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FDA Adds New Warnings to Avastin

Sep 26, 2006 | Medscape

Genentech Inc. has added warnings about a rare brain condition called reversible posterior leukoencephalopathy syndrome, or RPLS, in patients using its cancer drug Avastin, the Food and Drug Administration said.

The drug's label also now includes information about seven reports of patients who developed holes inside the nose called septum perforations, the FDA said on its website.

Genentech said in March it was working to include the information on the prescribing label while it reviewed data about the frequency of the brain condition.

According to a letter in the New England Journal of Medicine in March, two women developed RPLS while taking the blockbuster drug. Both later recovered from the condition, which can cause blindness and other complications. In a letter sent to doctors this month, Genentech said it received reports of confirmed and possible RPLS in Avastin patients participating in clinical studies at a rate of less than 0.1 percent.

``For future clinical studies of Avastin these are two things we we'll look for," said a Genentech spokeswoman, Kristina Becker, referring to the brain and nose conditions. She added that the company had finished reviewing its current data.


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