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We're nonprofit - we don't take $$ from pharmaceutical, health insurance companies or medical device makers. The expert panel focused on the risk of serious side effects or adverse events, such as respiratory depression and death. Children are often prescribed codeine for pain relief after surgery to remove their tonsils or adenoids.
But in the past decade, the FDA has been looking into its safety for children following reports of the potential for serious adverse effects, including slowed or difficult breathing.
The Drug Enforcement Administration (DEA) classifies codeine as a schedule II drug, meaning it has a high potential for abuse, which may lead to severe psychological or physical dependence. Prescription and OTC drugs are, after marijuana and alcohol, the most commonly abused substances by Americans 14 and older, according to The National Institute on Drug Abuse (NIDA), a branch of the National Institutes of Health, U.S. While we wait for the FDA to decide whether to restrict OTC sales of codeine products, the federal agency advises that “parents and caregivers should watch children receiving codeine for pain closely for signs of morphine overdose.
Talk to your child’s healthcare provider if you have any questions or concerns about codeine.


Sarah Smedley has 20 years’ experience in communications for the medical, pharmaceutical, biotech, consumer health, fitness, philanthropy and nutrition industries. Report Side EffectsIf you've had a side effect from a drug or a medical device, Let the FDA know. This site complies with the HONcode standard for trustworthy health information: verify here. The committee met in December 2015 to discuss the safety of codeine-containing drugs (codeine is an opioid pain reliever, also known as a narcotic) for children 18 and younger.
The December 2015 expert panel almost unanimously advised that drugs containing codeine should not be used to treat children or the majority of teens suffering from pain or a cough. Constance Houck, an anesthesiologist at Boston Children’s Hospital, speaking on behalf of the AAP. Edward Markey (D-MA) put a hold on the nomination of Robert Califf, MD, to be commissioner of FDA until the agency makes reforms to its approval process for opioid analgesics, according to The Hill. There are a number of symptoms to watch for, says Bob Rappaport, MD, director of the Division of Anesthesia, Analgesia and Addiction Products (DAAAP) in FDA’s Center for Drug Evaluation and Research.


If it’s decided that the benefit of prescribing products that contain codeine to outweighs the risk, FDA is advising that the lowest effective dose be prescribed for the shortest period of time.
She is now a freelance writer and frequent contributor to The BROADSHEET, a daily online and bi-weekly print newspaper.
MedShadow does not accept advertising or contributions from pharmaceutical companies, health insurance companies, medical device manufacturers or political action organizations. These products (Tylenol with codeine, Capital with codeine, Codrix, Proval and other brands) are available for use by children as young as 2. Markey is unhappy with FDA’s 2015 decision to approve the use of oxycodone hydrochloride (OxyContin) to treat children as young as 11. That doesn’t bode well for future decisions about the use of this class of drugs for kids.




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