Avastin Side Effects May Increase Disability Risks in Infants: Study

The findings of new research suggest that infants given the cancer drug Avastin off-label, to treat eye problems linked to premature birth, may face an increased risk of neurodeveloplental problems and other disabilities. 

Canadian researchers reported that preterm infants born with retinopathy of prematurity (ROP) were at three times the risk of cerebral palsy, bilateral blindness or the need for a hearing aid if they were treated with Avastin, when compared to infants treated with laser surgery. The findings were published in this month’s edition of Pediatrics.

The study used data from the Canadian Neonatal Network and the Canadian Neonatal Follow-Up Network databases, looking at 125 infants born before 29 weeks of gestation in 2010 and 2011, who were treated for ROP. Researchers looked at the neurodevelopmental outcome at 18 months using a neurologic examination and the Bayley Scale of Infant and Toddler Development Third Edition.

Avastin (bevacizumab) was approved by the FDA in 2004 for treatment of non-small cell lung cancer and colorectal cancer when combined with chemotherapy. It was developed by Genentech, which was later acquired by Roche. The drug works by restricting blood flow to tumors; starving them. Avastin sales reached nearly $6 billion in 2009.

Although Avastin is not approved by the FDA to treat retinopathy of prematurity (ROP), it is often used off-label to treat certain types of eye problems, such as age-related macular degeneration.

The findings indicate that of the 125 infants treated for eye problems, 27 were treated with Avastin and 98 were treated with laser surgery. Researchers found that infants given Avastin were 3.1 times more likely to suffer neurodevelopmental disabilities than those treated with a laser. That estimate accounts for a number of factors such as gestational age, gender, and severe brain injuries.

“Preterm infants treated with bevacizumab versus laser had higher odds of severe neurodevelopmental disabilities,” the researchers concluded. “Further investigation on the long-term safety of antivascular endothelial growth factor treatment of ROP is needed.”

There were already concerns about the use of Avastin to treat age-related macular degeneration over the last few years, following reports of eye infections that led to blindness and brain damage in some patients. However, the researchers in the latest study did not draw a correlation between those infections and the neurodevelopmental disabilities in preterm infants given the drug, which also included vision problems and brain damage in the form of cerebral palsy.