In the June 2013 volume of Oncology Letters journal, a study was published that found cancer patients treated with cetuximab (brand name Erbitux) were at increased risk for hypomagnesemia (low levels of magnesium in the blood). Researchers conducted a meta-analysis to determine the strength of association between cetuximab and this adverse event. Investigators found that 3.9% of cancer patients treated with cetuximab experienced hypomagnesemia, and that these patients were at a significantly increased risk for development of this side effect compared to controls.
Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor used to treat head, neck, and colorectal cancers. Hypomagnesemia can result in muscle cramps, weakness, cardiac arrhythmia, high blood pressure, disorientation, and confusion. Proper levels of magnesium are required in order for the body to maintain internal regulation.
Researchers sought to determine the extent of the association between cetuximab and hypomagnesemia. The final analysis included 7,045 patients with advanced forms of cancer, treated with or without cetuximab. The relative risk of high grade hypomagnesemia in patients treated with cetuximab was 8.6 compared to control groups. Patients with non-small cell lung cancer exhibited the highest incidence of hypomagnesemia, with 9% of patients experiencing this side effect. Researchers concluded that cetuximab was related with a significant risk of hypomagnesemia in advanced cancer patients.
Erbitux (cetuximab) is an epidermal growth factor receptor (EGFR) inhibitor indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy. It is also indicated for KRAS mutation-negative (wild-type), EGFR-expressing, metastatic colorectal cancer as determined by FDA-approved tests. It is a recombinant, human/mouse chimeric monoclonal antibody. Erbitux was first approved by the FDA on February 12, 2004 and is co-marketed by Bristol-Myers Squibb and Eli Lilly and Company.
Using FAERS data (from 11/01/1997 to 08/27/2012), aggregated and standardized by the AdverseEvent RxFilter process, we identified 11,879 serious adverse events which listed Erbitux as a suspect drug. Of these reports, 9,206 listed Erbitux as the primary suspect. We identified 239 case reports which listed Erbitux as the primary suspect drug associated with hypomagnesemia.