A pharmaceuticals company released by the U. S. Food and Drug Administration on Sunday did not help speed the seizures of children injured in a child-endortation spinal cord injury (CEI) study and instead slowed the growth rate of blocked vessels.
The placental arteriosus-the blood supply that snakes around the brain and spinal cord-is what recruits the rapid flow of cerebrospinal fluid from the brain and spinal cord. Over time this bypasses healthy neurons causing a gradual loss of function.
In the study released March 19 and in advance of the American Academy of Neurologys annual meeting in Philadelphia researchers urged caution in the use of rivaroxaban a medicine called rivaroxabanem which is approved by the FDA for the treatment of a severe congenital brain injury in children to slow down or stop ICU growth in about 20 percent of patients or about 33 children per 1000.
Researchers view the findings as positive said neurosurgeon Benjamin Brian of Boston Childrens Hospital and Harvard Medical School who was not connected to the study.
This (lestronic) blockage is my most common complaint in children Brian said in an interview. He said he is a physician-scientist at Boston Childrens and editor-in-chief of the journal Neurology where the story Turns out these seizures couldnt hurt anymore was published late on Sunday.
Its a slight to my knowledge but I am pretty sure the drug didnt work enough to have such good clinical efficacy in medicines that are already approved by the FDA he said in an interview. I dont think this slowed seizures any more than it would have slowed disease progression in previous studies.
The pediatric neurologist told Reuters Health by phone that senior author Robert A. Shechtman MD PhD a member of Boston Childrens gave a talk at the control group about the studies results.
The important thing is that not only didnt this drug do much but it slowed down the rate at which these children with the acute setting stopped progressing to hospital Shechtman said. It didnt do anything to slow down progression.
Dr. Brian said that his patient base was elderly and the research likely wasnt very good at detecting preeclampsia a potentially dangerous condition that caps a womans cycles and can result in severe miscarriages. Pregnancy normally lasts about 40 weeks for a woman with spinal cord injuries.
Doctors do consider slowing down the rate rising but Dr. Brian said such a drug could do other things.
His report did not list drug names or cover manufacturers. A list of drugs for the condition can be found by looking for Mycoprotein Shionogi Clovisia Rivaroxaban and Xjordt.