Skin Reaction in Children and Adults with Central Nervous System Disease after Intracutaneous Administration of Myelin Preparations derived from Human Brain

Boehme, D; Paal, G; Kersten, W.; Kersten, H.

doi:10.1038/199084a0

Cited by 3 publications

(1 citation statement)

References 8 publications

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“…Prevalence of asthma with ALS has been reported between 25 and 31% [ 19 , 20 ], whereas there has been only one reported case of urticaria and ALS [ 21 ]. Anaphylaxis immediate sensitivity-type reactions in ALS patients have been reported following injections of human myelin and penicillin as well as oral levamisole [ 22 – 24 ].…”

Section: Discussionmentioning

confidence: 99%

Analysis of the US Safety Data for Edaravone (Radicava®) From the Third Year After Launch

et al. 2022

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Background Amyotrophic lateral sclerosis (ALS) is a progressive and fatal neuromuscular disease with no curative therapies. Edaravone (Radicava ® ) (Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan), approved in the United States (US) for ALS in adults in 2017, was shown in a clinical trial to slow the rate of physical functional decline in ALS and is administered intravenously. The aim of this paper is to summarize the observed safety profile from real-world patient use during the first 3 years of edaravone availability in the US. Methods Edaravone usage data were collected, and adverse events (AEs) were identified from a postmarketing safety database from August 8, 2017 through August 7, 2020 (cutoff date). Results As of October 3, 2020, 5207 ALS patients had been treated with edaravone. As of August 7, 2020, the most commonly reported AEs included death (not specified), drug ineffective, disease progression, therapeutic response unexpected, fall, asthenia, fatigue, muscular weakness, gait disturbance, and dyspnea. The most commonly reported serious AEs (SAEs) included death (not specified), pneumonia, disease progression, ALS, fall, dyspnea, respiratory failure, device-related infection, hospitalization, and injection-site infection. There were 687 deaths, with 494 reported as death without specifying the cause. Deaths were most commonly attributed to ALS, disease progression, respiratory failure, or pneumonia. Review for administration-site reactions revealed 95 AEs, including 34 site infections, with 22 SAEs (all non-fatal). Five non-fatal SAEs of anaphylaxis were reported. Conclusion In the postmarketing reporting to date, no new safety signals were identified beyond those already known from the edaravone clinical trial program.

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