The FDA has issued new warnings that children are not being adequately protected from the potentially fatal effects of the opioid crisis. Statistics show that although the majority of overdose cases in children are unintentional, 10% end in hospitalization and opioids are the cause death of 300 children every year in the US.
These figures are shocking. But what can be done to protect children from this ongoing public health issue? The new advice from the FDA is focused around the labeling of products. Some products aimed at children contain opioids like codeine and hydrococdone. The new recommendations are that these products should only be given to those over 18 and that even though they are designed to reduce pain, it’s now believed that the risks outweigh the benefits in the vast majority of cases.
The new and revised safety warnings on products aimed at children will be in line with other products containing opioids, like immediate-release opioid analgesics and extended-release and long-acting opioid analgesics. “Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction,” said FDA Commissioner Dr. Scott Gottlieb.
“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,” he said. “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 common cough and cold is possible without using opioid-containing products.”
These changes will require the current safety labeling on products to be altered to incorporate the new advice. Alongside this, the FDA plans to make changes across the industry, which would require additional warnings to be displayed on products aimed at adults, including warnings about the risk of addiction, the effects of misusing the products and the potential consequences – including death.
The previous guidelines were primarily focused on the safety of “high risk patients”. However, according to the CDC opioids are now considered a risk for all patients and that the tools currently being used to prevent abuse can’t be relied on to prevent harm to the public. The new recommendations aim to provide better care for all patients prescribed opioids to help bring down the levels of abuse we’re seeing.
The new guidelines from the FDA include both revising the safety labeling on prescription products and expands on the current restrictions on children’s products. All parents who have been given opioid medicines for their children are being advised to consult a health care professional, who should be able to provide an alternative treatment option if needed. The agency has also highlighted that some over the counter medications may contain codeine, and parents are being urged to check the labels of products before purchasing them.
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