Erbitux FDA Alerts
The FDA Alert(s) below may be specifically about Erbitux or relate to a group or class of drugs which include Erbitux (cetuximab).
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.
Recent FDA Alert(s) for cetuximab
Sep 14, 2005
Audience: Oncologists and other healthcare professionals[Posted 09/14/2005] ImClone Systems Incorporated, Bristol-Myers Squibb Company and the FDA notified healthcare professionals of changes to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Erbitux, indicated for the treatment of epidermal growth factor receptor (EGFR) expressing metastatic colorectal carcinoma. The WARNINGS and DOSAGE AND ADMINISTRATION sections have been revised to notify healthcare providers about specific recommendations on observation periods following Erbitux infusion. In addition, the PRECAUTIONS and ADVERSE REACTIONS sections have been revised to discuss results seen in Erbitux clinical trials regarding an increased incidence of hypomagnesemia and recommendations for electrolyte monitoring.