J&J Subsidiary, FDA Warn Against Death, Liver Damage Risk For People Taking Antiretroviral Prezista

Main Category: HIV / AIDS
Also Included In: Regulatory Affairs / Drug Approvals;  Primary Care / General Practice;  Liver Disease / Hepatitis
Article Date: 14 Mar 2008 - 8:00 PDT

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FDA and Johnson & Johnson subsidiary Tibotec have issued a warning about the risk of liver damage and death for people taking the antiretroviral drug Prezista, the Wall Street Journal reports.

In a letter posted on FDA's Web site Wednesday, Tibotec said that it has received reports of liver injury and some deaths since the drug was approved in June 2006 (Wall Street Journal, 3/13). The letter also was sent by Tibotec to doctors this month, Reuters reports (Heavey, Reuters, 3/12). In addition, the company has received reports of 15 cases of drug-induced hepatitis among 3,063 clinical trial participants, according to the letter (Wall Street Journal, 3/13).

Tibotec spokesperson Pam Van Houten said 15 cases of liver problems were reported during clinical trials. Most of the cases occurred among participants with advanced HIV, who were taking a number of medicines, as well as those who were living with hepatitis B or C, the letter said. The letter noted that the problems have not been linked directly with Prezista, which was given in combination with Abbott Laboratories' antiretroviral ritonavir.

Van Houten added the company did not provide information about postmarketing cases reported after the drug's approval. The company did not say how many liver-related deaths have occurred. Van Houten said that Tibotec is issuing a new warning on the drug's label (Reuters, 3/12).

The warning letter is available online.

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