FDA Says New MS Therapy Risky
Federal health regulators are once again warning patients and doctors that an experimental treatment for multiple sclerosis (MS) may be linked to life-threatening injuries including stroke and paralysis.
Reuters reports that despite the warning some doctors continue to treat chronic cerebrospinal venous insufficiency (CCSVI) in MS patients with an experimental technique in which angioplasty balloons or stents are employed to open up narrowed veins in the neck and chest to help blood drain from the brain.
The Food and Drug Administration (FDA) issued an official warning earlier this year regarding the use of the technique in MS patients. The FDA says it is unclear that MS patients suffer from CCSVI and the new treatment hasn’t been deemed safe for them, writes Reuters. But some doctors are still using it on new patients saying that it helps reduce symptoms in those suffering from MS, Parkinson's disease, and other neurological conditions.
The FDA has received one report of death and another of paralysis in patients who underwent the treatment for CCSVI. However, the agency is limited in its ability to restrict the off-label use of approved medical devices or drugs by doctors.
The FDA does say that doctors must inform MS patients about the risks involved in an off-label therapy before they undergo the procedure, according to Reuters.
If you or a loved one has experienced an injury due to a defective medical device, contact Sokolove Law today for a free legal consultation and to find out if a product liability lawyer may be able to help you.