Methylphenidate off-label use and safety

Trenque, Thierry; Herlem, Emmanuelle; Taam, Malak Abou; Dramé, Moustapha

doi:10.1186/2193-1801-3-286

Cited by 24 publications

(17 citation statements)

References 59 publications

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“…Psychostimulants, including methylphenidate (MPH) and amphetamine-based treatments, are the most commonly prescribed pharmacological treatments for adults and children with ADHD 12–14. Despite being one of the mainstay treatments for ADHD, MPH use remains off-label for adults in some countries 15,16…”

Section: Introductionmentioning

confidence: 99%

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

Huß¹,

Duhan²,

Gandhi³

et al. 2017

NDT

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Attention-deficit/hyperactivity disorder (ADHD) is a chronic psychiatric disorder characterized by hyperactivity and/or inattention and is often associated with a substantial impact on psychosocial functioning. Methylphenidate (MPH), a central nervous system stimulant, is commonly used for pharmacological treatment of adults and children with ADHD. Current practice guidelines recommend optimizing MPH dosage to individual patient needs; however, the clinical benefits of individual dose optimization compared with fixed-dose regimens remain unclear. Here we review the available literature on MPH dose optimization from clinical trials and real-world experience on ADHD management. In addition, we report safety and efficacy data from the largest MPH modified-release long-acting Phase III clinical trial conducted to examine benefits of dose optimization in adults with ADHD. Overall, MPH is an effective ADHD treatment with a good safety profile; data suggest that dose optimization may enhance the safety and efficacy of treatment. Further research is required to establish the extent to which short-term clinical benefits of MPH dose optimization translate into improved long-term outcomes for patients with ADHD.

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Section: Introductionmentioning

confidence: 99%

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

Huß¹,

Duhan²,

Gandhi³

et al. 2017

NDT

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“…In addition, prescribing of methylphenidate to adults was not approved until 2010. It is, however, known that off-label prescribing to adults took place before the extension of the approval, 32 thus explaining why many adults are found among the users in this study and even among those who had previous use before the study period. Future research should investigate whether duration of methylphenidate use is a risk factor for overuse.…”

Section: Discussionmentioning

confidence: 79%

“…31 Off-label use has also been reported for depression and Parkinson’s disease. 32 In Sweden, only physicians with a specialization in psychiatry may prescribe methylphenidate. 29 Methylphenidate is included in the Swedish pharmaceutical reimbursement scheme, which means that the users only pay a limited proportion of the cost.…”

Section: Methodsmentioning

confidence: 99%

Overuse of methylphenidate: an analysis of Swedish pharmacy dispensing data

Bjerkeli¹,

Vicente²,

Mulinari³

et al. 2018

CLEP

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PurposeTo identify overuse of methylphenidate and to investigate patterns of overuse in relation to sociodemographic and clinical characteristics.Patients and methodsSwedish national, pharmacy dispensing data were analyzed for all 56,922 individuals aged 6–79 years, who filled a methylphenidate prescription between 2010 and 2011. Overuse was defined as having above 150% days covered by the dispensed amount during 365 days from the first prescription fill, assuming use at the maximum recommended daily dose.ResultsIn total, 4,304 individuals (7.6% of the methylphenidate users) were categorized as overusers. The risk of overuse increased with age (OR for 46–65 years vs 6–12 years 17.5, 95% CI 14.3–21.3), and was higher in men (OR 1.4, 95% CI 1.3–1.5) and individuals with low income (OR 1.1, 95% CI 1.0–1.2), as well as in individuals with an attention deficit hyperactivity disorder (ADHD) diagnosis (OR 1.4, 95% CI 1.3–1.6), health care visits (OR 1.3, 95% CI 1.2–1.4), previous ADHD medication use (OR 2.6, 95% CI 2.4–2.8), and previous diagnosis of mental and behavioral disorders due to psychoactive substance use (OR 2.1 95% CI 2.0–2.3).ConclusionAmong individuals using methylphenidate in Sweden, 7.6% receive amounts that are larger than what they should have a medical need for, assuming that they were using the maximum recommended daily dose 365 days per year. Notably, the prevalence of overuse was associated with previous diagnosis of alcohol and drug misuse. The prevalence was also positively associated with higher age and previous use of ADHD medication. These findings may point toward a link between exposure time and overuse. However, future studies with long-term data are needed to investigate this.

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“…In France, 43% of reported methylphenidate adverse drug reactions are attributable to off-label prescribing (children 30%; adults 88%). 4 Modafinil is associated with psychiatric disorders, cardiovascular symptoms, and serious skin and multiorgan hypersensitivity reactions, and so on; 49% of adverse events relate to off-label prescriptions. 5 In 2011, the European Medicines Agency concluded that the benefits of modafinil could only be considered to outweigh the risks when treating narcolepsy; and recommended that other previous indications (obstructive sleep apnoea, shift-work sleep disorder and idiopathic hypersomnia) be removed from the product information.…”

Section: Adverse Side Effectsmentioning

confidence: 99%

Smart drugs: implications for general practice

Nicholson¹,

Wilson²

2017

Br J Gen Pract

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The familiar landscape of substance misuse in the UK is changing. Recently a briefing in the BJGP highlighted two newer misuse scenarios: legal highs and 'chemsex'. 1 Another new misuse scenario generally escapes the attention of health professionals and others because it does not fit our concept of the term 'recreational drugs', since motivation for use is to enhance performance in exams or at work. However, so-called 'smart drugs' are prescription-only medicines; some being class B drugs. After becoming aware of this emerging issue the BMA Occupational Medicine Committee published a report. 2 This editorial aims to distil the evidence most relevant for primary care specialists. PRESCRIBED USE OF PHARMACOLOGICAL COGNITIVE ENHANCERS Pharmacological cognitive enhancers are licensed for use in three disorders: attention deficit hyperactivity disorder (ADHD), dementia, and narcolepsy. There is no evidence of misuse of drugs used to treat patients with dementia, such as, acetylcholinesterase inhibitors (donepezil, galantamine and rivastigmine) and memantine hydrochloride. Those misused are modafinil, licensed to treat narcolepsyrelated excessive daytime sleepiness; and the class B drug methylphenidate licensed to treat patients with ADHD. The class B drugs dexamfetamine and mixed amfetamine salts (Adderall ®), used as second-line treatment for ADHD and narcolepsy are also misused as smart drugs. Modafinil 3 and methylyphenidate 4 are prescribed off-label, for example for refractory depression, narcolepsy, and Parkinson's disease, and modafinil additionally for multiple sclerosis.

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Methylphenidate off-label use and safety

Cited by 24 publications

References 59 publications

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

Methylphenidate dose optimization for ADHD treatment: review of safety, efficacy, and clinical necessity

Overuse of methylphenidate: an analysis of Swedish pharmacy dispensing data

Smart drugs: implications for general practice

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