of which were fatal.

The agency said that most of the reported problems were recorded in patients with advanced HIV who were taking multiple medications, according to the label.

FDA cleared Prezista in 2006 for use in patients who do not respond to treatment with other antiretroviral drugs.

Copyright © PA Business 2008

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