Page 4 - Brain Bleeding News Today

The fda approved the new drug. they claim only, though, it quote may modestly slow the pace of doing anytive decline early on in the disease. fda is acknowledging it has major risks for patients. the manufacturer says, quote, accelerated approval of the drug was based on phase two data. here is where things get controversial. the fda acknowledges the drug exposes patients to the risk of brain swelling and brain bleeding. in a recent congressional investigation issued a scathing finding when it c...

Disease and try to reduce the amount of cognitive decline. and so it offers this novel therapy. there is a lot of po fence for it. but i think there is still a number of unanswered questions, including about side effects. specifically, there are some side effects that seem to be associated with this drug, brain swelling, brain bleeding. the question is, are we able to identify which patients will be eligible for it and which patients for whom the benefits outweigh the risk. another unanswered qu...

>> reporter: dr. sharon cohen has been studying alzheimers drugs for 30 years and was part of the clinical trials for lecanemab. what she is talking about is amyloid originating abnormality. it can look like this or this. its brain swelling or brain bleeding. know cohen says these types of side effects were mostly mild in the trial. >> we do know that lecanemab has a low rate of causing macro hemorrhage, not necessarily fatal, but a low rate, less than 1%. >> reporter: in the phase three clinica...

Care of themselves and the pathology and the plaques and the tangles have built up and by that time there is not as much we can do. >> reporter: but nothing comes without risks. and the ones that come with this type of drug have raised red flags. >> we have known for many years that with almost all of the drugs in this class there can be a side effect of aria. >> reporter: dr. cohen has been studying alzheimers drugs for 30 years and was part of the clinical trial. what she is talking about is a...

Progression to worsening of his alzheimers disease. >> weve been targeting alzheimers disease at the end stage when people have dementia and can no longer take care of themselves and theplaque and tangles have built up. >> there could be risks and this one draws red flags. >> we have known for many years that almost all of the drugs in this class there could be a side effect of aria. >> dr. sharon cohen has been studying alzheimers drugs for 20 years and was part of the clinical trial. what she ...

Based on clinical trials, more than a thousand adults and in the trial it was found that the drug appeared to reduce cognitive and functional decline by 27%. and that same trial we also saw some serious adverse events. 14% of people experienced adverse events compared with 11.3% who took a placebo. and some of the adverse events were a side effect and a small percentage of the group, including brain swelling and brain bleeding and some researchers have noticed that some people are at a certain g...

But we have to be cautious about it. >> while the data is encouraging, there were some safety concerns. brain swelling and brain bleeding. those are certainly things the fda will evaluate if the drug comes up for approval. number eight. mental health. in a cnn kff poll, 90% of adults believe there is a mental health crisis in the united states and another survey found nearly one in four adults age 18 to 44 were treated for mental health in 2021. reflecting an increased anxiety and depression dur...

Or slowing of that clinical cognitive decline. they also looked at plaque in the brain. not surprisingly, the group that got the drug, the plaque decreased. >> still decline in cognitive ability but slower decline for people on the drug. >> thats right. >> the risks and side effects. important. >> always important to talk about this. we are always weighing and risks and benefits. there were some adverse side effects we should point out. the most common was infusion reactions. but they also saw i...

Were some adverse side effects associated with the drug lecanemab that we should point out. the most to come was infusion reactions. but they also saw on increase in brain edema, or swelling in the lecanemab group as well as the bone group, as well as a brain hemorrhage or bleeding. most of these are mild and asymptomatic and got better, however, brain bleeding and swelling can cause headache, confusion, visual changes, hospitalization, and have a longer term impact. when you compare the overall...

So the two big questions are, well, thats good, no question, but is that enough to make a difference? will they be able to function better? will their families notice a difference? the second question is, what about the side effects? thats a serious question for this drugs. 17% of the people who took the drug on the study, 17% had brain bleeding. another 12% had brain swelling. now, to be clear, some of the folks who took the placebo had those two things, too, but nearly at rates that high. the ...