(MENAFN) In a significant development, scientists have issued warnings about drugs touted as revolutionary in the treatment of Alzheimer's disease, emphasizing that the associated risks may outweigh the anticipated benefits. The concerns are particularly relevant to two drugs, lecanemab and donanemab, currently under consideration by United Kingdom regulators for approval, with lecanemab already receiving the green light from United States regulators last year.
Manufacturers claim that these drugs have the potential to be game-changers by slowing cognitive decline in Alzheimer's patients through the clearance of amyloid protein in the brain's gray matter. However, an alarming downside has emerged, as these drugs are reportedly causing brain shrinkage in patients. Additionally, up to a third of individuals receiving these medications are experiencing side effects categorized as "amyloid-related imaging abnormalities" (ARIA), a broad term encompassing brain swelling and bleeding.
The severity of these side effects is underscored by the fact that around 1 percent of patients face consequences so severe that they are either fatal or necessitate hospitalization. Recognizing the potential risks, the United States Food and Drug Administration has mandated lecanemab's manufacturer, Esai, to include a "black-box warning" on its label, signaling the possibility of serious adverse events.
Professor Rob Howard from the University College of London Institute of Mental Health expressed concern, likening the brain scans of patients with ARIA to those who have experienced strokes or traumatic brain injuries. Analysis of imaging data further reveals that individuals undergoing treatment with these drugs are losing a significant amount of brain volume, equivalent to slightly more than a teaspoon, according to Professor Howard. Dr. Madhav Thambisetty, a senior clinical investigator at the United States National Institute on Aging, added that patients receiving the highest doses have seen up to three teaspoons of brain volume loss.
As United Kingdom regulators weigh the decision on the approval of these Alzheimer's drugs, the cautionary insights from scientists underscore the critical need for a comprehensive understanding of the potential risks associated with these medications, prompting a reevaluation of the balance between benefits and potential harm in the pursuit of effective Alzheimer's treatments.
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