Kids Should Not Take Drugs Containing Codeine or Tramadol, FDA Says
Half of Americans Take Prescription Drugs That Could Lead to Addiction
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The agency cited evidence that the drugs could cause dangerously slowed breathing in some children, which could lead to death.\u003c/p>\n\u003cp>Multiple prescription drugs contain codeine or tramadol. For example, the painkiller Tylenol 3 contains acetaminophen and codeine. Drugs containing codeine already carry a black-box warning against using it to treat pain in children who have their tonsils removed.\u003c/p>\n\u003cp>\"This is something we've been watching for several years,\" says Douglas Throckmorton, the deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research. \"They are powerful, effective medicines when used right [but] they can cause a lot of harm when they're not.\"\u003c/p>\n\u003cp>The agency also warned against using the drugs in young people between 12 and 18 who are obese or have breathing problems such as sleep apnea or lung disease.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>The new warnings did not further restrict over-the-counter medicines that contain codeine, such as popular types of cough syrup and medication marketed for cold and flu symptoms. The FDA recommends that parents talk to a doctor before giving their children such drugs and notes that colds and coughs in kids \"are generally mild and go away in a few days, so they may not need to take any medicine.\"\u003c/p>\n\u003cp>Thursday's announcement was a partial acceptance of 2015 recommendations by an independent advisory committee that recommended the agency restrict prescription of codeine-containing drugs for children and also voted overwhelmingly against over-the-counter sale of codeine-containing cough syrup for children.\u003c/p>\n\u003cp>At the time, pharmacist Maria Pruchnicki, an associate professor at the Ohio State University College of Pharmacy, told NPR's Rob Stein, \"My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them.\"\u003c/p>\n\u003cp>As Stein reported, the FDA is not required to follow the committee's 2015 advice, although the agency generally acts in line with advisory committee recommendations.\u003c/p>\n\u003cp>In this case, the agency did act on prescription drugs but did not act on the over-the-counter recommendation.\u003c/p>\n\u003cp>It was unclear why more than a year passed between the committee recommendations and their partial adoption by the agency. In a press briefing, Throckmorton said the agency had received \"additional information.\"\u003c/p>\n\u003cp>Diana Zuckerman, president of the consumer group National Center for Health Research, called the move a \"long-overdue step to protect our children\":\u003c/p>\n\u003cp>\"The science is clear, so why did it take almost 18 months since the FDA's public meeting on the exact same issue? FDA needs to do more to warn patients about the known risks of medical products as soon as data are available. A change in the label is important, but unfortunately many doctors and patients don't read these labels. We need a public education campaign to warn parents and nursing women about these risks.\"\u003c/p>\n\u003cp>In 2015, the FDA acknowledged that although tramadol is not approved for use in children, it is used off-label to treat pain in kids. In that warning, the agency noted that some people are what's known as ultra-rapid metabolizers of tramadol and codeine. Those people have a variant of a liver enzyme that breaks down the drugs more quickly, leading to a rapid and potentially dangerous spike in the level of active opioids in the bloodstream.\u003c/p>\n\u003cp>The drugs can make their way into breast milk in nursing mothers and potentially harm infants, the FDA warns. The proportion of people with the enzyme variant, which is genetic, is thought to be between 1 and 10 percent.\u003c/p>\n\u003cp>\"Because we can't easily determine which children or nursing mothers specifically are at greater risk of ultra-rapid metabolism of codeine or tramadol, we are requiring manufacturers ... to make important labeling changes to protect those children who are at the greatest risk,\" explains Throckmorton.\u003c/p>\n\u003cp>As for future action on over-the-counter medicines that contain codeine, the American Academy of Pediatrics has made its position clear.\u003c/p>\n\u003cp>In a report published last year in the journal Pediatrics, members of the academy's committee on drugs wrote that although over-the-counter cough and cold medicines containing codeine were available in 28 states and Washington, D.C., \"neither the value of suppressing cough nor the effectiveness of codeine in children with acute illnesses has been shown.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Regulators in Europe, Canada and Australia have all restricted the use of medicines containing codeine for children. According to the FDA's public label database, more than 100 medications containing codeine are approved for sale without a prescription in the U.S.\u003c/p>\n\n","blocks":[],"excerpt":"The drugs, used to treat things like coughs or pain, could cause dangerously slowed breathing in some children.\r\n","status":"publish","parent":0,"modified":1492793784,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":21,"wordCount":827},"headData":{"title":"Kids Should Not Take Drugs Containing Codeine or Tramadol, FDA Says | KQED","description":"The drugs, used to treat things like coughs or pain, could cause dangerously slowed breathing in some children.\r\n","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"320798 https://ww2.kqed.org/stateofhealth/?p=320798","disqusUrl":"https://ww2.kqed.org/stateofhealth/2017/04/21/kids-should-not-take-drugs-containing-codeine-or-tramadol-fda-says/","disqusTitle":"Kids Should Not Take Drugs Containing Codeine or Tramadol, FDA Says","nprByline":"Rebecca Hersher\u003cbr />\u003ca href=\"http://www.npr.org/sections/health-shots/\">NPR Shots\u003c/a> ","path":"/stateofhealth/320798/kids-should-not-take-drugs-containing-codeine-or-tramadol-fda-says","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>The Food and Drug Administration says children under 12 should not be given prescription medicines that contain codeine or another narcotic, tramadol, and that such drugs can also be dangerous to youth between 12 and 18.\u003c/p>\n\u003cp>On Thursday, the FDA said it will require that prescription drugs containing codeine or tramadol carry a warning on the label against using them in children under 12 or in women who are breast-feeding. The agency cited evidence that the drugs could cause dangerously slowed breathing in some children, which could lead to death.\u003c/p>\n\u003cp>Multiple prescription drugs contain codeine or tramadol. For example, the painkiller Tylenol 3 contains acetaminophen and codeine. Drugs containing codeine already carry a black-box warning against using it to treat pain in children who have their tonsils removed.\u003c/p>\n\u003cp>\"This is something we've been watching for several years,\" says Douglas Throckmorton, the deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research. \"They are powerful, effective medicines when used right [but] they can cause a lot of harm when they're not.\"\u003c/p>\n\u003cp>The agency also warned against using the drugs in young people between 12 and 18 who are obese or have breathing problems such as sleep apnea or lung disease.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>The new warnings did not further restrict over-the-counter medicines that contain codeine, such as popular types of cough syrup and medication marketed for cold and flu symptoms. The FDA recommends that parents talk to a doctor before giving their children such drugs and notes that colds and coughs in kids \"are generally mild and go away in a few days, so they may not need to take any medicine.\"\u003c/p>\n\u003cp>Thursday's announcement was a partial acceptance of 2015 recommendations by an independent advisory committee that recommended the agency restrict prescription of codeine-containing drugs for children and also voted overwhelmingly against over-the-counter sale of codeine-containing cough syrup for children.\u003c/p>\n\u003cp>At the time, pharmacist Maria Pruchnicki, an associate professor at the Ohio State University College of Pharmacy, told NPR's Rob Stein, \"My concern, were I to be prescribing codeine in children, would be that I would, frankly, kill them.\"\u003c/p>\n\u003cp>As Stein reported, the FDA is not required to follow the committee's 2015 advice, although the agency generally acts in line with advisory committee recommendations.\u003c/p>\n\u003cp>In this case, the agency did act on prescription drugs but did not act on the over-the-counter recommendation.\u003c/p>\n\u003cp>It was unclear why more than a year passed between the committee recommendations and their partial adoption by the agency. In a press briefing, Throckmorton said the agency had received \"additional information.\"\u003c/p>\n\u003cp>Diana Zuckerman, president of the consumer group National Center for Health Research, called the move a \"long-overdue step to protect our children\":\u003c/p>\n\u003cp>\"The science is clear, so why did it take almost 18 months since the FDA's public meeting on the exact same issue? FDA needs to do more to warn patients about the known risks of medical products as soon as data are available. A change in the label is important, but unfortunately many doctors and patients don't read these labels. We need a public education campaign to warn parents and nursing women about these risks.\"\u003c/p>\n\u003cp>In 2015, the FDA acknowledged that although tramadol is not approved for use in children, it is used off-label to treat pain in kids. In that warning, the agency noted that some people are what's known as ultra-rapid metabolizers of tramadol and codeine. Those people have a variant of a liver enzyme that breaks down the drugs more quickly, leading to a rapid and potentially dangerous spike in the level of active opioids in the bloodstream.\u003c/p>\n\u003cp>The drugs can make their way into breast milk in nursing mothers and potentially harm infants, the FDA warns. The proportion of people with the enzyme variant, which is genetic, is thought to be between 1 and 10 percent.\u003c/p>\n\u003cp>\"Because we can't easily determine which children or nursing mothers specifically are at greater risk of ultra-rapid metabolism of codeine or tramadol, we are requiring manufacturers ... to make important labeling changes to protect those children who are at the greatest risk,\" explains Throckmorton.\u003c/p>\n\u003cp>As for future action on over-the-counter medicines that contain codeine, the American Academy of Pediatrics has made its position clear.\u003c/p>\n\u003cp>In a report published last year in the journal Pediatrics, members of the academy's committee on drugs wrote that although over-the-counter cough and cold medicines containing codeine were available in 28 states and Washington, D.C., \"neither the value of suppressing cough nor the effectiveness of codeine in children with acute illnesses has been shown.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>Regulators in Europe, Canada and Australia have all restricted the use of medicines containing codeine for children. According to the FDA's public label database, more than 100 medications containing codeine are approved for sale without a prescription in the U.S.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/320798/kids-should-not-take-drugs-containing-codeine-or-tramadol-fda-says","authors":["byline_stateofhealth_320798"],"categories":["stateofhealth_14"],"tags":["stateofhealth_2850","stateofhealth_3081","stateofhealth_2892","stateofhealth_48","stateofhealth_2808","stateofhealth_3082","stateofhealth_2519","stateofhealth_2888"],"featImg":"stateofhealth_320813","label":"stateofhealth"},"stateofhealth_234838":{"type":"posts","id":"stateofhealth_234838","meta":{"index":"posts_1591205157","site":"stateofhealth","id":"234838","score":null,"sort":[1473378786000]},"guestAuthors":[],"slug":"half-of-americans-take-prescription-drugs-that-could-lead-to-addiction","title":"Half of Americans Take Prescription Drugs That Could Lead to Addiction","publishDate":1473378786,"format":"standard","headTitle":"State of Health | KQED News","labelTerm":{"site":"stateofhealth"},"content":"\u003cp>Almost half of all Americans take prescription painkillers, tranquilizers, stimulants or sedatives, according to results of a \u003ca href=\"http://www.samhsa.gov/data/sites/default/files/NSDUH-FFR2-2015/NSDUH-FFR2-2015.htm\">federal survey\u003c/a> released Thursday. The prevalent use of these drugs could help explain why millions of Americans end up misusing or abusing them.\u003c/p>\n\u003cp>Last year, for the first time, the government's National Survey on Drug Use decided to ask the people it interviewed about all uses of prescription medicines, not just inappropriate use. The survey found that 119 million Americans over the age of 12 took prescription psychotherapeutic drugs. That's 45 percent of the population.\u003c/p>\n\u003cp>Of those, about 19 million Americans didn't follow a prescription. Most misuse involved people who acquired the drugs from friends or family. More than a third had a prescription but took those drugs excessively. And about 5 percent bought drugs from a dealer or stranger.\u003c/p>\n\u003cp>All told, 16 percent of all prescription drug use was actually misuse, according to the report.\u003c/p>\n\u003cp>There's no question that these drugs help alleviate pain and suffering for millions of Americans. But it's also clear that the system encourages overuse.\u003c/p>\n\u003cp>[ad fullwidth]\u003c/p>\n\u003cp>\"Any of us go to the doctor and feel like we don't get our money's worth if we don't come out with a prescription, right?\" Kim Johnson told Shots. She is director of the Center for Substance Abuse Treatment at the federal \u003ca href=\"http://www.samhsa.gov/\">Substance Abuse and Mental Health Services Administration\u003c/a>.\u003c/p>\n\u003cp>\"Just like any drug, the more it's out there, the more it's available, the more likely it is to be abused,\" she said. And many of these drugs pose an additional risk because of their physical effects, including in some cases their addictive properties.\u003c/p>\n\u003cp>The Centers for Disease Control and Prevention is trying to \u003ca href=\"https://www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf\">reform prescribing practices\u003c/a>, particularly for opioid drugs, to reduce the overuse of these pain medications. The new survey also documents the dire need for affordable and accessible treatment options.\u003c/p>\n\u003cp>\"One in 12 people aged 12 or over needed treatment for substance use disorder, yet nearly 90 percent of those people didn't get specialty treatment that could have helped them toward recovery,\" said Kana Enomoto, SAMHSA's principal deputy administrator, at a news conference.\u003c/p>\n\u003cp>That need for treatment pertains not just to prescription drug abuse but to street drugs such as heroin.\u003c/p>\n\u003cp>\"We need to expand access to treatment and we need to do it now,\" said Michael Botticelli, director of the White House \u003ca href=\"https://www.whitehouse.gov/ondcp\">Office of National Drug Control Policy\u003c/a>. \"Because, like every other disease, people who want treatment should be able to get it. And it should not be dependent on where they live or how much money they have.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>President Obama's budget for fiscal year 2017 called for more than $1 billion to expand access to drug treatment, but Congress has not acted on it.\u003c/p>\n\n","blocks":[],"excerpt":"There's no question that these drugs help alleviate pain and suffering for millions of Americans. But it's also clear that the system encourages overuse.\r\n","status":"publish","parent":0,"modified":1473378842,"stats":{"hasAudio":false,"hasVideo":false,"hasChartOrMap":false,"iframeSrcs":[],"hasGoogleForm":false,"hasGallery":false,"hasHearkenModule":false,"hasPolis":false,"paragraphCount":14,"wordCount":470},"headData":{"title":"Half of Americans Take Prescription Drugs That Could Lead to Addiction | KQED","description":"There's no question that these drugs help alleviate pain and suffering for millions of Americans. But it's also clear that the system encourages overuse.\r\n","ogTitle":"","ogDescription":"","ogImgId":"","twTitle":"","twDescription":"","twImgId":""},"disqusIdentifier":"234838 http://ww2.kqed.org/stateofhealth/?p=234838","disqusUrl":"https://ww2.kqed.org/stateofhealth/2016/09/08/half-of-americans-take-prescription-drugs-that-could-lead-to-addiction/","disqusTitle":"Half of Americans Take Prescription Drugs That Could Lead to Addiction","customPermalink":"2016/09/08/234838/","nprByline":"Richard Harris \u003cbr />\u003ca href=\"http://www.npr.org/sections/health-shots/\">NPR Shots\u003c/a>","path":"/stateofhealth/234838/half-of-americans-take-prescription-drugs-that-could-lead-to-addiction","audioTrackLength":null,"parsedContent":[{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003cp>Almost half of all Americans take prescription painkillers, tranquilizers, stimulants or sedatives, according to results of a \u003ca href=\"http://www.samhsa.gov/data/sites/default/files/NSDUH-FFR2-2015/NSDUH-FFR2-2015.htm\">federal survey\u003c/a> released Thursday. The prevalent use of these drugs could help explain why millions of Americans end up misusing or abusing them.\u003c/p>\n\u003cp>Last year, for the first time, the government's National Survey on Drug Use decided to ask the people it interviewed about all uses of prescription medicines, not just inappropriate use. The survey found that 119 million Americans over the age of 12 took prescription psychotherapeutic drugs. That's 45 percent of the population.\u003c/p>\n\u003cp>Of those, about 19 million Americans didn't follow a prescription. Most misuse involved people who acquired the drugs from friends or family. More than a third had a prescription but took those drugs excessively. And about 5 percent bought drugs from a dealer or stranger.\u003c/p>\n\u003cp>All told, 16 percent of all prescription drug use was actually misuse, according to the report.\u003c/p>\n\u003cp>There's no question that these drugs help alleviate pain and suffering for millions of Americans. But it's also clear that the system encourages overuse.\u003c/p>\n\u003cp>\u003c/p>\u003c/div>","attributes":{"named":{},"numeric":[]}},{"type":"component","content":"","name":"ad","attributes":{"named":{"label":"fullwidth"},"numeric":["fullwidth"]}},{"type":"contentString","content":"\u003cdiv class=\"post-body\">\u003cp>\u003c/p>\n\u003cp>\"Any of us go to the doctor and feel like we don't get our money's worth if we don't come out with a prescription, right?\" Kim Johnson told Shots. She is director of the Center for Substance Abuse Treatment at the federal \u003ca href=\"http://www.samhsa.gov/\">Substance Abuse and Mental Health Services Administration\u003c/a>.\u003c/p>\n\u003cp>\"Just like any drug, the more it's out there, the more it's available, the more likely it is to be abused,\" she said. And many of these drugs pose an additional risk because of their physical effects, including in some cases their addictive properties.\u003c/p>\n\u003cp>The Centers for Disease Control and Prevention is trying to \u003ca href=\"https://www.cdc.gov/media/modules/dpk/2016/dpk-pod/rr6501e1er-ebook.pdf\">reform prescribing practices\u003c/a>, particularly for opioid drugs, to reduce the overuse of these pain medications. The new survey also documents the dire need for affordable and accessible treatment options.\u003c/p>\n\u003cp>\"One in 12 people aged 12 or over needed treatment for substance use disorder, yet nearly 90 percent of those people didn't get specialty treatment that could have helped them toward recovery,\" said Kana Enomoto, SAMHSA's principal deputy administrator, at a news conference.\u003c/p>\n\u003cp>That need for treatment pertains not just to prescription drug abuse but to street drugs such as heroin.\u003c/p>\n\u003cp>\"We need to expand access to treatment and we need to do it now,\" said Michael Botticelli, director of the White House \u003ca href=\"https://www.whitehouse.gov/ondcp\">Office of National Drug Control Policy\u003c/a>. \"Because, like every other disease, people who want treatment should be able to get it. And it should not be dependent on where they live or how much money they have.\"\u003c/p>\n\u003cp>\u003c/p>\n\u003cp>President Obama's budget for fiscal year 2017 called for more than $1 billion to expand access to drug treatment, but Congress has not acted on it.\u003c/p>\n\n\u003c/div>\u003c/p>","attributes":{"named":{},"numeric":[]}}],"link":"/stateofhealth/234838/half-of-americans-take-prescription-drugs-that-could-lead-to-addiction","authors":["byline_stateofhealth_234838"],"categories":["stateofhealth_2746"],"tags":["stateofhealth_643","stateofhealth_2808","stateofhealth_2519","stateofhealth_2888","stateofhealth_2525","stateofhealth_2891","stateofhealth_2890","stateofhealth_2889"],"featImg":"stateofhealth_234857","label":"stateofhealth"}},"programsReducer":{"possible":{"id":"possible","title":"Possible","info":"Possible is hosted by entrepreneur Reid Hoffman and writer Aria Finger. 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You ask the questions. You decide what Bay Curious investigates. And you join us on the journey to find the answers.","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Bay-Curious-Podcast-Tile-703x703-1.jpg","imageAlt":"\"KQED Bay Curious","officialWebsiteLink":"/news/series/baycurious","meta":{"site":"news","source":"kqed","order":"4"},"link":"/podcasts/baycurious","subscribe":{"apple":"https://podcasts.apple.com/us/podcast/bay-curious/id1172473406","npr":"https://www.npr.org/podcasts/500557090/bay-curious","rss":"https://ww2.kqed.org/news/category/bay-curious-podcast/feed/podcast","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93dzIua3FlZC5vcmcvbmV3cy9jYXRlZ29yeS9iYXktY3VyaW91cy1wb2RjYXN0L2ZlZWQvcG9kY2FzdA","stitcher":"https://www.stitcher.com/podcast/kqed/bay-curious","spotify":"https://open.spotify.com/show/6O76IdmhixfijmhTZLIJ8k"}},"bbc-world-service":{"id":"bbc-world-service","title":"BBC World Service","info":"The day's top stories from BBC News compiled twice daily in the week, once at weekends.","airtime":"MON-FRI 9pm-10pm, TUE-FRI 1am-2am","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/BBC-World-Service-Podcast-Tile-360x360-1.jpg","officialWebsiteLink":"https://www.bbc.co.uk/sounds/play/live:bbc_world_service","meta":{"site":"news","source":"BBC World Service"},"link":"/radio/program/bbc-world-service","subscribe":{"apple":"https://itunes.apple.com/us/podcast/global-news-podcast/id135067274?mt=2","tuneIn":"https://tunein.com/radio/BBC-World-Service-p455581/","rss":"https://podcasts.files.bbci.co.uk/p02nq0gn.rss"}},"code-switch-life-kit":{"id":"code-switch-life-kit","title":"Code Switch / Life Kit","info":"\u003cem>Code Switch\u003c/em>, which listeners will hear in the first part of the hour, has fearless and much-needed conversations about race. Hosted by journalists of color, the show tackles the subject of race head-on, exploring how it impacts every part of society — from politics and pop culture to history, sports and more.\u003cbr />\u003cbr />\u003cem>Life Kit\u003c/em>, which will be in the second part of the hour, guides you through spaces and feelings no one prepares you for — from finances to mental health, from workplace microaggressions to imposter syndrome, from relationships to parenting. The show features experts with real world experience and shares their knowledge. Because everyone needs a little help being human.\u003cbr />\u003cbr />\u003ca href=\"https://www.npr.org/podcasts/510312/codeswitch\">\u003cem>Code Switch\u003c/em> offical site and podcast\u003c/a>\u003cbr />\u003ca href=\"https://www.npr.org/lifekit\">\u003cem>Life Kit\u003c/em> offical site and podcast\u003c/a>\u003cbr />","airtime":"SUN 9pm-10pm","imageSrc":"https://cdn.kqed.org/wp-content/uploads/2024/04/Code-Switch-Life-Kit-Podcast-Tile-360x360-1.jpg","meta":{"site":"radio","source":"npr"},"link":"/radio/program/code-switch-life-kit","subscribe":{"apple":"https://podcasts.apple.com/podcast/1112190608?mt=2&at=11l79Y&ct=nprdirectory","google":"https://podcasts.google.com/feed/aHR0cHM6Ly93d3cubnByLm9yZy9yc3MvcG9kY2FzdC5waHA_aWQ9NTEwMzEy","spotify":"https://open.spotify.com/show/3bExJ9JQpkwNhoHvaIIuyV","rss":"https://feeds.npr.org/510312/podcast.xml"}},"commonwealth-club":{"id":"commonwealth-club","title":"Commonwealth Club of California Podcast","info":"The Commonwealth Club of California is the nation's oldest and largest public affairs forum. 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