The FDA is ramping up its examination of safety concerns surrounding the use of cough syrups containing codeine for children under the age of 12. An announcement posted on the regulatory agency’s website on Wednesday highlighted its concerns:

“We are evaluating all available information and will also consult with external experts by convening an advisory committee to discuss these safety issues.”

It is not the first time the FDA has come out against the use of codeine products by children. In 2013, it issued a warning against prescribing the drug after surgery to remove tonsils in children. Wednesday’s announcement urged parents, or the primary caregiver, to watch for signs of adverse reactions to codeine.

“Parents and caregivers who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child should stop giving their child codeine and seek medical attention immediately by taking their child to the emergency room or calling 911.”

Unfortunately, some doctors are not heeding the warning. In a study published last year, 870,000 prescriptions for codeine cough syrup were written every year for children of all ages. The most likely to obtain a prescription are kids aged eight to twelve.

The problem with codeine and children is some cannot metabolize the drug and need higher doses. Others metabolize it too quickly. Both scenarios can lead to accidental overdoses and land kids in the ER.

What is Codeine

Codeine is an opioid analgesic or pain relief medication. It is often combined with other medications such as cough and other cold medications. If you’ve ever had a case of severe bronchitis or a cough that keeps you up at night, you’ve probably been prescribed codeine cough syrup.

Other opioid medications that are combined into cough syrups include hydrocodone. You’ll know if you’ve been prescribed the medication. Those sleepless nights of coughing up a lung are replaced with a drug-induced haze. It beats coughing, but not something you want to be sipping on regularly.

The American Academy of Pediatrics has warned against the prescribing codeine to children since 1997.

The move by the FDA is in the wake of an April announcement by the European Medicines Agency. Its committee ruled these types of medications “must not be used to treat cough and cold in children under 12 years.”

It further recommended the class of medications not be prescribed to children between the ages of 12 and 18. The agency cited side effects such as “slowed or difficulty breathing” as the chief reason for the recommendation.

For parents, exhaust every other option first. There are breathing treatments and other cough medications to run through before turning to opioid-based medications to treat severe coughs.


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