NEJM publishes counterfeit bevacizumab details

More details from the case of counterfeit copies of Roche's Avastin (bevacizumab) causing eye problems in China have been revealed in correspondence published in the New England Journal of Medicine (July 28).

A letter from Xiaodong Sun, a doctor at Shanghai First People's Hospital where the fake drug was administered off-label to treat age-related macular degeneration (AMD), notes that 116 patients (70 men and 46 women) were given treatment from three vials of bevacizumab.

Intraocular inflammation was diagnosed in 80 patients in this group, and a subsequent investigation by Roche and local health authorities found no active ingredient, but also no microbial contamination.

Initially it was thought that the inflammation may have been caused by contamination with bacteria or fungi, but now a non-infectious cause is suspected, although the exact nature of this has not been established.

The letter notes that both bevacizumab - and another product from Roche called Lucentis (ranibizumab) specifically approved for AMD - are both at risk of being replaced with counterfeit drugs.

"Vigilance is needed on the part of physicians, drug distributors, and government oversight agencies," writes Dr. Sun.