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 U.S. Food and Drug Administration said on Monday.

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

San Francisco, California-based 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 the March issue of the New England Journal of Medicine, 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.


Representatives for the drugmaker could not be immediately reached for comment.

Genentech shares were off 4 cents at $78.43 in late afternoon trading on the New York Stock Exchange.

Swiss drug maker Roche Holding AG is the majority owner of Genentech and markets Avastin outside the United States.