FDA Orders Label Changes to Opioid-Containing Cold Medications to Protect Kids
The Food and Drug Administration (FDA) has issued an order directing the makers of cough and cold medications containing opioids such as hydrocodone and codeine to change their labels to restrict the use of those products for children younger than 18. The FDA is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population.
FDA Commissioner Scott Gottlieb, M.D., stated, given the epidemic of opioid addition, the FDA is concerned about unnecessary exposure to opioids, especially in young children. Any exposure to opioid containing medications can lead to future addiction. Children are at a particular risk in using these products due to their ability to rapidly metabolize the drugs, which concentrates the drugs affects. “It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone. At the same time we’re taking steps to help reassure parents that treating the commons is possible without using opioid-containing products”, said Gottlieb.
The FDA is also requiring labeling for the medications to be updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying users about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.
Parents of children currently prescribed a cough and cold medicine containing codeine or hydrocodone are encouraged to talk to their pharmacist or doctor before taking any medication. Caregivers should also read all labels on all medications and over-the-counter products to check for codeine and hydrocodone. Common side effects of opioids include drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache.
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