The opioid addiction epidemic is a serious health concern in the United States. Deaths from drug overdoses reached a high of 63,600 in 2016, a 21% increase over the previous years and the most significant single-year jump ever. Roughly 42,000 of those overdose deaths were from opioids. Fentanyl, a potent opioid, is a big part of the overdose issue. In the years from 2013 to 2016, deaths from fentanyl have gone up, on average, a whopping 88% each year.
In an attempt to prevent more addiction issues the U.S. Food and Drug Administration announced that there would be significant labeling changes to cough and cold medications that contain codeine or hydrocodone. Any cold medication or cough elixir that includes these drugs will now be labeled only for use in adults over the age of 18. The FDA has taken this step to reduce exposure to opioids in children. Children who have upper respiratory illness or cough will no longer be prescribed any medication containing codeine or hydrocodone. The FDA stated that any benefits these medicines have are far outweighed by the risks of addiction and overdose.
Any cough or cold medication that contains an opioid will also carry additional safety information for adults to whom it is prescribed. This will include what the FDA classifies as an expanded Box Warning, which is the agency's most prominent and severe warning placed on drugs. The notice will let patients know about the risks of using the medication, the potential for misuse, addiction, abuse, overdose, difficulty breathing and even death. These are all risks the FDA associates with any exposure to medications that contain hydrocodone or codeine. The safety warnings on these cough and cold medications will now be almost the same as the labels used on pain medications containing opioids.
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In a statement released by the agency, FDA Commissioner Scott Gottlieb, M.D 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. 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. 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."
The changes came about after the agency reviewed data with pediatric health experts. Last year, the labels on medicines containing any form of codeine were changed to reflect that the use of codeine was contraindicated—the FDA's most robust language on medication risk—in children under 12 years of age. There was a concern for addiction, but also that in some young patients, the drug is rapidly metabolized and this could increase the risk for overdosing accidentally. In 2013, the agency issued a "black box warning" which is their highest category of warning statement, advising against the use of codeine for pain relief in children under 12 who underwent tonsillectomy or adenoidectomy. The video below contains additional information.