June 17, 2022: In 2018 FDA was concerned about “the numbers of reports of death and other serious adverse events” regarding this drug, which already carries a black box warning that there is “increased mortality in elderly patients with dementia-related psychosis.” To outweigh such serious safety risks, the benefits of this drug would need to be substantial. However, there is no such evidence.
Read More »Tag: alzheimer’s disease
Will the FDA change how it vets drugs following the Alzheimer’s debacle?
Nature, May 13, 2022: Nearly a year after the FDA approved a controversial drug to treat Alzheimer’s disease, Congress is attempting to amend the accelerated process that led to its approval and also the approval of many cancer drugs that have not been proven to work.
Read More »Aduhelm for the Treatment of Mild Alzheimer’s disease: Controversies and Policies
This article will provide an overview of the controversial drug Aduhelm (generic name aducanumab) that was approved by the Food and Drug Administration (FDA) as a treatment for Alzheimer’s disease for patients with mild cognitive impairment due to Alzheimer’s.
Read More »What You Need to Know About Alzheimer’s Disease and Other Dementias
Alzheimer’s Disease is one of the leading causes of death for Americans ages 65 and older. It is the most common cause of dementia (as much as 60-80% of dementia cases are caused by Alzheimer’s Disease), and 11% of Americans ages 65 and older are estimated to have dementia caused by Alzheimer’s Disease
Read More »High Praise, Condemnation for CMS Aduhelm Coverage Plan
Medscape Medical News, February 16, 2022: Medicare has received a key endorsement and considerable support for its plan to restrict payment for the controversial Alzheimer’s disease drug aducanumab (Aduhelm) — but also drew pleas from other groups for more generous reimbursement of the drug.
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