Roche Responds to Avastin Problem in India

FDA News reports that Roche is cooperating with inquiries from the Indian states of Gujarat and Telangana, where sales of its cancer drug Avastin have been halted after 15 patients experienced adverse effects.

It was reported a week ago that Gujarat and Telangana had put sales of Avastin on hold while they investigated further. Patients in these regions had received Avastin for vision problems. While the drug was not approved for this purpose, it has been used off-label worldwide to treat advanced age-related macular degeneration.

Roche has since said in a statement that off-label use of Avastin “bears the risk of contamination and has already led to serious bacterial infections of the eye in other countries around the world.”