FDA Warns Of Potential Dangers Of Controversial Multiple Sclerosis Treatment

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There has been much debate about whether 'liberation therapy', an investigational treatment for multiple sclerosis, developed by Italian doctor Paolo Zamboni, really works or not. With reports of death, and serious adverse events like stroke, and abdominal bleeding, the FDA has warned patients and doctors of the potential dangers associated with the use of this controversial treatment.

The liberation therapy involves the use of balloon angioplasty devices or stents to widen narrowed veins in the chest and neck in patients with chronic cerebrospinal venous insufficiency, or CCVI. Chronic cerebrospinal venous insufficiency is characterized by a narrowing of veins in the neck and chest.

Some researchers believe that CCSVI may cause multiple sclerosis or may contribute to the progression of the disease by impairing blood drainage from the brain and upper spinal cord. However, the link between CCVI and multiple sclerosis is yet to be established.

The FDA in a statement said that there is no reliable evidence from controlled clinical trials to prove that this procedure is effective in treating multiple sclerosis, or MS. 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.

Injectables like Teva's Copaxone, Biogen Idec's Avonex and Tysabri, and Merck Serono's Rebif and oral drug Gilenya, developed by Novartis AG, are some of the approved treatments for multiple sclerosis.

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