ADR that result in revision of patient information
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| The United Kingdom: Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that the paediatric indication for chloral hydrate (for children aged 2 years and older) and cloral (previously chloral) betaine (children aged 12 years and older) has been restricted to short-term treatment (maximum 2 weeks) of severe insomnia only when the child or adolescent has a suspected or definite neurodevelopmental disorder and when the insomnia is interfering with normal daily life. Chloral hydrate and cloral betaine should only be used when other therapies (behavioural and pharmacological) have failed.
In the United Kingdom (UK), Chloral hydrate (Welldorm Elixir) and its prodrug cloral betaine (Welldorm) are older drugs that retain some limited clinical usage. In 2009, following a national review of safety and efficacy, the authorisation for these medicines was restricted to severe insomnia that is interfering with normal daily life and where other therapies have failed, as an adjunct to non-pharmacological therapies. Chloral hydrate is licensed for use in adults and in children aged 2 years and older. Cloral betaine tablets are licensed for use in adults and adolescents aged 12 years and older.
The MHRA has conducted a further review of safety and efficacy data for these medicines and sought independent expert advice from the Commission on Human Medicines (CHM), its Neurology, Pain and Psychiatry and Paediatric Medicines Expert Advisory Groups, as well as experts in paediatric sleep disorders.
No new safety concerns were identified. However, in view of known carcinogenicity data in animals and because of concerns regarding the lack of long-term studies, a risk in humans in long-term use cannot be excluded on the basis of available data. As such, the CHM recommended that the paediatric indication of all chloral hydrate and cloral betaine products should be restricted to use only in children and adolescents with suspected or definite neurodevelopmental disorders, where the benefits of short-term use outweigh any potential risk. These changes reflect current clinical practice.
In UK, the product information is being amended to further clarify that use of chloral hydrate and cloral betaine is not recommended in children and adolescents except in these very restricted circumstances and should only be under the supervision of a specialist
Prolonged use of chloral hydrate and cloral betaine has been associated with tolerance and the risks of dependence and abuse. The maximum treatment period for these medicines in all patients has now been defined as 2 weeks in the product information.
Repeated courses are not recommended and can only be administered following medical specialist re-assessment. Following prolonged treatment, the dose should be slowly tapered before discontinuation to avoid delirium.
For the off-label use, the MHRA are aware that chloral hydrate is used for sedation in children, for example in intensive care units and before diagnostic procedures. The immature metabolism of infants and neonates results in a prolonged half-life of metabolites in these groups, with an increased risk of undesirable effects. This factor and the lack of long-term studies to demonstrate safety should be taken into account when considering prescribing in this population outside the currently licensed indication.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-safety-update/chloral-hydrate-cloral-betaine-welldorm-restriction-of-paediatric-indication
In Hong Kong, there are 3 registered pharmaceutical products containing chloral hydrate, including Syrup of Chloral 1g/5mL (HK-21514), PMS-Chloral Hydrate Syrup 100mg/mL (HK-62019) and Migaphen Cap (HK-44850). All these products are prescription only medicines. There is no registered pharmaceutical product in Hong Kong for cloral betaine.
So far, the Department of Health (DH) has received one case of adverse drug reaction (ADR) with chloral hydrate, which was not related to the carcinogenic risks and long-term use mentioned in the above MHRA announcement; and no ADR report has been received for cloral betaine. In light of the MHRA announcement, letters to inform local healthcare professionals will be issued, and the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board.
Ends/ Thursday, October 7, 2021
Issued at HKT 15:15
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