(AGENPARL) – ven 10 febbraio 2023 10 February 2023
Media and Public Relations
News announcement
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6-9 February
PRAC starts a 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the marketing authorisations for pseudoephedrine-containing medicines should be maintained, varied, suspended or withdrawn across the European Union (EU).
Pseudoephedrine-containing medicines are authorised in various EU Member States alone, or in combination with medicines to treat symptoms of a cold and flu such as headache, fever and pain, or allergic rhinitis (inflammation of the nasal passages) in people with nasal congestion.
More information is available in [EMA’s public health communication.](https://link.mediaoutreach.meltwater.com/ls/click?upn=eR8gA2rSMGyvDZC4ShthtIfMhRs-2BEGfuPOqTkc00h0GNsuhKbwvKeYQbR1x15NyjHMq4xb1a8YWj31oz8TXByR6R4pqPXza2CUXKuGiZiLnljIqClSHB-2BlsshQMACDx69nv-2BcJQucMPA8bcuRlMT4A-3D-3D4JqL_mLoYh0p4AWg4foFr5HgrZ1QioQ33bLwdnQ-2BsYGKFX9mv8wVBOgi5GpVq-2FNhlrfTlX9L-2BS1vA2QXwHmqtsL-2BrQOvRw3CzioWUrjOOTPQmRkGlFdW82nbIfwPJFbqZt34sAT4Zg9yqw-2FuaWFB54yz3G1mPZ3ZWtqJXjgeFEPSCvHlHRLuWigZKU4ykq3Sn7VKaV-2Fs-2F4lEeuN4Aow3J93psfWTqZYStNP2RYLnKsxF521Lx7mywSk9EZWDffVZt2dtTIGF8Ma3fxBgf23SJNMj0hKQEGgWZ-2FKtgu2F3P9N5iRo7SqBpW6YnYvTM3K-2BhMXU3auvQa6pFQBjvdx-2FO-2FjaXFpt-2FHgWjrhaC6-2BuR7B88j0sV52EZE2GV380XiBBM3xw-2Fl2WsFUKnxWDvoFUoxMQeTw-3D-3D)
Ongoing referrals
Procedure
Status
Update
[Topiramate – Article-31 referral](https://link.mediaoutreach.meltwater.com/ls/click?upn=eR8gA2rSMGyvDZC4ShthtIfMhRs-2BEGfuPOqTkc00h0EwdDLDHEyn-2BJRfREriQSR7WxUtsD-2Fz7YdxByN-2BIRkf9Lb7n7DjKNXD3uquT-2F8AYUE-3DsPue_mLoYh0p4AWg4foFr5HgrZ1QioQ33bLwdnQ-2BsYGKFX9mv8wVBOgi5GpVq-2FNhlrfTlX9L-2BS1vA2QXwHmqtsL-2BrQOvRw3CzioWUrjOOTPQmRkGlFdW82nbIfwPJFbqZt34sAT4Zg9yqw-2FuaWFB54yz3G1mPZ3ZWtqJXjgeFEPSCvHlHRLuWigZKU4ykq3Sn7VKaV-2Fs-2F4lEeuN4Aow3J93psfXbxZvKUf-2BT-2B-2F2tykKgcGjMh8IzE9CBUKeb5kJ7m5c5nlE5XSP-2FIq4GCOF-2FG1jJEKbgUka97jFAwCCNeRFXzUVVljcLVBrbIZL-2B6d-2F0lvX6hNHShJz1j1HoUiMasXJCda7weE2XR9LFJmBctzUrf-2FUbmYyJa4oSk48VHBvQOcpAqYs1VtSkCjaq7EtkO-2FFeqcw-3D-3D)
Under evaluation
PRAC continued its assessment.
Contact
EMA press office