FDA Safety Letter Regarding PE and Extracorporeal Photopheresis (ECP) Treatment – On February 5, 2018, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals that it is evaluating recent reports of venous thromboembolism (VTE), including pulmonary embolism (PE), in patients treated with autologous immune cell therapy with the CELLEX Photopheresis System by Therakos, Inc. According to the FDA Alert, these events typically occurred during, or shortly after treatment sessions.
The FDA reported that since 2012, it has received seven reports of patients experiencing PE during or soon after treatment (average of 1.2 days). The agency provided the following information regarding the seven reports of PE.
“Two of these reports were associated with the death of the patient, although the link between the PE and death cannot be made with certainty. Of the seven PE events, four occurred in patients known to be undergoing treatment for GVHD, including the two patients who died. In addition to PE, the FDA has received two reports noting the diagnosis of a deep vein thrombosis (DVT) in an extremity of a patient during, or soon after, an ECP session. Both of these occurred in patients undergoing treatment for GVHD. Although allogeneic transplant patients who develop GVHD are known to be at increased risk for VTE, the timing of the events in these reports suggests that ECP therapy may increase that risk.”
The following recommendations to healthcare professionals were included in the FDA Healthcare Letter:
- Alert patients, and clinical staff and technicians involved in ECP procedures, to the signs and symptoms of PE and DVT that can develop during or after a procedure.
- Refer to device labeling regarding considerations for anticoagulation use with this system and use clinical judgment in adjusting an individual patient’s heparin dosage.
- Report VTE events related to ECP procedures that come to your attention.
Pulmonary Embolism and Blood Clot Lawsuit Information
The Weinberg Law Firm is currently assisting those injured by PE and Blood Clots related to medical negligence and drug side effects. If you would like more information, please see Blood Clot Lawsuit or call our firm toll free at 877-934-6274.
