FDA steps up its restrictions of opioids
Friday, January 19, 2018
As the opioid crisis continues to ravage the United States, government officials at both the state and federal level have been seeking to implement measures that curtail the growth of an epidemic that led to 34,500 overdose deaths in 2016. To date, the opioid epidemic is considered to be one of America's deadliest crises, even when compared to the number of car crash deaths in 1972, gun violence deaths in 1993 and HIV/AIDS deaths in 1995.
The impact that is felt by the crisis can be observed across different people from various walks of life. One area of the opioid crisis that has not been widely discussed or garnered much attention until recently is children's cough and cold medications containing opioids.
The use of opioid-containing drug products in this patient population is one that requires a thorough evaluation of the risks versus the benefits prior to the initiation of therapy. The potential risk for misuse, abuse, addiction, potential overdose or even death is one that both healthcare professionals and the general public should be made aware.
Given the vulnerability of the pediatric population, the Food and Drug Administration (FDA) recently issued new restrictions to labeling, stating that opioid-containing cough and cold medications "will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older."
FDA Commissioner Scott Gottlieb, M.D., said the concern for exposing children unnecessarily to opioids is one of the reasons for the decision.
"Given the epidemic of opioid addiction, we're concerned about unnecessary exposure to opioids, especially in young children," Gottlieb said. "We know that any exposure to opioid drugs can lead to future addiction. 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."
The intent of this new adults-only labeling — as well as labeling that warns about the potential for overdose and death — is to ensure that measures are in place for assessing the use of opioid-containing drug products. The FDA's stance aims to limit the use of opioid-containing cough and cold products in this population, and it is one of many of the steps that are being taken to address this serious epidemic that continues to impact many Americans.
“It's critical that we protect children from unnecessary exposure to prescription cough medicines containing codeine or hydrocodone," Gottlieb said. "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."
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