Numeta G13%E and Numeta G16%E emulsion for infusion

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

Overview


Numeta G13%E to be suspended and new risk minimisation measures to be introduced for Numeta G16%E

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh), a medicines regulatory body representing the European Union (EU) Member States, has endorsed by consensus the recommendation to suspend the marketing authorisation of Numeta G13%E because of a risk of hypermagnesaemia (high blood levels of magnesium). Numeta G13%E, which is given into a vein to premature babies to provide nutritional support (intravenous nutrition or parenteral nutrition), will remain suspended until a reformulated preparation is made available.

For another nutrition preparation given into a vein, Numeta G16%E, used in full-term newborns and children up to two years, the CMDh agreed that the benefit-risk balance remains positive, provided that healthcare professionals monitor their patients' blood magnesium levels before giving the preparation and at appropriate intervals thereafter in accordance with routine clinical practice and the clinical needs of the individual patient. In patients whose blood magnesium levels are elevated or signs of hypermagnesaemia are identified, Numeta G16%E should be stopped or the infusion rate reduced.

Numeta preparations are given to provide nutritional support in children who cannot be fed by mouth or with a feeding tube. They contain nutrients such as glucose (sugar), lipids (fats), amino acids and other important substances including magnesium.

Hypermagnesaemia is a serious condition and symptoms may include weakness, nausea and vomiting, breathing difficulties, hypotension (low blood pressure) and arrhythmias (irregular heart beat).

The review of Numeta G13%E and Numeta G16%E was carried out by the the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) following several reports of hypermagnesaemia (without clinical symptoms) in preterm infants. As a precautionary measure, the manufacturer decided to voluntarily recall Numeta G13%E in the EU. The PRAC assessed the available data on the risk of hypermagnesaemia with Numeta G13%E and Numeta G16%E preparations from clinical studies, post-marketing reports and the published literature and considered available treatment guidelines. Stakeholders were also invited to submit any relevant information to support the assessment, and the Agency's Paediatric Committee (PDCO) was consulted for advice.

Having considered available guidelines and relevant literature and considering the magnesium content of Numeta, the PRAC concluded that the administration of Numeta G13%E could lead to a higher risk of hypermagnesaemia. In addition, the PRAC noted that this risk is further increased in premature newborns because their kidneys are immature and less able to clear the body of magnesium. The PRAC also noted the difficulty in identifying symptoms of hypermagnesaemia in premature newborns, which means that hypermagnesaemia may not be detected until it causes serious complications.

For Numeta G16%E, the PRAC concluded that although the magnesium content may result in a magnesium intake that is slightly higher than suggested in some guidelines, the proposed measures, including updating the product information and a further study, are sufficient to ensure the safe use of this product. The product information should be revised accordingly and healthcare professionals should be informed in writing of the potential risk of hypermagnesaemia, which is increased in patients with impaired kidney function and those whose mothers were receiving supplemental magnesium before delivery, and of the measures to be taken to minimise this risk. In addition, the PRAC recommended a study be carried out to further evaluate blood magnesium levels observed in term newborn infants and children up to two years of age following use of Numeta G16%E.

As the PRAC recommendations were endorsed by consensus by the CMDh, they will now be implemented directly in all Member States, according to an agreed timetable.

Key facts

About this medicine
Approved name
Numeta G13%E and Numeta G16%E emulsion for infusion
Class
-
About this procedure
Current status
Position provided by CMDh
Reference number
EMEA/H/A-107i/1373
Type
Article 107i procedures

This type of procedure is triggered when a Member State or the European Commission consider that urgent action is necessary because of a safety issue. Situations that fall under this procedure include consideration for suspension or revocation of the marketing authorisation for a medicine, the prohibition of supply of a medicine or major changes to the marketing authorisation such as deletion of indications, reduction of the recommended dose or new contraindications. The procedure is also applicable in case of a safety issue with a class of medicines.

Decision making model
PRAC-CMDh
Authorisation model
Nationally authorised product(s)
Key dates and outcomes
Procedure start date
13/06/2013
PRAC recommendation date
05/09/2013
CHMP opinion/CMDh position date
18/09/2013
Outcome
Suspension

Data submission

The Agency invites all stakeholders (e.g. healthcare professionals, patients' organisations and the general public) to submit data relevant to this procedure. This is in accordance with Article 107j(1) of Directive 2001/83/EC.

The following requirements apply for data to be considered:

  • Submissions must be accompanied by the submission form below, with all fields completed. The form must be used with Adobe Reader X+ or Adobe Acrobat X+:
    PDF iconStakeholder's submission form
  • The submission of all data should take place by 1 July 2013.

Submitting data

Send the completed form electronically to the stakeholders' submission inbox (public@ema.europa.eu). Specify the name of the medicine in the subject line of the e-mail.

The size of the submission file should not exceed 25 MB. If your attempt to send your data package to the dedicated e-mail address is unsuccessful, please use alternative submission means.

It is of the utmost importance that data are provided promptly, to avoid undermining the safety review. Due to the urgent nature of the procedure, you are strongly advised to submit your data in English.

Protection of personal data

Personal data submitted are subject to data-protection rules as established by Regulation (EC) 45/2001. They will be treated in accordance with the PDF iconspecific privacy statement for public consultations .

Treatment and publication of data

Data submitted will be received and recorded by the Agency.

The Agency will prepare a list of all submissions received, which will be published as an annex to the PRAC assessment report for transparency purposes and public awareness.

Please note that all data submitted in the context of this procedure may be shared and disclosed in the public domain.

All documents

Procedure started

Recommendation provided by Pharmacovigilance Risk Assessment Committee

Position provided by CMDh

  • List item

    Numeta G13%E to be suspended and new risk-minimisation measures to be introduced for Numeta G16%E (PDF/85.51 KB)


    First published: 20/09/2013
    Last updated: 20/09/2013
    EMA/564255/2013

  • List item

    Numeta Article-107i procedure - Annex V (PDF/22.75 KB)


    First published: 27/09/2013
    Last updated: 27/09/2013
    EMEA/H/A-107i/1373

  • List item

    Numeta Article-107i procedure - Annex VI (PDF/25.97 KB)


    First published: 27/09/2013
    Last updated: 27/09/2013
    EMEA/H/A-107i/1373

  • List item

    Numeta Article-107i procedure - Annex III (PDF/19.47 KB)


    First published: 27/09/2013
    Last updated: 27/09/2013
    EMEA/H/A-107i/1373

  • List item

    Numeta Article-107i procedure - Annex II (PDF/80.46 KB)


    First published: 27/09/2013
    Last updated: 27/09/2013
    EMEA/H/A-107i/1373

  • List item

    Numeta Article-107i procedure - Annex I (PDF/88.99 KB)


    First published: 27/09/2013
    Last updated: 27/09/2013
    EMEA/H/A-107i/1373

  • List item

    Numeta Article-107i procedure - Annex IV (PDF/53.85 KB)


    First published: 27/09/2013
    Last updated: 27/09/2013
    EMEA/H/A-107i/1373

  • List item

    Numeta G13%E to be suspended and new risk-minimisation measures to be introduced for Numeta G16%E (PDF/85.51 KB)


    First published: 20/09/2013
    Last updated: 20/09/2013
    EMA/564255/2013

  • List item

    Numeta Article-107i procedure - Amendments to relevant sections of the summary of product characteristics and package leaflet (PDF/28.69 KB)


    First published: 20/09/2013
    Last updated: 20/09/2013

  • 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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