Hoffmann-La Roche Limited has recalled Avastin (bevacizumab) following cases of necrotizing fasciitis, some fatal, reported in patients receiving the chemotherapy drug in both clinical trials and in the post-marketing setting.
Necrotizing fasciitis is a rare, life-threatening infection of the soft tissue ,with rapidly spreading necrosis of superficial fascia and subcutaneous tissue. Necrotizing fasciitis is commonly known as flesh-eating disease or flesh-eating bacteria syndrome.
Patients diagnosed with diabetes or who are immunocompromised are at greatest risk of developing necrotizing fasciitis. Roche recommends that Avastin be discontinued and appropriate therapy promptly initiated should a diagnosis of necrotizing fasciitis be received.
Avastin is an injectable cancer medication that works by blocking a protein important for the formation of blood vessels. Tumors rely on blood vessels to receive the nutrients they need to survive; Avastin is believed to work by preventing the formation of new blood vessels that feed the tumor and is approved to treat brain, colorectal, lung, and kidney cancers.
According to Roche, it conducted a comprehensive safety review that identified 52 serious case reports of necrotizing fasciitis between November 1997 and September 2012, worldwide; 17 cases involved patient deaths.
The reported necrotizing fasciitis cases occurred in patients taking Avastin in several cancer indications: 2/3rds were being treated for colorectal cancer; 21 patients had gastrointestinal perforation, fistula formation, or wound healing complications preceding the development of necrotizing fasciitis; and all of the patients were receiving additional chemotherapies other than Avastin. Some patients had no other risk factors.
Hoffmann-La Roche Limited’s Drug Safety Department is located at 2455 Meadowpine Boulevard, Mississauga, Ontario, L5N 6L7 and may be reached, toll free, at 1.888.762.4388; by fax at 1.905.542.5864; and by email to: email@example.com. Roche’s Drug Information Department may be reached toll-free at Hoffmann-La Roche Limited 1.888.762.4388, Monday to Friday, between 8:30 a.m. and 4:30 p.m., Eastern Standard Time.