FDA Eyeing Reports of Pulmonary Embolism Linked to Therakos CELLEX Photopheresis System

WASHINGTON, D.C. - The Food and Drug Administration says it has received reports of venous thromboembolism (VTE), including pulmonary embolism (PE), in patients who received autologous immune cell therapy with Therakos Inc.'s CELLEX Photopheresis System.

According to a Feb. 5 letter to health care providers, since 2012, the agency has received seven reports of patients experiencing PE during, or soon after, a CELLEX treatment. Two of those reports were associated with the patient's death, although the FDA cautioned that the link between the PE and death is not definite.

Of the seven PE events, four occurred in patients known to …