THURSDAY, May 10 (HealthDay News) -- Doctors and patients need to be aware of the potential risk of injuries and death associated with an experimental treatment for multiple sclerosis called liberation therapy, the U.S. Food and Drug Administration said in an alert issued Thursday.
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Liberation therapy is used to treat chronic cerebrospinal venous insufficiency (CCSVI) -- a narrowing of veins in the neck and chest -- believed by some to cause multiple sclerosis (MS) or worsen the disease. They think it does so by impairing blood drainage from the brain and upper spinal cord.
The controversial procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. But the FDA has not approved this treatment for chronic cerebrospinal venous insufficiency, and the agency said it has learned of deaths, strokes, damage to the treated vein, blood clots, cranial nerve damage, abdominal bleeding, and migration of stents in the body as a result of the treatment.
Also, studies examining a possible link between the two conditions are inconclusive, and the criteria used to diagnose chronic cerebrospinal venous insufficiency have not been adequately established, the FDA said.
"Because there is no reliable evidence from controlled clinical trials that this procedure is effective in treating MS, FDA encourages rigorously conducted, properly targeted research to evaluate the relationship between CCSVI and MS," Dr. William Maisel, chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health, said in an agency news release.
"Patients are encouraged to discuss the potential risks and benefits of this procedure with a neurologist or other physician who is familiar with MS and CCSVI, including the CCSVI procedures and their outcomes," he added.
MS is a progressive autoimmune disease that affects the nervous system. Its underlying cause is unknown.
The FDA also is notifying doctors and clinical investigators who are planning or conducting clinical trials using medical devices to treat chronic cerebrospinal venous insufficiency that they must comply with FDA regulations for investigational devices.
Dr. Fred Lublin, director of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai School of Medicine in New York City, welcomed the alert. "The FDA's action is well-founded and provides an important safeguard for individuals with MS," he said.
"There are safety issues with the procedures associated with CCSVI, as detailed in the FDA alert," Lublin said. He also said the very existence of chronic cerebrospinal venous insufficiency is unclear. And, "whether there is any relationship between CCSVI and MS, as either a cause or consequence, is unproven," he added.
Without scientific studies supporting the treatment of chronic cerebrospinal venous insufficiency in patients with MS, the procedure cannot be recommended, Lublin said.
-- Robert Preidt
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SOURCES: Fred Lublin, M.D., Saunders Family Professor of Neurology and director, Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai School of Medicine, New York City, and co-chief editor, Multiple Sclerosis and Related Diseases; U.S. Food and Drug Administration, news release, May 10, 2012