{"id":12582,"date":"2026-08-28T14:24:44","date_gmt":"2026-08-28T07:24:44","guid":{"rendered":"https:\/\/quoctesannhihaiphong.vn\/en\/medication-news-point-06-2024\/"},"modified":"2026-08-28T14:24:44","modified_gmt":"2026-08-28T07:24:44","slug":"medication-news-point-06-2024","status":"publish","type":"post","link":"https:\/\/quoctesannhihaiphong.vn\/en\/medication-news-point-06-2024\/","title":{"rendered":"MEDICATION NEWS POINT 06.2024"},"content":{"rendered":"<p><strong>1. WARNING REITERATING THE RISK OF ADVERSE NEUROLOGICAL EVENTS WHEN USING MONTELUKAST<\/strong><\/p>\n<p>Montelukast is a prescription medication widely used in the treatment of asthma and seasonal allergic rhinitis. Previously, montelukast was considered a medication with few unwanted side effects and was used for long durations (from several months to several years) with specific indications and dosages. However, recently the MHRA (Medicines and Healthcare products Regulatory Agency) has issued a warning reiterating the risk of adverse neurological health events when using montelukast in all patients (including children and adolescents).<\/p>\n<p><strong>1.1 Warnings from Regulatory Agencies Regarding the Neuropsychiatric Events of Montelukast<\/strong><\/p>\n<p>In March 2008, the FDA (U.S. Food and Drug Administration) conducted the first review of the initial relationship between montelukast and mood changes, behavior as well as suicidal thoughts and behaviors in users.<\/p>\n<p>In 2008, the MHRA required the inclusion of information about neuropsychiatric events in the product information of medications containing montelukast.<\/p>\n<p>In June 2009, the FDA required updates to the prescribing information for montelukast, warning about neuropsychiatric events such as agitation, aggression, anxiety, abnormal dreams, nightmares, and hallucinations,Depression and insomnia, discomfort, restlessness, suicidal thoughts and actions.<\/p>\n<p>In April 2013, TGA (Therapeutic Goods Administration) issued a warning about the neurological risks of montelukast, including suicidal thoughts, depression, agitation, aggressive behavior, hallucinations, insomnia, sleepwalking, tremors, etc.<\/p>\n<p>In 2019, MHRA requested the addition of detailed warnings regarding psychiatric events to the product information of montelukast-containing medications. These events include:<\/p>\n<ul>\n<li>Sleep disorders, depression, and agitation, which may be accompanied by aggressive behavior (frequency 1\/100, uncommon)<\/li>\n<li>Attention or memory disorders (frequency 1\/1,000, rare)<\/li>\n<li>Hallucinations, or suicidal thoughts and behaviors (frequency 1\/10,000, very rare)<\/li>\n<\/ul>\n<p>In September 2019, in the Drug Safety Update newsletter, the MHRA reminded healthcare professionals and patients about the risk of neuropsychiatric events associated with montelukast.<\/p>\n<p>In March 2020, the FDA continued to require the addition of a boxed warning regarding serious adverse reactions affecting neurological health, including the risk of suicidal thoughts or actions, while recommending the restriction of montelukast use in the treatment of allergic rhinitis.<\/p>\n<p>On April 29, 2024, the MHRA continued to receive reports of adverse neuropsychiatric events as well as inquiries from patients and caregivers regarding montelukast. Therefore, the MHRA conducted an evaluation of new evidence, considering the concerns of patients and caregivers, and sought independent clinical advice from pediatricians, mental health professionals, respiratory specialists, and drug safety experts from the Committee on Human Medicines. The MHRA reiterated the warning about the risk of adverse neurological events when using montelukast. The most common events across all age groups include sleep disturbances, hallucinations, anxiety, depression, and mood changes. In children under 12 years old, aggressive behavior, nightmares, and anxiety were reported. For adolescents aged 13 to 17, reported events included anxiety, suicidal ideation, and depression. The results of the evaluation dataThe adverse event report indicates a potential lack of awareness among healthcare professionals, patients, and caregivers regarding the risk of neuropsychiatric events when using montelukast. Based on the existing evidence, the Pharmacovigilance Advisory Group (PEAG) recommends discontinuing montelukast as soon as symptoms arise due to the nature of these events, and timely cessation of the medication may help prevent symptoms from worsening. To raise awareness of the risk of neuropsychiatric events associated with montelukast use, a warning about this event will soon be highlighted in the product information in the UK, along with updates on the latest available evidence. Healthcare professionals and patients need to be informed of this information.<\/p>\n<p><strong>1.2 Recommendations for Healthcare Professionals<\/strong><\/p>\n<ul>\n<li>Be aware of the neuropsychiatric adverse reactions of montelukast, especially in cases where patients are newly starting treatment or considering dose increases. Pay attention to cases involving children.<\/li>\n<li>Assess the patient&#8217;s psychiatric history before treatment.<\/li>\n<li>Consider the risks and benefits when deciding to prescribe or continue the medication for the patient.<\/li>\n<li>Advise all patients about neuropsychiatric events when montelukast is prescribed.<\/li>\n<li>Monitor neuropsychiatric signs in all patients treated with montelukast.<\/li>\n<\/ul>\n<p><strong><em>References<\/em><\/strong><\/p>\n<p>Electronic information page of the National DI and ADR Center, <em>Reminder warning about the risk of adverse neuropsychiatric events when using montelukast<\/em>, accessed on May 18, 2024, link: <a href=\"http:\/\/canhgiacduoc.org.vn\/CanhGiacDuoc\/DiemTin\/2531\/MHRA-nguy-co-gap-bien-co-bat-loi-tam-than-kinh-khi-su-dung-montelukast.htm?fbclid=IwZXh0bgNhZW0CMTAAAR0I4nRtUMvt2C-ZOyRHlVuU0aH1mPFHmI0NyC0nSVIjnQ-shdxK6CSgtws_aem_AdIXX1JSQAqX33b2scw-pqU_qgXXAcYqbiz7SKrW_ClGSk3cO0QrAnLZOsKK0qRcZriJ2t-Vbuvj0ICrmDjegSpj\">http:\/\/canhgiacduoc.org.vn\/CanhGiacDuoc\/DiemTin\/2531\/MHRA-nguy-co-gap-bien-co-bat-loi-tam-than-kinh-khi-su-dung-montelukast.htm?fbclid=IwZXh0bgNhZW0CMTAAAR0I4nRtUMvt2C-ZOyRHlVuU0aH1mPFHmI0NyC0nSVIjnQ-shdxK6CSgtws_aem_AdIXX1JSQAqX33b2scw-pqU_qgXXAcYqbiz7SKrW_ClGSk3cO0QrAnLZOsKK0qRcZriJ2t-Vbuvj0ICrmDjegSpj<\/a><\/p>\n<p>FDA electronic information page, accessed on May 18, 2024, link:<a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug\"><a href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug\">https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug<\/a><\/p>\n<p><strong>2. GUIDELINES FOR INTRAVENOUS ALBUMIN USE BY ICTMG<\/strong><\/p>\n<p>Albumin is used in many clinical settings to improve hemodynamics, assist in fluid aspiration, and manage complications of cirrhosis. According to ICTMG (International Collaborative Group on Treatment Guidelines in Blood Transfusion), guidelines for the use of albumin have been developed for patients requiring intensive care, post-cardiac surgery patients, those undergoing renal replacement therapy, or those experiencing complications of cirrhosis.<\/p>\n<p><strong>Method: <\/strong>The responsible members of the Collaborative Group supervised the guideline development process, and the guideline development council included researchers, clinical physicians, methodologists, and patient representatives. The treatment guidelines utilize evidence from a systematic review of randomized clinical trials and systematic reviews assessed across multiple databases (as of November 23, 2022). The council evaluated the data and formulated guidelines using the &#8220;assess, develop, and classify recommendations&#8221; method. The guidelines were revised after consultation.community.<\/p>\n<p><strong>Results: <\/strong>The workshop provided 14 recommendations regarding the use of albumin, including 1 recommendation in pediatric intensive care (with low evidence level) and 2 recommendations in neonatal intensive care (with very low evidence level).<\/p>\n<p><strong>Table 1: Recommendations for intravenous albumin use in children<\/strong><\/p>\n<table width=\"624\">\n<thead>\n<tr>\n<td width=\"48\">No.<\/td>\n<td width=\"372\">Recommendation<\/td>\n<td width=\"102\">Recommendation Level<\/td>\n<td width=\"102\">Evidence Level<\/td>\n<\/tr>\n<tr>\n<td width=\"48\">1<\/td>\n<td width=\"372\">In pediatric patients with infection and reduced perfusion, intravenous albumin is not recommended to reduce mortality.<\/td>\n<td width=\"102\">Strong<\/td>\n<td width=\"102\">Low<\/td>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td width=\"48\">2<\/td>\n<td width=\"372\">In <strong>premature infants<\/strong> (\u2264 36 weeks) with low serum albumin levels and respiratory distress, intravenous albumin is <strong>not<\/strong> recommended to improve respiratory function.<\/td>\n<td width=\"102\">Conditional recommendation<\/td>\n<td width=\"102\">Very low<\/td>\n<\/tr>\n<tr>\n<td width=\"48\">3<\/td>\n<td width=\"372\">In <strong>premature newborns<\/strong> (\u2264 32 weeks or \u2264 1.5 kg) with or without reduced perfusion, intravenous albumin <strong>is not<\/strong> recommended as a solution to increase circulating volume.<\/td>\n<td width=\"102\">Conditional recommendation<\/td>\n<td width=\"102\">Very low<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><strong>Conclusion:<\/strong> Currently, there is very little evidence-based indication for the routine use of albumin in clinical practice to improve patient outcomes. This treatment guideline provides clinicians with useful recommendations regarding the use of albumin.<\/p>\n<p><strong><em>References:<\/em><\/strong><br \/>\nNational DI and ADR Center website, <em>ICTMG: Guidelines for the use of intravenous albumin, <\/em>accessed on May 18, 2024, link: <a href=\"http:\/\/canhgiacduoc.org.vn\/CanhGiacDuoc\/DiemTin\/2530\/ICTMG-huong-dan-su-dung-albumin-duong-tinh-mach.htm\"><em>http:\/\/canhgiacduoc.org.vn\/CanhGiacDuoc\/DiemTin\/2530\/ICTMG-huong-dan-su-dung-albumin-duong-tinh-mach.htm<\/em><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>1. WARNING REITERATING THE RISK OF ADVERSE NEUROLOGICAL EVENTS WHEN USING MONTELUKAST Montelukast is a prescription medication widely used in the treatment of asthma and seasonal allergic rhinitis. Previously, montelukast was considered a medication with few unwanted side effects and was used for long durations (from several months to several years) with specific indications and<\/p>\n","protected":false},"author":11,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1161],"tags":[1275,1276,1274,1176,1278,1273,1277,1279],"class_list":["post-12582","post","type-post","status-publish","format-standard","hentry","category-ban-tin-duoc","tag-albumin-duong-tinh-mach","tag-an-toan-su-dung-thuoc","tag-bien-co-tam-than-kinh","tag-canh-giac-duoc","tag-hen-phe-quan","tag-montelukast","tag-phan-ung-co-hai-cua-thuoc","tag-viem-mui-di-ung"],"_links":{"self":[{"href":"https:\/\/quoctesannhihaiphong.vn\/en\/wp-json\/wp\/v2\/posts\/12582","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/quoctesannhihaiphong.vn\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/quoctesannhihaiphong.vn\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/quoctesannhihaiphong.vn\/en\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/quoctesannhihaiphong.vn\/en\/wp-json\/wp\/v2\/comments?post=12582"}],"version-history":[{"count":0,"href":"https:\/\/quoctesannhihaiphong.vn\/en\/wp-json\/wp\/v2\/posts\/12582\/revisions"}],"wp:attachment":[{"href":"https:\/\/quoctesannhihaiphong.vn\/en\/wp-json\/wp\/v2\/media?parent=12582"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/quoctesannhihaiphong.vn\/en\/wp-json\/wp\/v2\/categories?post=12582"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/quoctesannhihaiphong.vn\/en\/wp-json\/wp\/v2\/tags?post=12582"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}