An FDA advisory panel recommends that warnings on cough syrups be extended from young children to everyone under 18. ByWilliam McConnell. Sep 14, 2017 10:13 AM EDT. A senior Food and Drug Administration official said over-the-counter products should be added to the agency's limits on use of.
John Alexander, the FDA's deputy director for the division of pediatric and maternal health in the Office of Drug Evaluation in the Center for Drug Evaluation and Research made his comments during a meeting this week of an FDA advisory panel the was examining the next steps the agency should take in deal with the risks codeine-containing pediatric prescription drugs pose to children. At the meeting, held Monday, Sept. 11, the panel overwhelmingly urged the FDA to extend its warning against use of the products from anyone 12 and younger to anyone 18 and younger.
against their use in children 12 and younger, the requirement made good on a previous advisory panel recommendation made in 2015.
FDA panel says risk of opioid use in kids' cough medicines outweighs benefits. By Ike Swetlitz @ikeswetlitz. September 11, 2017 Seymour also noted that the FDA wanted to make sure that cough medicines containing codeine were available for older children who needed them, while keeping them away from children.
With increased public attention on prescription opioid abuse, the meeting was also cast as an attempt to think about the question of cough medicine in a new way, taking into account the broad public health implications of a world with more opioids.
Indeed, one committee member compared the question of the day to “Mrs. Winslow’s Soothing Syrup,” a 19th-century cough medicine, ridiculed as a “baby killer” in a 1911 American Medical Association publication, “Nostrums and Quackery.” The active ingredient in the syrup was morphine.
By Ike Swetlitz @ikeswetlitz September 11, 2017 R.
infectious disease pediatrics.
Public Release: 16-Nov-2017. Study shows codeine prescribed to children despite FDA warning against it. University of In 2013, the FDA issued a "black box warning" against the use of codeine following tonsillectomies and adenoidectomies in children, due to an increasing number of reported deaths in such instances.
The research from the University of Chicago Medicine, the University of Michigan and Harvard University was published Thursday in the journal Pediatrics. A new study shows as many as one in 20 children were still receiving codeine to treat pain after tonsil and adenoid surgery, two years after federal regulators warned doctors that prescribing the opioid to kids after the routine surgeries could be fatal.
In the future, the researchers believe quality improvement efforts should focus on eliminating all inappropriate codeine prescribing and encouraging the use of effective non-opioid medications like acetaminophen and ibuprofen.
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A federal committee will meet in three weeks to consider whether cough medicine containing certain opioids should be prescribed to children, the Food and Drug Administration announced Monday. The agency already warned in April that drugs containing codeine, which is an opiate, “should not be used.
At the time, the agency said that codeine, along with tramadol, an opioid found in some pain medications for children, “carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years.”
An FDA spokesperson declined to provide more information about specifically what the committee will discuss, but said that discussion questions will be made available online before the meeting.
FDA Commissioner Scott Gottlieb has made it a priority of his agency to reduce opioid abuse.
1. Pediatrics. 2017 Dec;140(6). pii: e . doi: 10.1542/peds. . Epub 2017 Nov 16. BACKGROUND: In August 2012, the Food and Drug Administration investigated the safety of codeine use by children after tonsillectomy and/or adenoidectomy, culminating in a black box warning in February 2013.
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The Food and Drug Administration investigation substantially decreased codeine prescribing to children after tonsillectomy and/or adenoidectomy. However, 1 in 20 children undergoing these surgeries were still prescribed codeine in December 2015 despite its well-documented safety and efficacy issues.
Using an interrupted time series design, we estimated level and slope changes in the proportion of children with ≥1 prescription fills for codeine and ≥1 fills for an alternative opioid, such as hydrocodone, within 7 days of surgery.