The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for December 2019 (PDF).
This month clinicians are advice that domperidone is no longer licensed for use in children younger than 12 years or those weighing less than 35 kg. Results from a placebo-controlled study in children younger than 12 years with acute gastroenteritis failed to demonstrate any difference in efficacy at relieving nausea and vomiting compared with placebo. It is recommended that alternative treatments to domperidone are used in children younger than 12 years of age who need relief of symptoms of nausea and vomiting.
The summary of letters to healthcare professionals this month includes further links to letters recalling ranitidine, Emerade® adrenaline auto-injectors and several other pharmacy level drug recalls.
Action: Clinicians should be aware of this month's new guidance and implement any necessary changes to practice.
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