The Food and Drug Administration (FDA) has updated safety labeling for Johnson & Johnson's (NYSE:JNJ) Carvykti after receiving reports of immune effector cell-associated enterocolitis (IEC-EC)—a rare but serious complication seen in both clinical trials and postmarketing data.
The condition has been linked to fatal cases of gut perforation and sepsis, with patients experiencing severe diarrhea, abdominal pain, and weight loss that often required total parenteral nutrition and immunosuppressive therapy.
