Other safety alerts
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| Singapore: New recommendations on the use of domperidone |
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The Health Sciences Authority (HSA) has recently completed a re-assessment to determine if additional measures are necessary to further mitigate the cardiovascular risk associated with the use of domperidone. This follows an earlier assessment in 2012, which resulted in the strengthening of the package inserts of domperidone to include warnings of increased risk of ventricular arrhythmia (VA) and sudden cardiac death (SCD), especially in patients older than 60 years old or those taking oral doses of more than 30 mg daily. Domperidone is registered in Singapore for the treatment of dyspepsia, as well as nausea and vomiting due to various conditions.
HSA has reassessed its risk-benefit following a review of five epidemiology studies, which suggested an association with increased risk of VA and SCD. It was concluded that the benefit-risk profile of domperidone remains favourable when used appropriately for the above indications. Additional measures were recommended to mitigate the risk of cardiotoxicity, which included new recommendations on the dosing regimen, treatment duration and the relevant safety information including contraindications, and update of local package inserts:
． Domperidone is contraindicated in patients with existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac disease and when co-administrated with QT-prolonging medicines or potent CYP3A4 inhibitors.
． An increased risk of cardiotoxicity was observed in patients older than 60 years.
． Domperidone should be used at the lowest effective dose for the shortest possible duration.
． In adults and children aged ≥ 12 years old weighing ≥ 35 kg, the recommended maximum oral daily dose is 30 mg, given in doses of 10 mg up to three times daily. Taking into account the pharmacokinetic studies and bioavailability of rectal suppositories, the recommended rectal suppository dose is 30 mg twice daily.
． In children aged < 12 years old and those aged ≥ 12 years old weighing < 35 kg, the recommended dose is 0.25 mg/kg orally up to three times daily. For rectal administration, these patients may also be given 0.75 mg/kg twice daily as suppositories
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/content/hsa/../new-recommendationsontheuseofdomperidone.html
In Hong Kong, there are 44 registered pharmaceutical products containing domperidone, and are prescription only medicines. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since March 2012, with the latest update posted on 20 October 2016. Letters to inform local healthcare professionals were issued on 8 March 2012 and 10 March 2014. In February 2012 and May 2014, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided to update the sales pack or package insert of domperidone-containing products to include the appropriate safety information related to cardiovascular risk and to tighten the control over the sale of oral domperidone products. So far, the Department of Health (DH) has not received any adverse drug reaction report related to domperidone. DH will remain vigilant on the safety update on domperidone by other overseas drug regulatory authorities.
Ends/Wednesday, Jun 7, 2017
Issued at HKT 16:00
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