{"id":17060,"date":"2024-11-22T16:19:59","date_gmt":"2024-11-22T17:19:59","guid":{"rendered":"https:\/\/medexperts.pro\/?p=17060"},"modified":"2024-11-22T17:23:35","modified_gmt":"2024-11-22T17:23:35","slug":"f-d-a-some-clonazepam-recalled-over-incorrect-doses-on-labels","status":"publish","type":"post","link":"https:\/\/medexperts.pro\/?p=17060","title":{"rendered":"F.D.A.: Some Clonazepam Recalled Over Incorrect Doses on Labels"},"content":{"rendered":"<div><\/div>\n<p id=\"article-summary\" class=\"css-79rysd e1wiw3jv0\">The drug, known by the brand name Klonopin, is used for panic disorder and seizures.<\/p>\n<section class=\"meteredContent css-1r7ky0e\">\n<div class=\"css-s99gbd StoryBodyCompanionColumn\" data-testid=\"companionColumn-0\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">The maker of clonazepam, a drug commonly prescribed for anxiety and seizures, has expanded its recall of some of the pills after it discovered that they were labeled with the wrong strength, the Food and Drug Administration announced this week.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The drug\u2019s maker, Endo, recalled 16 product lots of clonazepam, a drug best known by the brand name Klonopin. The company said it had not received any reports of adverse events related to the recall.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">Clonazepam is among a class of psychiatric drugs called <a class=\"css-yywogo\" href=\"https:\/\/www.dea.gov\/factsheets\/benzodiazepines#:~:text=What%20are%20Benzodiazepines%3F,Ativan%C2%AE%2C%20and%20Klonopin%C2%AE.\" title rel=\"noopener noreferrer\" target=\"_blank\">benzodiazepines<\/a>, which slow brain activity and can cause sedation or calming effects.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The agency warned that adults and children who inadvertently took a higher dose of clonazepam than prescribed could experience side effects, including \u201csignificant\u201d sedation, confusion, dizziness, diminished reflexes, the loss of muscle control and muscle weakness.<\/p>\n<\/div>\n<\/div>\n<div data-testid=\"Dropzone-1\"><\/div>\n<div class=\"css-s99gbd StoryBodyCompanionColumn\" data-testid=\"companionColumn-1\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">An overdose can also lead to other serious issues, including \u201csignificant, possibly life-threatening, respiratory depression\u201d for patients who have pulmonary disease or for those who are already taking a near-maximum dose of the drug. People who take other medications that cause respiratory depression are also at risk of this, the agency said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">In a statement, Endo said the recall followed an internal quality investigation that identified a potential label problem with a third-party vendor. \u201cOur first priority at Endo is the quality and safety of our products and well-being of patients,\u201d a representative said.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The company <a class=\"css-yywogo\" href=\"https:\/\/www.fda.gov\/safety\/recalls-market-withdrawals-safety-alerts\/endo-usa-inc-issues-voluntary-nationwide-recall-one-lot-clonazepam-orally-disintegrating-tablets-usp\" title rel=\"noopener noreferrer\" target=\"_blank\">first announced<\/a> in July that it would recall one lot of the medication.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The drug is packaged in cartons containing tablets packed into blister strips; the F.D.A. said these strips reflect the correct product strength. The packaging uses the name Par Pharmaceutical, which marketed clonazepam before Endo acquired it, the F.D.A. said<\/p>\n<p class=\"css-at9mc1 evys1bk0\">The number of patients the expanded recall would affect was not immediately clear, but the F.D.A. said that anyone taking clonazepam from the recalled lots should stop and contact a doctor.<\/p>\n<p class=\"css-at9mc1 evys1bk0\">In 2020, the F.D.A. began <a class=\"css-yywogo\" href=\"https:\/\/www.fda.gov\/drugs\/drug-safety-and-availability\/fda-requiring-boxed-warning-updated-improve-safe-use-benzodiazepine-drug-class#:~:text=Health%20Care%20Professionals-,FDA%20is%20requiring%20the%20Boxed%20Warning%20be%20updated%20for%20all,abuse%2C%20misuse%2C%20and%20addiction.\" title rel=\"noopener noreferrer\" target=\"_blank\">requiring<\/a> that packages of clonazepam and other benzodiazepines include a prominent warning about the risk of abuse, addiction and physical withdrawal symptoms.<\/p>\n<\/div>\n<\/div>\n<div data-testid=\"Dropzone-3\"><\/div>\n<div class=\"css-s99gbd StoryBodyCompanionColumn\" data-testid=\"companionColumn-2\">\n<div class=\"css-53u6y8\">\n<p class=\"css-at9mc1 evys1bk0\">In announcing the change, the <a class=\"css-yywogo\" href=\"https:\/\/www.nytimes.com\/2020\/09\/23\/health\/benzodiazepines-fda-warning.html\" title>agency also asked doctors<\/a> to be more careful in prescribing benzodiazepines with opioids or other drugs that depress the central nervous system.<\/p>\n<\/div>\n<\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>The drug, known by the brand name Klonopin, is used for panic disorder and seizures.The maker of clonazepam, a drug commonly prescribed for anxiety and seizures, has expanded its recall of some of the pills after it discovered that they were labeled with the wrong strength, the Food and Drug Administration announced this week.The drug\u2019s maker, Endo, recalled 16 product lots of clonazepam, a drug best known by the brand name Klonopin. The company said it had not received any reports of adverse events related to the recall.Clonazepam is among a class of psychiatric drugs called benzodiazepines, which slow brain activity and can cause sedation or calming effects.The agency warned that adults and children who inadvertently took a higher dose of clonazepam than prescribed could experience side effects, including \u201csignificant\u201d sedation, confusion, dizziness, diminished reflexes, the loss of muscle control and muscle weakness.An overdose can also lead to other serious issues, including \u201csignificant, possibly life-threatening, respiratory depression\u201d for patients who have pulmonary disease or for those who are already taking a near-maximum dose of the drug. People who take other medications that cause respiratory depression are also at risk of this, the agency said.In a statement, Endo said the recall followed an internal quality investigation that identified a potential label problem with a third-party vendor. \u201cOur first priority at Endo is the quality and safety of our products and well-being of patients,\u201d a representative said.The company first announced in July that it would recall one lot of the medication.The drug is packaged in cartons containing tablets packed into blister strips; the F.D.A. said these strips reflect the correct product strength. The packaging uses the name Par Pharmaceutical, which marketed clonazepam before Endo acquired it, the F.D.A. saidThe number of patients the expanded recall would affect was not immediately clear, but the F.D.A. said that anyone taking clonazepam from the recalled lots should stop and contact a doctor.In 2020, the F.D.A. began requiring that packages of clonazepam and other benzodiazepines include a prominent warning about the risk of abuse, addiction and physical withdrawal symptoms.In announcing the change, the agency also asked doctors to be more careful in prescribing benzodiazepines with opioids or other drugs that depress the central nervous system.<\/p>\n","protected":false},"author":1,"featured_media":17062,"comment_status":"close","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-17060","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lifestyle"],"_links":{"self":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/17060","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=17060"}],"version-history":[{"count":2,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/17060\/revisions"}],"predecessor-version":[{"id":17063,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/posts\/17060\/revisions\/17063"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=\/wp\/v2\/media\/17062"}],"wp:attachment":[{"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=17060"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=17060"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medexperts.pro\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=17060"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}