Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions

  • Procedure started
  • Under evaluation
  • PRAC recommendation
  • CMDh position
  • European Commission final decision
Current status:
Position provided by CMDh

Overview

CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins

Current formulations containing lactose will be replaced with lactose-free formulations

The CMDh1 has endorsed the recommendation of EMA's Pharmacovigilance Risk Assessment Committee (PRAC) that methylprednisolone injections containing lactose (milk sugar), which potentially contain traces of cow's milk proteins, must not be used in patients with a known or suspected allergy to the proteins in cow's milk.

CMDh further confirmed that patients being treated with methylprednisolone for an allergic reaction should have their treatment stopped if their symptoms worsen or they develop new symptoms. Methylprednisolone injections are used to treat the symptoms of severe allergic reactions and other inflammatory conditions. The review of these medicines was triggered following reports of serious allergic reactions such as bronchospasm (excessive contraction of the airway muscles causing
breathing difficulty) and anaphylaxis (sudden severe allergic reaction) with these medicines in patients allergic to cow's milk proteins. The review found that methylprednisolone injections containing lactose derived from cow's milk may also contain traces of cow's milk proteins which can trigger allergic reactions. This is of particular concern in patients already being treated for an allergic reaction as they are more prone to developing new allergic reactions. In this case it may be difficult to determine whether the patient's symptoms are due to a new allergic reaction caused by methylprednisolone products containing lactose or due to a worsening of the original condition. This may lead to additional doses being given which will further worsen the patient's condition.

CMDh agreed with the PRAC's conclusion that there is no level of cow's milk proteins that can be considered safe for these medicines when used to treat severe allergic reactions. Considering that methylprednisolone is used for the treatment of severe allergic reactions in an emergency setting where details of the patients' allergies may not always be known, the CMDh confirmed that the most effective way of minimising any risks is to remove cow's milk proteins from the preparation.

Companies have been asked to provide data allowing the replacement of formulations containing lactose from cow's milk; this data should be provided by the middle of 2019.

In the meantime, the product information will be revised to reflect that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins. In addition, the vial and packaging of these medicines will be clearly marked with a warning against use in patients with cow's milk allergy.


1The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) is a medicines regulatory body representing the European Union (EU) Member States, as well as Iceland, Liechtenstein and Norway.

Key facts

About this medicine
Approved name
Medicinal products containing lactose of bovine origin for IV/IM use in acute allergic reactions
International non-proprietary name (INN) or common name
methylprednisolone
About this procedure
Current status
Position provided by CMDh
Reference number
EMEA/H/A-31/1449
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Decision making model
PRAC-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
Procedure start date
01/12/2016
PRAC recommendation date
06/07/2017
CHMP opinion/CMDh position date
31/07/2017
Outcome
Variation

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Lactose of bovine origin Article-31 referral - CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins (PDF/90.17 KB)

    Adopted

    First published: 01/08/2017
    Last updated: 04/09/2017
    EMA/443893/2017

  • List item

    Lactose of bovine origin Article-31 referral - Annex IV (PDF/20.59 KB)


    First published: 04/09/2017
    Last updated: 04/09/2017

  • List item

    Lactose of bovine origin Article-31 referral - Annex II (PDF/50.81 KB)


    First published: 04/09/2017
    Last updated: 04/09/2017

  • List item

    Lactose of bovine origin Article-31 referral - PRAC assessment report (PDF/176.17 KB)

    Adopted

    First published: 08/08/2017
    Last updated: 08/08/2017
    EMA/459263/2017

  • List item

    Lactose of bovine origin Article-31 referral - CMDh confirms that methylprednisolone injections containing lactose must not be given to patients allergic to cow's milk proteins (PDF/90.17 KB)

    Adopted

    First published: 01/08/2017
    Last updated: 04/09/2017
    EMA/443893/2017

  • List item

    Lactose of bovine origin Article-31 referral - Annex III (PDF/38.77 KB)


    First published: 01/08/2017
    Last updated: 04/09/2017

  • List item

    Lactose of bovine origin Article-31 referral - Annex I (PDF/110.46 KB)


    First published: 06/12/2016
    Last updated: 04/09/2017
    EMA/818613/2016

  • Document description

    • Annex I - List of the medicines affected by the referral
    • Annex II - Scientific conclusions of the CHMP or CMDh
    • Annex III - Changes to the summary of product characteristics, labelling or package leaflet - available when the CHMP or CMDh recommends changes to the product information. Also includes conditions for lifting of suspensions, if applicable
    • Annex IV - Conditions of the marketing authorisation - available when the CHMP or CMDh recommends other measures to be taken for the marketing authorisation such as safety measures or additional studies
    • Notification - A letter from a Member State, the European Commission or a marketing-authorisation holder requesting the initiation of a referral procedure
    • Rationale for triggering - Background provided by the party triggering the referral explaining the issues leading to the initiation of the procedure
    • PRAC list of questions - Questions agreed by the PRAC requesting further information to evaluate the issues identified
    • PRAC timetable - Timeframe agreed by the PRAC to receive information, assess the issues and adopt a recommendation
    • PRAC / CHMP or CMDh assessment report - The assessment and conclusions of the PRAC and CHMP or CMDh on the issues investigated

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