Off-Label Avastin Syringe Recall Issued Due to Eye Infection Risk

A compounding pharmacy that made syringes of Avastin specifically for off-label use to treat age-related macular degeneration (AMD), a condition that the cancer drug has not approved by the FDA to treat, is now recalling those syringes due to a risk of serious eye infection. 

Following at least five reports of eye infections, Clinical Specialties in Georgia issued an Avastin unit dose syringe recall on March 18.

While only one physician’s office reported the infections, the recalled Avastin syringes were distributed in Indiana, Georgia, Louisiana, and South Carolina specifically for the off-label treatment of age-related macular degeneration (AMD) and were packaged in sterile syringes.

The recall affects 79 lots of the Avastin syringes which were distributed from December 18, 2012, until the recall. A complete list of lot numbers and expiration dates is listed in the recall notice.

AMD affects more than 2 million Americans over the age of 50 and is the leading cause of blindness in the United States, according to the American Academy of Ophthalmology. That number is expected to double by 2020 as members of the “baby boomer” generation continue to age.

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.

Avastin received approval to treat breast cancer in February 2008, but had that approval taken away after the FDA determined it was not helping breast cancer patients and exposing them to potential Avastin health risks, which may include severe high blood pressure, heart attacks, heart failure, bleeding and hemorrhaging and the development of perforations in the nose, stomach and intestines.

At a cost of only about $50 per dose when used off-label to treat AMD, Avastin has been commonly used for this purpose, as some studies have suggested that Avastin is equally as effective as Lucentis in treating the eye disease, even though Lucentis costs about $2,000 per dose.

However, concerns were raised in a study conducted four years ago that side effects of Avastin may cause severe eye inflammation when the medication is used to treat AMD in some patients. As a result of concerns about the risks, the Department of Veteran Affairs (VA) suspended use of Avastin to treat eye disease in 2011.

Consumers with questions about the Avastin syringe recall can contact Clinical Specialties by phone at (866) 880-1915, or they can email the company at clinicalrx@bellsouth.net.