Manufacture and sale of children’s cough medicine containing opioid extracts have been declared illegal by the U.S. Food and Drug Administration (FDA).
In a press release on Thursday, the agency said its newest regulations aimed at curbing America’s skyrocketing opioid addiction will offer protection for kids by ensuring that all opioid-containing cold and cough products for persons under 18 are banned.
“This decision is based on an extensive review of available data and expert advice,” the agency said.
In its official statement, the FDA said: “After safety labeling changes are made, these products 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.”
According to the press release, another prescription medicine affected by the new regulations is codeine or oxycodone.
The FDA updated Boxed Warning tells adult users to consider the negative consequences or risks of “misuse, abuse, addiction, and overdose,” which ranges from slowed to difficult breathing and death. These may occur as a result of exposure to codeine or hydrocodone, the agency added.
In support of this leap in the fight against the opioid epidemic, Dr. Scott Gottlieb (FDA Commissioner) said: “Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children.”
He continued, “We know that any exposure to opioid drugs can lead to future addiction.
“It has 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 is very important that we desist from using such products in order to protect children. This unnecessary exposure to prescription cough medicines containing codeine or hydrocodone could lead to fatal problems in the future.
“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,” he added.
This latest “CONTRAINDICATION” warning from the FDA goes contrary to its 2017 rating for the same opioid-containing products.
As of last year, only children aged 12 and above are allowed prescription medicines containing codeine “due to a specific risk of ultra-rapid metabolism in certain patients,” the agency explained.
However, the recent regulations state that everyone under 18 must have restricted access to codeine-containing products, including cough-and-cold products that contain a second drug it identified as opioid oxycodone.
“In any case, there’s little that can or should be done to ease most children’s cough and colds,” the FDA said, quoting some “expert advice as indicating that although some pediatric cough symptoms do require treatment, cough due to a cold or upper respiratory infection typically does not require treatment.
“Moreover, the risks of using prescription opioid cough products in children of all ages generally outweigh the potential benefits.”
Some of the proven side effects of opioid medicines listed by the FDA are: drowsiness, dizziness, nausea, vomiting, constipation, shortness of breath and headache.
