FDA Making Clear Opioids Not Intended for Children

While it may have seemed like an obvious step to take, the most recent efforts by the FDA are important to changing the tone around the danger of opioids. CNN reported that on January 11, 2018, the Food and Drug Administration’s announced that cough and cold medicines with opioid ingredients, such as codeine or hydrocodone would have their labels revised. The labels will now address warnings that regardless of age, no child should be given these types of medications. Due to the ever-increasing opioid epidemic, the FDA explained that it is too risky for children to use these products and should only be prescribed to adults 18 years of age or older.

FDA Commissioner Dr. Scott Gottlieb explained: “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.”

According to the FDA, these safety warnings will stay consistent with other labels of products that contain opioid ingredients. They will contain similar statements like those on immediate-release opioid analgesics and extended-release and long-acting opioid analgesics. Addressing all safety concerns specifically for adults, the warning explains the risks associated with opioids such as misuse, abuse, addiction, overdose, even death.

This is not the first time the FDA has pushed for the discontinuing of prescribing drugs containing opioids to children. In 2013, what is considered to be the strongest statement of safety, a “black box warning,” was implemented to stop the prescribing of the opioid, codeine, to children for pain from tonsils or adenoids removal.

Although the warning was successful and the use of codeine for children decreased significantly, a study concluded that one in 20 kids were still being prescribed codeine at the end of 2015. That same year, the FDA also began investigating the side effects and risks for children under the age of 18 using medicine with codeine for coughs and colds.

In April of 2017, the FDA warned that opioids, codeine and tramadol could cause life-threatening breathing problems. Labeling was revised restricting the use by children younger than 12. Women who were currently breastfeeding were also advised not to use it.

With the newest action by the FDA, parents whose children are already using opioid containing cough and cold medicine should speak to their doctor about other treatment options. The FDA also addressed that some states selling over-the-counter products may contain codeine and may be risky for children.

“It’s become clear that 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,” said Gottlieb. “It’s critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone,” he added. Gottlieb explains that the actions being put into place are to help parents understand why it’s so crucial to discontinue any use of opioid containing products for treating their child’s common cold or cough.

Any type of opioid use shouldn’t be taken lightly. The FDA warns that regardless of age, everyone should be checking the labels of prescriptions and understand that these warnings are put into place for important reasons. If you are interested in finding out more about legal claims associated with harm resulting from opioid prescriptions for children or other opioid damages information, contact Stern Law, PLLC, at 844-808-7529.

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