The FDA on Thursday said it will require a safety label change for cough and cold treatments containing codeine or hydrocodone to indicate these medications are no longer safe for use in children. The decision to change the labeling was made in response to the fact that the "serious risks of these medicines outweigh their potential benefits in this population", said the announcement from the FDA.
Gottlieb also cited the ongoing epidemic of opioid addiction, and stressed the importance of reducing exposure to addictive drugs at a young age.
The FDA also said it is requiring manufacturers to add new safety warnings for adult use - including an expanded box warning, the most prominent kind - spelling out the risks of using medications with codeine and hydrocodone. Cold and cough medicines that contain either codeine or hydrocodone will also have to have the same labels as any other medicine that contains an opioid.
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They go much further than the 2017 labeling rules - restricting use of codeine-containing products to everyone under the age of 18, and including cough-and-cold products that contain a second drug, the opioid oxycodone. A year ago the restrictions were expanded to include safety labels that carried the contraindication warning, the FDA's most severe warning, to say that it should not be used for patients under the age of 12. The FDA advises against giving any over-the-counter cold, flu and cough remedies to children under 2, and the Infectious Diseases Society of America says don't give them to children under 4.
Parents whose children are now prescribed a cough and cold medicine containing codeine or hydrocodone are encouraged to talk to their child's health care professional about other treatment options, the FDA advised. According to FDA, "After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older".
The FDA pointed to known side effects of opioid medications, including "drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache".
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A strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. If a cough medicine is prescribed, ask your child's health care professional or a pharmacist if it contains an opioid such as codeine or hydrocodone. According to the FDA, they should talk to their child's doctor about alternative therapies. The FDA also held an expert roundtable and convened a meeting of its Pediatric Advisory Committee to look at all the risks associated with the use of codeine- or hydrocodone-containing cough and cold products in children and adolescents younger than 18-years-old.
"It is important for parents and caregivers to understand that a cough due to a common cold often does not need medicines for treatment".
There's more about this issue at the American Academy of Pediatrics.
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