FDA Strengthens Warning Label On Roche HIV Drug

Law360, New York (October 21, 2010, 7:06 PM EDT) -- The U.S. Food and Drug Administration has beefed up the warning label for Roche Holding AG's HIV treatment Invirase, cautioning patients and doctors that when used in combination with Abbott Laboratories Inc.’s HIV drug Norvir, a potentially life-threatening heart abnormality could result.

On Thursday the FDA said it is also requiring Roche to produce a medication guide for patients using Invirase that would describe the risks of taking the drug in combination with Norvir in detail, and clarify that in some cases it could cause changes...
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