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Warnings for CCSVI

Monday May 14 2012 02:40 PM

The chief regulatory body in the USA warns people with MS to be cautious about undergoing CCSVI treatment

 

The Food and Drugs Administration (FDA) who regulate all medical products, devices and procedures in the USA, today brought out a Safety Communication in relation to chronic cerebrospinal venous insufficiency (CCSVI). The administration is alerting people of the risks involved in the treatment and the fact that evidence is not sufficient yet to make it a valid treatment for MS.
 

The FDA point out that conflicting pieces of research exist that draw links between MS and the narrowing of veins. There are also no established criteria to diagnose CCSVI.

 

The FDA is informing people with MS of some of the risks of the procedure which include:

 

     

  • Narrowing of the veins often happens in people without MS so they are unlikely to be the cause of symptoms

  • Balloon angioplasty or stents in the veins is not a proven treatment for any condition

  • A range of side effects including blood cloths, migration of the stent, paralysis and death 

 

The FDA has issued some advice to people with MS who are considering the treatment. This includes:

     

  • Be aware that no conclusive evidence exists as to the benefit of the procedure

  • Consult with your neurologist before deciding on a treatment

  • Find out as much as you can about the organisation that is conducing the clinical trail you wish to go on

  • Follow you regular treatment plan

  • Report any adverse reactions to the regulator

 

Read the FDA’s full statement here.

Author: MS Ireland/FDA

Tags: research, ccsvi

Comments

Michele Findlay

Friday August 17 2012 13:30

FDA have no remit to pass comment on a surgical procedure. They are a foods and drugs agency and they have approved Tysabri which has killed many more people than any venoplasty for CCSVI and is also proving less effective.

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