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techkenyot.com January 23, 2018


Health Alert: FDA warns of opioids in cold medicines

13 January 2018, 04:05 | Silvia Roy

FDA warns against giving kids cough and cold medicines with codeine or hydrocodone

FDA revises labelling in prescription cough and cold products to protect children from opioids

On Thursday, the FDA announced it is requiring the changes in order to limit the number of children using prescription opioid cough medicines and cold medicines containing codeine and hydrocodone. Cough and cold medicines that have opioid ingredients, such as codeine or hydrocodone, should no longer be given to children of any age. Both of these determined the risks of slowed or hard breathing, misuse, abuse, addiction, overdose, and death with these medicines outweigh their benefits in patients younger than 18.

In September, the FDA met with the Pediatric Advisory Committee to determine the dangers associated with using opioids in children's cough medicine.

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"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children", said Scott Gottlieb, MD, FDA commissioner. We know that any exposure to opioid drugs can lead to future addiction. If the medicine prescribed for your child contains an opioid, talk to your child's health care professional about a different, non-opioid medicine, or if you have any questions or concerns. After a 2013 warning by the FDA not to give children codeine after tonsillectomy or adenoidectomy procedures, an American Academy of Pediatrics report in November 2017 found that about 5 percent of children were still being prescribed the drug. 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. This alerts people that codeine should not be used to treat pain or cough in children younger than 12 years due to a specific risk of ultra-rapid metabolism in certain patients.

The FDA also recommended against the use of these medications by women who are breastfeeding. Hydrocodone, also known as Vicodin, is a prescription opioid used to treat more severe pain, said the Centers for Disease Control. Previous year 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. Parents of children 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.

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The agency also noted that some products sold over-the-counter in a few states may contain codeine or may not be appropriate for young children, so it's important to check the labels.

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