<scp>ADHD</scp> medications and cardiovascular adverse events in children and adolescents: cross‐national comparison of risk communication in drug labeling

Sieluk, Jan; Palasik, Brittany N.; dosReis, Susan; Doshi, Peter

doi:10.1002/pds.4164

Cited by 6 publications

(2 citation statements)

References 68 publications

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“…The findings of long-term observations suggest that children with ADHD who were treated with psychostimulants into adulthood may present with a decrease in height as adults without any ongoing improvement in symptomatology [18] . Adverse effects of ADHD medications may also include serious cardiovascular events [19][20][21] . Possible risks of longterm administration of ADHD medication in adults have not been sufficiently explored [5] .…”

Section: Food Science and Human Wellnessmentioning

confidence: 99%

Food intolerance and the few-foods (or oligoantigenic) diet in children with attention-deficit hyperactivity disorder

Lange,

Reissmann,

Nakamura

et al. 2024

Food Science and Human Wellness

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The hypothesis that some children with attention-deficit hyperactivity disorder (ADHD) may show sensitivity or allergic reactions to various food items has led to the development of the the few-foods (or oligoantigenic) diet. The rationale of the diet is to eliminate certain foods from the diet in order to exclude potential allergens contained either naturally in food or in artificial ingredients with allergenic properties. The oligoantigenic diet attempts to identify individual foods to which a person might be sensitive. First, ADHD symptoms are monitored while multiple foods are excluded from the diet. Subsequently, if symptoms remit, foods are re-introduced, while observing the individual for the return of symptoms. An advantage of the oligoantigenic diet is that it can be tailored to the individual. A growing body of evidence suggests that behavioral symptoms of subgroups of children with ADHD may benefit from the elimination of certain foods. The effect sizes of an oligoantigenic diet regarding improvement of ADHD symptoms have been found to be medium to large. Available evidence suggests that the investigation of the role of food hypersensitivities in ADHD is a promising avenue worthy of further exploration. Further large-scale, randomized controlled studies including assessment of long-term outcome are therefore warranted.

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Section: Food Science and Human Wellnessmentioning

confidence: 99%

Food intolerance and the few-foods (or oligoantigenic) diet in children with attention-deficit hyperactivity disorder

Lange,

Reissmann,

Nakamura

et al. 2024

Food Science and Human Wellness

View full text Add to dashboard Cite

show abstract

“…International inconsistencies in drug labeling could cause a risk to patients in countries where accurate or up-to-date information is not available; however, studies which have discussed international concordance of the safety information in drug labeling are limited to a comparison in the count of words in the document [ 3 , 4 ] or a comparison focusing on a specific type of drugs or adverse events [ 5 – 8 ]. In a comparison of drug labeling between Denmark and the US, the low consistency of information related to adverse drug reactions was reported [ 9 ].…”

Section: Introductionmentioning

confidence: 99%

A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United States

Hoshino

Narukawa

2022

Ther Innov Regul Sci

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Purpose Scientific information in the drug labeling is expected to be the most up-to-date and consistent information across countries where medicine is approved. The objective of the present study is to investigate the consistency of safety-related information on product labeling for novel therapeutics concurrently approved in Japan and the US. Methods Safety information at the time of initial approval of new drugs approved concurrently both in Japan and the US in the recent 7 years were identified and reviewed for concordance. Factors associated with the discordance were also investigated. Results Despite the similar medical practices, population health, and regulation in Japan and the US, the level of concordance of safety information found in the drug labeling of 45 new active substances was low (20.4%). The development strategy of the drugs and having the same MAH were significantly associated with the concordance rate. The mean concordance rate among the 9 drugs with Black Box Warning in both countries was also low (32.9%). Conclusions We found a low level of concordance between Japan and the US even when related to clinically important information raised by Black Box Warnings. The low concordance rate highlighted the need for a greater transparency in decision-making processes about the safety information in a drug labeling by both industry and regulators to take appropriate countermeasures against the discordance.

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Cardiovascular Considerations for Stimulant Class Medications

Hammerness

Berger

Angelini

et al. 2022

Child and Adolescent Psychiatric Clinics of North America

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ADHD medications and cardiovascular adverse events in children and adolescents: cross‐national comparison of risk communication in drug labeling

Abstract: Product labeling provides healthcare professionals and consumers with inconsistent messages regarding the potential causal relationship between stimulant use and specific cardiovascular risks in children and adolescents. Copyright © 2017 John Wiley & Sons, Ltd.

Cited by 6 publications

References 68 publications

Food intolerance and the few-foods (or oligoantigenic) diet in children with attention-deficit hyperactivity disorder

Food intolerance and the few-foods (or oligoantigenic) diet in children with attention-deficit hyperactivity disorder

A Comparison of Safety Information in Drug Labeling at the Initial Approval of New Drugs Approved Both in Japan and the United States

Cardiovascular Considerations for Stimulant Class Medications

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