Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
Reuters NewMedia - August 26, 2009
* Doctors advised to stop treatment if reaction seen
WASHINGTON, Aug 26 (Reuters) - Johnson & Johnson <JNJ.N> has strengthened a warning about serious skin reactions in patients treated with the company's HIV drug Intelence, U.S. regulators and the company said on Wednesday.
J&J's Tibotec Therapeutics unit updated the warning after reports of one death from a skin reaction known as toxic epidermal necrolysis, and another case of liver failure from a severe reaction, said Tibotec spokeswoman Pam Van Houten. The patient with liver failure recovered.
Intelence has included a warning about the risk of severe skin reactions since it was launched in January 2008, Van Houten said. In clinical trials, the rate of serious skin or allergic reactions was less than 0.1 percent, she said.
Intelence should be immediately discontinued if signs of severe skin or allergic reactions, Tibotec said in a letter to doctors.
The Tibotec letter was posted at
http://www.tibotectherapeutics.com/tibotectherapeutics/documents/INTELENCE_DHCP.pdf.
(Reporting by Lisa Richwine; editing by Gunna Dickson)
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