June 26, 2014

FDA issues safety communication about CCSVI and MS

The U.S. Food and Drug Administration (FDA) issued a safety communication about the potential risk of procedures and devices used to treat CCSVI (chronic cerebrospinal venous insufficiency) in people living with MS. The FDA reviews these risks and supports further research to understand more about CCSVI and its relationship to MS that will aid people living with MS in making informed treatment decisions.

The intent of the communication developed by the FDA is to highlight risks of the procedure to individuals with MS, physicians and investigators conducting clinical trials related to CCSVI. The communication contains the following key points for people with MS:

  • there is no clear evidence that demonstrates a definite link between MS and CCSVI;
  • the safety and effectiveness of using balloon angioplasty with or without stents in the internal jugular or azygos veins has not been established for any medical condition; nor has the FDA approved the use of these devices in these veins;
  • serious complications can occur as a result of CCSVI treatment procedures;
  • before considering treatment, the FDA recommends that people discuss potential risks and benefits with a neurologist who is familiar with MS and CCSVI;
  • before having any CCSVI procedure, the FDA recommends that people discuss with their health care provider the signs and symptoms of complications of these procedures;
  • people who undergo procedures to diagnose or treat CCSVI are recommended to continue following the MS treatment plan outlined by their health care providers;
  • anyone considering participating in a clinical trial for CCSVI is encouraged to learn as much as possible about the trial and ask questions of the health care team conducting the trial; and
  • anyone undergoing treatment for CCSVI who experiences a complication is encouraged to file a report with the FDA through the MedWatch, the FDA’s safety information and adverse event reporting program (http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm)

Adverse events have been reported to the FDA following the CCSVI procedure which included two deaths, incidents of stroke, blood clots, cranial nerve damage and abdominal bleeding. According to the safety communication, frequency of these complications is unknown. It also mentions that the FDA will continue to monitor for adverse events related to medical devices commonly used in CCSVI treatment, and keep the public informed as new information becomes available.

More Research Encouraged
The FDA communication encourages research to evaluate the relationship between CCSVI and MS and to characterize the safety and effectiveness of treatment procedures.

Although some individuals who have MS have undergone surgical procedures for CCSVI, there has not yet been a controlled trial to determine its effectiveness in treating the symptoms or course of the disease. The Canadian Institutes of Health Research (CIHR) announced in April 2012 that a research team had been chosen to conduct a phase I/II clinical trial to determine the safety of venous angioplasty and obtain evidence on patient outcomes in people with MS. The location of the study has not yet been announced. The clinical trial is a joint initiative between the CIHR and the MS Society of Canada.

In collaboration with the MS Society of Canada, the National MS Society has been at the forefront of researching the potential links between CCSVI and MS and in July 2010 launched seven research studies with a commitment of more than $2.4 million. The research teams have recruited a broad spectrum of people with MS as well as individuals with other disease types and healthy controls to build an understanding of who may be affected by CCSVI. In addition, they have been refining CCSVI imaging methods for accuracy and consistency to reliably validate the occurrence of CCSVI and understand its implications in the MS disease process. After the research projects are completed, the studies will be analyzed and submitted for publication in one or more scientific journals. At this point it isn’t clear when full data and results will be available to the public. In the meantime, several of the investigators have been sharing their results with other scientists at medical meetings. Results from the seven projects as well as other CCSVI studies will help guide the Society’s planning for future investments in this area of research.

For more information about CCSVI and MS in Canada please visit www.ccsvi.ca.

Canadians who undergo procedures to diagnose or treat CCSVI are recommended to continue following the MS treatment plan outlined by their health care providers. If you are concerned that you might have complications resulting from a CCSVI-related procedure, be sure to seek immediate medical help.

Source: U.S. Food and Drug Administration