FDA Pulls Pediatric Indications For Opioid Cough And Cold Medicines

Bottles of NyQuil left Tylenol center front and Theraflu right all containing acetaminophen appear together in Walpole Mass. Tuesday

The new label's safety warnings will be consistent with the labeling of other opioid-containing drug products, such as immediate-release opioid analgesics and extended-release and long-acting opioid analgesics.

Additionally, labels will also include updated safety information for use in adults, including an expanded boxed warning notifying about the risks of misuse, abuse, addiction, overdose, death, and slow or hard breathing that can result from exposure. As the age range has been changed for prescription opioid cough/cold products with this action, the FDA is recommending that healthcare professionals provide alternative treatments for children (ie, dextromethorphan, prescription benzonatate) when treatment of cough is necessary.

Common adverse effects of opioid therapies include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache, according to the FDA.

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The US Food and Drug Administration (FDA) has announced safety labeling changes that will limit the availability of prescription opioid cough and cold medicines for patients younger than 18 years old. Notably, the FDA advisory committees that have been responsible for assessing the suitability of utilizing opioids as treatment options for coughs and colds in pediatric populations have focused on two age groups: those 6 to 12, and those 12 to 18.

The label changes, which will pertain to medicines containing codeine or hydrocodone, will also include safety information for adult use.

The move comes after a 2017 decision by the FDA to add its strongest warning - a "contraindication" - to labeling for prescription products containing codeine. "We know that some children and teens may, in fact, develop a predilection for the "high" the prescription cough syrups deliver, and subsequently attempt to deceive parents and health care providers regarding the severity of their symptoms to obtain such a prescription". Experts say parents should always read labels before giving their children any medicine, even if it's purchased over the counter.

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