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The U.S. Food and Drug Administration announced Monday that drug company Genentech Inc. will be adding stronger label warnings on their blockbuster cancer drug Avastin, which will warn about the increased risk of a rare brain condition in patients using the drug.
The condition called posterior leukoencephalopathy syndrome (RPLS) can cause numerous complications such as blindness and other serious impairments.
The current drug label includes information about recent reports of several patients using Avastin who developed septum perforations—holes within the nose. The new label will alert doctors and patients that there have been confirmed reports of RPLS in patients taking the drug in clinical trials.
Genentech will continue to conduct future studies testing various side effects. “For future clinical studies of Avastin, these two things we we''ll look for,” said company spokeswoman Kristina Becker, about the brain condition and nose condition.
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