Update on the efficiency and safety of orally administered nasal decongestants
Nasal congestion leading to obstruction is one of the main symptoms in acute rhinosinusitis (common cold), other upper respiratory infections and allergic rhinitis. The EPOS 2020 guidelines place oral decongestants as an efficient therapy for the relief of nasal obstruction. In Romania, there are m...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Amaltea Medical Publishing House
2023-12-01
|
| Series: | Romanian Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | https://rjid.com.ro/articles/2023.4/RJID_2023_4_Art-01.pdf |
| _version_ | 1827337790457643008 |
|---|---|
| author | Victoria Arama Oana-Alexandra Ganea Daniela Neagu Cleo Rosculet Stefan Sorin Arama |
| author_facet | Victoria Arama Oana-Alexandra Ganea Daniela Neagu Cleo Rosculet Stefan Sorin Arama |
| author_sort | Victoria Arama |
| collection | DOAJ |
| description | Nasal congestion leading to obstruction is one of the main symptoms in acute rhinosinusitis (common cold), other upper respiratory infections and allergic rhinitis. The EPOS 2020 guidelines place oral decongestants as an efficient
therapy for the relief of nasal obstruction. In Romania, there are more than 50 available nasal decongestants, so it is very important for practitioners from all
medical domains to be aware of recent data regarding their effectiveness and safety profile. Recent concerns raised by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the efficacy
and safety of pseudoephedrine (PSE) and phenylephrine (PHE) emphasize the need for informed decision-making in prescribing. Notably, there were concerns raised about the association between PSE, reversible cerebral vasoconstriction syndrome (RCVS) and posterior reversible encephalopathy syndrome (PRES).
EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), recently recommended measures to minimize risks of serious side effects when using medicines containing PSE. PRAC recommends that medicines containing PSE should not be used in patients with severe or uncontrolled hypertension and severe acute or chronic kidney disease or failure. Additionally, PRAC recommends healthcare professionals to counsel patients to discontinue the use of such medicines promptly and seek medical assistance if they experience symptoms suggesting PRES or RCVS, such as sudden onset of severe headache, confusion, vomiting, visual disturbances or seizures. While effectiveness of oral PSE is confirmed by clinical studies, expert consensus is unfavorable to PHE. Both in vitro and in vivo clinical pharmacology data indicate that neither the recommended doses nor higher doses of oral PHE demonstrate efficacy in alleviating symptoms of nasal congestion. |
| first_indexed | 2024-03-07T19:03:04Z |
| format | Article |
| id | doaj.art-198f67b489e647aa8fce428f52648bfa |
| institution | Directory Open Access Journal |
| issn | 1454-3389 2069-6051 |
| language | English |
| last_indexed | 2024-03-07T19:03:04Z |
| publishDate | 2023-12-01 |
| publisher | Amaltea Medical Publishing House |
| record_format | Article |
| series | Romanian Journal of Infectious Diseases |
| spelling | doaj.art-198f67b489e647aa8fce428f52648bfa2024-03-01T11:10:57ZengAmaltea Medical Publishing HouseRomanian Journal of Infectious Diseases1454-33892069-60512023-12-0126412513410.37897/RJID.2023.4.1Update on the efficiency and safety of orally administered nasal decongestantsVictoria Arama0Oana-Alexandra Ganea1Daniela Neagu2Cleo Rosculet3Stefan Sorin Arama4“Carol Davila” University of Medicine and Pharmacy Bucharest, Romania; “Prof. Dr. Matei Bals” National Institute of Infectious Diseases Bucharest, Romania“Carol Davila” University of Medicine and Pharmacy Bucharest, Romania; “Prof. Dr. Matei Bals” National Institute of Infectious Diseases Bucharest, Romania“Prof. Dr. Matei Bals” National Institute of Infectious Diseases Bucharest, Romania“Prof. Dr. Matei Bals” National Institute of Infectious Diseases Bucharest, Romania“Carol Davila” University of Medicine and Pharmacy Bucharest, Romania; “Prof. Dr. Matei Bals” National Institute of Infectious Diseases Bucharest, RomaniaNasal congestion leading to obstruction is one of the main symptoms in acute rhinosinusitis (common cold), other upper respiratory infections and allergic rhinitis. The EPOS 2020 guidelines place oral decongestants as an efficient therapy for the relief of nasal obstruction. In Romania, there are more than 50 available nasal decongestants, so it is very important for practitioners from all medical domains to be aware of recent data regarding their effectiveness and safety profile. Recent concerns raised by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) regarding the efficacy and safety of pseudoephedrine (PSE) and phenylephrine (PHE) emphasize the need for informed decision-making in prescribing. Notably, there were concerns raised about the association between PSE, reversible cerebral vasoconstriction syndrome (RCVS) and posterior reversible encephalopathy syndrome (PRES). EMA’s safety committee, Pharmacovigilance Risk Assessment Committee (PRAC), recently recommended measures to minimize risks of serious side effects when using medicines containing PSE. PRAC recommends that medicines containing PSE should not be used in patients with severe or uncontrolled hypertension and severe acute or chronic kidney disease or failure. Additionally, PRAC recommends healthcare professionals to counsel patients to discontinue the use of such medicines promptly and seek medical assistance if they experience symptoms suggesting PRES or RCVS, such as sudden onset of severe headache, confusion, vomiting, visual disturbances or seizures. While effectiveness of oral PSE is confirmed by clinical studies, expert consensus is unfavorable to PHE. Both in vitro and in vivo clinical pharmacology data indicate that neither the recommended doses nor higher doses of oral PHE demonstrate efficacy in alleviating symptoms of nasal congestion. https://rjid.com.ro/articles/2023.4/RJID_2023_4_Art-01.pdfnasal congestionrhinosinusitisreversible cerebral vasoconstriction syndromeposterior reversible encephalopathy syndrome |
| spellingShingle | Victoria Arama Oana-Alexandra Ganea Daniela Neagu Cleo Rosculet Stefan Sorin Arama Update on the efficiency and safety of orally administered nasal decongestants Romanian Journal of Infectious Diseases nasal congestion rhinosinusitis reversible cerebral vasoconstriction syndrome posterior reversible encephalopathy syndrome |
| title | Update on the efficiency and safety of orally administered nasal decongestants |
| title_full | Update on the efficiency and safety of orally administered nasal decongestants |
| title_fullStr | Update on the efficiency and safety of orally administered nasal decongestants |
| title_full_unstemmed | Update on the efficiency and safety of orally administered nasal decongestants |
| title_short | Update on the efficiency and safety of orally administered nasal decongestants |
| title_sort | update on the efficiency and safety of orally administered nasal decongestants |
| topic | nasal congestion rhinosinusitis reversible cerebral vasoconstriction syndrome posterior reversible encephalopathy syndrome |
| url | https://rjid.com.ro/articles/2023.4/RJID_2023_4_Art-01.pdf |
| work_keys_str_mv | AT victoriaarama updateontheefficiencyandsafetyoforallyadministerednasaldecongestants AT oanaalexandraganea updateontheefficiencyandsafetyoforallyadministerednasaldecongestants AT danielaneagu updateontheefficiencyandsafetyoforallyadministerednasaldecongestants AT cleorosculet updateontheefficiencyandsafetyoforallyadministerednasaldecongestants AT stefansorinarama updateontheefficiencyandsafetyoforallyadministerednasaldecongestants |