Pseudoephedrine-containing medicinal products
- Procedure started
- Under evaluation
- PRAC recommendation
- CHMP opinion
- European Commission final decision
Table of contents
Overview
PRAC starts safety review of pseudoephedrine-containing medicines
EMA’s safety committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions affecting blood vessels in the brain. Pseudoephedrine is taken by mouth and is used alone or in combination with other medicines to treat nasal congestion (a blocked nose) resulting from a cold, flu or allergy.
PRES and RCVS can involve reduced blood supply (ischaemia) to the brain and may cause major and life-threatening complications in some cases. Common symptoms associated with PRES and RCVS include headache, nausea and seizures.
The review follows new data from a small number of cases of PRES and RCVS in people using pseudoephedrine-containing medicines which were reported in pharmacovigilance databases and the medical literature.
Pseudoephedrine-containing medicines have a known risk of cardiovascular and cerebrovascular ischaemic events (side effects involving ischaemia in the heart and brain), including stroke and heart attack. Restrictions and warnings are already included in the medicines’ product information to reduce these risks.
Considering the seriousness of PRES and RCVS, the overall safety profile of pseudoephedrine and the indications for which the medicines are approved, the PRAC will review available evidence and decide whether the marketing authorisations for pseudoephedrine-containing medicines should be maintained, varied, suspended or withdrawn across the EU.
Key facts
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About this medicine
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|---|---|
| Approved name |
Pseudoephedrine-containing medicinal products
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| International non-proprietary name (INN) or common name |
pseudoephedrine
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| Class |
Nasal decongestants for systemic use
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About this procedure
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|---|---|
| Current status |
Procedure started
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| Reference number |
EMEA/H/A-31/1526
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| Type | |
| Authorisation model |
Centrally and nationally authorised products (mixed)
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| Decision making model |
PRAC-CHMP-EC
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Key dates and outcomes
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|---|---|
| Procedure start date |
09/02/2023
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All documents
Procedure started
Pseudoephedrine-containing medicines Article-31 referral - Annex I (PDF/573.63 KB) (updated)
First published: 10/02/2023
Last updated: 16/03/2023
EMA/55341/2023 Rev. 1
Pseudoephedrine-containing medicines Article-31 referral - Timetable for the procedure (PDF/108.48 KB)
First published: 10/02/2023
EMA/PRAC/55340/2023
Pseudoephedrine-containing medicines Article-31 referral - Notification (PDF/59.73 KB)
First published: 10/02/2023
Pseudoephedrine-containing medicines Article-31 referral - PRAC List of questions (PDF/127.12 KB)
First published: 10/02/2023
EMA/PRAC/55342/2023
Description of documents published
Please note that some of the listed documents apply only to certain procedures.
- Overview - lay-language summary of the stage of the procedure
- Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
- Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
- List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
- Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
- List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
- List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
- Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
- Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
- Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
- Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
- Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
- Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
- Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
- Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)
Note that older documents may have different titles.