New Warning Issued For ImClone Systems's Colorectal Drug Erbitux

The government is warning doctors to monitor patients who take Erbitux, a drug for colorectal cancer, for an hour after they receive an injection because of occasional reactions that include trouble breathing, hives or dangerously low blood pressure. The Food and Drug Administration, along with manufacturers ImClone and Bristol-Myers Squibb, on Wednesday announced changes to the drug's warning label that includes the monitoring advice. The warning says about 3 percent of patients who receive an Erbitux injection have a severe reaction. It says fatalities are rare — fewer than one-tenth of 1 percent of patients on the drug — but does not provide specifics. In addition, the label calls for periodic monitoring of a patient taking the drug for several weeks for severe electrolyte depletion. It cites clinical trials. Erbitux is one of a new class of cancer medicines designed to specifically target and disrupt certain molecules that spur tumor growth.

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