FDA issues alert on potential dangers of unproven treatment for multiple sclerosis

The U.S. Food and Drug AdministrationThe U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called "liberation therapy" or the "liberation procedure" to treat chronic cerebrospinal venous insufficiency (CCSVI).

Some researchers believe that CCSVI, which is characterized by a narrowing (stenosis) of veins in the neck and chest, may cause multiple sclerosis (MS) or may contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord. However, studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established.

"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," said William Maisel, M.D., M.P.H., chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health. "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."

The experimental procedure uses balloon angioplasty devices or stents to widen narrowed veins in the chest and neck. However, the FDA has learned of death, stroke, detachment and migration of the stents, damage to the treated vein, blood clots, cranial nerve damage and abdominal bleeding associated with the experimental procedure. Balloon angioplasty devices and stents have not been approved by the FDA for use in treating CCSVI.

MS is a progressive, immune-mediated disorder of the brain and spinal cord. In MS, the lining around nerve fibers, and often the nerve fibers themselves, in the brain and spinal cord are injured, resulting in significant and disabling neurological symptoms. The underlying cause of MS is not known.

Complications following CCSVI treatment can be reported through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The FDA also is notifying physicians and clinical investigators who are planning or conducting clinical trials using medical devices to treat CCSVI that they must comply with FDA regulations for investigational devices. Any procedures conducted are considered significant risk clinical studies and require FDA approval, called an investigational device exemption.

In February 2012, the FDA sent a warning letter to a sponsor/investigator who was conducting a clinical study of CCSVI treatment without the necessary approval. The sponsor/investigator voluntarily closed the study.

The FDA will continue to monitor reports of adverse events associated with "liberation therapy" or the "liberation procedure" and keep the public informed as new safety information becomes available.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Most Popular Now

Sanofi and GSK sign agreements with the Government…

Sanofi and GSK have signed agreements with the Government of Canada for the supply of up to 72 million doses of an adjuvanted COVID-19 vaccine, beginning in 2021. Thom...

Johnson & Johnson initiates pivotal global Pha…

Johnson & Johnson (NYSE: JNJ) (the Company) announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, J...

Scientists trace severe COVID-19 to faulty genes a…

More than 10 percent of young and healthy people who develop severe COVID-19 have misguided antibodies that attack not the virus, but the immune system itself, new resear...

Johns Hopkins researchers publish COVID-19 'predic…

Using a combination of demographic and clinical data gathered from seven weeks of COVID-19 patient care early in the coronavirus pandemic, Johns Hopkins researchers today...

Researchers uncover early results about an existin…

While scientists race to develop and test a vaccine effective against SARS-CoV-2, the virus that causes COVID-19, recent studies have indicated that countries with widesp...

Web resources bring new insight into COVID-19

Researchers around the world are a step closer to a better understanding of the intricacies of COVID-19 thanks to two new web resources developed by investigators at Bayl...

BioNTech and Pfizer initiate rolling submission to…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a rolling submission to the European Medicines Agency (EMA) for BNT162b2, the lea...

Boost for global response to COVID-19 as economies…

64 higher income economies have joined the COVAX Facility, a global initiative that brings together governments and manufacturers to ensure eventual COVID-19 vaccines rea...

COVID-19 vaccine AZD1222 clinical trial resumed in…

The Phase I/II clinical trial for the COVID-19 vaccine AZD1222 has resumed in Japan after discussion with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). ...

Vir Biotechnology and GSK announce global expansio…

Vir Biotechnology, Inc. (Nasdaq: VIR) and GlaxoSmithKline plc (LSE/NYSE: GSK) announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Eff...

Johnson & Johnson announces European Commissio…

Johnson & Johnson (NYSE: JNJ) (the Company) announced the European Commission (EC), acting on behalf of the European Union (EU) Member States, has approved an Advance Pur...

Adequate levels of vitamin D reduces complications…

Hospitalized COVID-19 patients who were vitamin D sufficient, with a blood level of 25-hydroxyvitamin D of at least 30 ng/mL (a measure of vitamin D status), had a signif...