Roche Cooperates With Inquiry Into Off-Label Avastin Use
Roche says it is cooperating with inquiries from the Indian states of Gujarat and Telangana, where sales of its cancer drug Avastin were halted after 15 patients experienced pain and swelling in their eyes.
The patients had received Avastin for vision problems, although the medication was not approved for that purpose. Avastin has been used off-label worldwide to treat advanced age-related macular degeneration.
The affected patients already have undergone surgery after they reported vision ailments following treatment with Avastin. A hospital said it has administered the drug to more than 7,000 people over the past decade, but it has stopped its usage.
After Gujarat placed an alert, Telangana, in southern India, also ordered a freeze on Avastin sold in that state. Both states are investigating.
"Roche will cooperate fully with any investigations undertaken by the authorities. We are taking the events in Gujarat very seriously," the company tells DID. The Roche India unit also has launched an internal inquiry into the matter.
“Avastin is not developed and manufactured to meet intraocular standards,” Roche says in a statement, noting that off-label use of the drug “bears the risk of contamination and has already led to serious bacterial infections of the eye in other countries around the world.”