According to the AP, the agency will slap its 'most serious warning label' on all Regranex boxes.
The findings come from a long-term analysis of records from health care providers comparing 1,600 patients who took Regranex with 2,800 patients who did not, according to the FDA.The new label, which is outlined in a black box, advises doctors to use caution when prescribing the drug to patients with malignancies.
Regranex is a man-made version of a substance produced by the human body that helps heal ulcers. Because the drug causes cells to divide more rapidly, the FDA said Johnson & Johnson closely monitored patients for reports of cancer, which spreads through uncontrolled cell division.
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