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"The safety of patients is of the utmost importance to Genentech, and we continue to monitor and report to FDA adverse event reports from patients and physicians," Tara Cooper said in a statement.
A spokeswoman for Abbott, based in North Chicago, Ill., said the language on heart rhythm risks already appears in Norvir's labeling. The company previously completed the same studies FDA requested of Genentech, and updated its drug's label in August 2008.
HIV attacks the body's immune system, eventually causing AIDS. Just over 1.1 million Americans are estimated to have HIV and 232,000 do not know it, according to the Centers for Disease Control and Prevention.
The FDA issued Tuesday's warning under its so-called early communication program, which seeks to alert the public to a potential side effect with a drug immediately, even if no direct link has been established.
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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