Medsafe Restricts Promethazine Use in Young Children

Medsafe, New Zealand's medical regulatory agency, warns against giving promethazine to children under 6 due to high risk of psychiatric side effects. The agency advises restricting promethazine use to adults and children over 6, citing reports of mood and behavioral changes in young children.

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Aqsa Younas Rana
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Medsafe Restricts Promethazine Use in Young Children

Medsafe Restricts Promethazine Use in Young Children

Medsafe, New Zealand's medical regulatory agency, has issued a warning against giving the over-the-counter oral antihistamine promethazine to children under the age of 6. The agency cites the "high risk" of psychiatric side effects, including mood and behavioral changes, as the reason for this restriction. The warning, which applies to the oral form of promethazine sold under the brand name Phenergan, is aimed at healthcare professionals and parents.

Why this matters: This restriction highlights the importance of ongoing monitoring and evaluation of drug safety, especially in vulnerable populations like young children. It also underscores the need for healthcare professionals and parents to be aware of potential side effects and to carefully weigh the risks and benefits of medication use.

Promethazine is a medication commonly used to treat allergies, nausea, and vomiting. However, Medsafe's warning, issued on May 14, 2024, is based on reports of adverse reactions in young children, including mood and behavioral side effects. The agency advises that promethazine is no longer recommended for children under 6 years old and that its use should be restricted to adults and children over 6.

The warning specifically applies to Adiramedica Promethazine 10 and 25 film-coated tablets, among other affected products. Medsafe highlights that children under 6 are at higher risk of experiencing these psychiatric side effects from promethazine. The agency advises healthcare professionals to carefully consider the risks and benefits when prescribing promethazine to children over 6 years old.

Medsafe's warning is part of a broader effort to ensure the safe use of medications in New Zealand. The agency regularly reviews and updates its guidelines for medication use, taking into account emerging evidence and safety concerns. By issuing this warning, Medsafe aims to inform healthcare professionals and parents about the potential risks associated with promethazine use in young children.

The restriction on promethazine use in children under 6 serves as an important reminder for healthcare professionals and parents to carefully consider the potential side effects of medications, especially in young children. Medsafe's warning highlights the need for ongoing monitoring and evaluation of drug safety to protect public health.

Key Takeaways

  • Medsafe warns against giving promethazine to children under 6 due to high risk of psychiatric side effects.
  • Promethazine use restricted to adults and children over 6 due to mood and behavioral changes.
  • Children under 6 at higher risk of experiencing psychiatric side effects from promethazine.
  • Medsafe advises healthcare professionals to weigh risks and benefits when prescribing promethazine to children over 6.
  • Ongoing monitoring and evaluation of drug safety crucial to protect public health, especially in young children.