Labeling Changes for Aduhelm Detail Risks of ARIA Brain Bleeds

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Title: Labeling Changes for Aduhelm Detail Risks of ARIA Brain Bleeds


Recent changes in the labeling of the Alzheimer’s disease drug Aduhelm (aducanumab) have highlighted the risks associated with Amyloid-Related Imaging Abnormalities (ARIA). ARIA refers to brain abnormalities that can result in brain bleeds. In this blog post, we will discuss the key points regarding the labeling changes for Aduhelm, specifically addressing the risks of ARIA-related brain bleeds.

Key Points

  1. Aduhelm and its Purpose: Aduhelm is a medication developed to target beta-amyloid plaques that accumulate in the brains of Alzheimer’s disease patients. The presence of beta-amyloid plaques is a characteristic feature of the disease. Aduhelm was approved by the U.S. Food and Drug Administration (FDA) in June 2021, marking a significant milestone in Alzheimer’s treatment.
  2. Understanding Amyloid-Related Imaging Abnormalities (ARIA): ARIA is a term used to describe brain abnormalities that can occur as a result of Aduhelm treatment. ARIA is categorized into two types: ARIA-E (edema) and ARIA-H (hemorrhage). ARIA-E involves the accumulation of fluid in the brain, while ARIA-H refers to small bleeding events.
  3. Labeling Changes and Updated Warnings: The FDA required label updates for Aduhelm that specifically address the risks of ARIA-related brain bleeds. The updated labeling explicitly alerts healthcare providers and patients to the possibility of brain bleeds when using Aduhelm. This revised information emphasizes the importance of regular monitoring and prompt reporting of any concerning symptoms.
  4. Risk-Benefit Considerations: The labeling changes for Aduhelm underscore the need for a careful analysis of the risks and benefits associated with the medication. While Aduhelm may offer potential benefits in slowing cognitive decline, patients and healthcare providers must weigh these benefits against the potential risks of ARIA-related brain bleeds. An informed discussion should take place to ensure patients are aware of the potential complications.
  5. Monitoring for ARIA Symptoms: Healthcare providers are advised to closely monitor patients receiving Aduhelm for signs and symptoms of ARIA. These may include headaches, confusion, seizures, or other neurological deficits. Regular brain imaging, such as magnetic resonance imaging (MRI), may be necessary to detect any abnormalities. Patients and caregivers should promptly report any concerning symptoms to their healthcare providers.
  6. Providing Informed Consent: In light of the risks associated with ARIA-related brain bleeds, healthcare providers should ensure that patients and their caregivers are fully informed when making treatment decisions. This involves discussing both the potential benefits and risks associated with Aduhelm, as well as alternative treatment options.
  7. Ongoing Research and Further Evaluation: Post-marketing observational studies have been mandated by the FDA to evaluate the long-term safety and effectiveness of Aduhelm. These studies will provide additional data to better assess the risks and benefits of the medication, including the incidence of ARIA-related brain bleeds.


The labeling changes for Aduhelm regarding the risks of ARIA-related brain bleeds underscore the importance of a comprehensive risk-benefit assessment. Healthcare providers must be vigilant in monitoring patients for signs of ARIA, while also ensuring open communication and informed consent. Ongoing research and post-marketing studies will provide additional insights into the safety and effectiveness of Aduhelm and its impact on patients with Alzheimer’s disease. Ultimately, individualized treatment decisions should consider the unique needs and preferences of each patient, weighing the potential benefits of Aduhelm against the risks of ARIA-related brain bleeds.