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FDA Warns About Dangers of 'Liberation Therapy' for MS
May 10, 2012 — A controversial treatment for multiple sclerosis (MS) called "liberation therapy" comes with serious risks and unproven benefits, the US Food and Drug Administration (FDA) warned today.
The treatment, also called the "liberation procedure," involves widening narrowed internal jugular or azygos veins with stents or balloon angioplasty in patients with chronic cerebrospinal venous insufficiency (CCSVI). Some researchers think that the impaired blood drainage associated with CCSVI may trigger MS, or else worsen its progression, according to the FDA. Yet "studies exploring a link between MS and CSSVI are inconclusive," the agency stated, adding that "there is no clear diagnostic evidence that CCSVI exists as a distinct clinical entity."
A meta-analysis of these studies published last fall in the Canadian Medical Association Journal reported a strong and statistically significant association between the 2 conditions, although researchers said they could not reach a definite conclusion about the role of CSSVI in MS.
In its announcement today, the FDA said that there is no clear scientific evidence showing that liberation therapy is safe or effective in lessening MS symptoms or improving the quality of life of patients with the disease. Some patients undergoing the procedure have experienced serious and sometimes fatal adverse events such as bleeding in the brain, stroke, migration of stents, venous injury, blood clots in the jugular vein or stents, cranial nerve damage, and abdominal bleeding.
The FDA also said that physicians and clinical investigators who plan to conduct clinical trials to treat CCSVI with vein-widening devices must first obtain an investigational device exemption from the agency because of the significant risks involved. In February, the agency warned a CCSVI investigator in Albany, New York, that he lacked this exemption. The investigator, a vascular surgeon, voluntarily stopped the study, according to the agency.
More information about today's FDA announcement is available on the agency's Web site.
To report adverse events related to CCSVI procedures, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/ ... online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
FDA Warns About Dangers of 'Liberation Therapy' for MS
May 10, 2012 — A controversial treatment for multiple sclerosis (MS) called "liberation therapy" comes with serious risks and unproven benefits, the US Food and Drug Administration (FDA) warned today.
The treatment, also called the "liberation procedure," involves widening narrowed internal jugular or azygos veins with stents or balloon angioplasty in patients with chronic cerebrospinal venous insufficiency (CCSVI). Some researchers think that the impaired blood drainage associated with CCSVI may trigger MS, or else worsen its progression, according to the FDA. Yet "studies exploring a link between MS and CSSVI are inconclusive," the agency stated, adding that "there is no clear diagnostic evidence that CCSVI exists as a distinct clinical entity."
A meta-analysis of these studies published last fall in the Canadian Medical Association Journal reported a strong and statistically significant association between the 2 conditions, although researchers said they could not reach a definite conclusion about the role of CSSVI in MS.
In its announcement today, the FDA said that there is no clear scientific evidence showing that liberation therapy is safe or effective in lessening MS symptoms or improving the quality of life of patients with the disease. Some patients undergoing the procedure have experienced serious and sometimes fatal adverse events such as bleeding in the brain, stroke, migration of stents, venous injury, blood clots in the jugular vein or stents, cranial nerve damage, and abdominal bleeding.
The FDA also said that physicians and clinical investigators who plan to conduct clinical trials to treat CCSVI with vein-widening devices must first obtain an investigational device exemption from the agency because of the significant risks involved. In February, the agency warned a CCSVI investigator in Albany, New York, that he lacked this exemption. The investigator, a vascular surgeon, voluntarily stopped the study, according to the agency.
More information about today's FDA announcement is available on the agency's Web site.
To report adverse events related to CCSVI procedures, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at https://www.accessdata.fda.gov/scripts/ ... online.htm, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.