FDA Updates Labeling for Opioid-Containing Medications to Limit Use in Children

FDA Updates Labeling for Opioid-Containing Medications to Limit Use in Children

According to a statement from the agency, the safety labeling changes are meant to limit the use of these medications in children younger than 18 years old, as these products could be associated with risks.

Common adverse effects of opioid therapies include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache, according to the FDA. Greater dangers include breathing difficulties and even death.

Furthermore, labeling for these products will now include an expanded Boxed Warning, explaining "the risks of misuse, abuse, addiction, overdose and death, and slowed or hard breathing" that can result - even in adults. 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. At the time, officials expressed concerns that some children are "ultrarapid metabolizers" who process such drugs very quickly, resulting in dangerously high levels that can depress breathing and lead to death. For those children in whom cough treatment is necessary, alternative medicines are available. The panel declared that the risks of using certain opioids in children's cough medications outweigh the benefits.

Citing the risks to patients younger than 18 years old, the FDA is requiring labeling changes to prescription cough and cold medications that contain codeine or hydrocodone.

"Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated".

The agency urged parents to read the labels on prescription bottles. "It's become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don't justify their use in this vulnerable population".

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