Children who are given codeine for pain relief after surgery to remove
tonsils or adenoids are at risk for overdose and death, US health officials
The US Food and Drug Administration said a new boxed warning - the agency's
strongest caution - will be added to the labels of codeine-containing products
to warn about this danger.
The FDA strongly recommends against the use of codeine to manage pain in
children after surgery to remove tonsils or adenoids, and suggests that doctors
use an alternate pain reliever. The agency also said parents and caregivers need
to be aware of the risks and ask for a different pain medicine if their children
are prescribed codeine after having their tonsils or adenoids removed.
Codeine is an opioid (narcotic) medication used to treat mild to moderate
pain and is often prescribed to children after tonsil or adenoid removal.
However, some children have died after being given codeine within the
recommended dose range.
In August 2012, the FDA warned about the danger in children who are
"ultra-rapid metabolisers" of codeine, which means their liver converts codeine
to morphine in higher-than-normal amounts. High levels of morphine can result in
potentially fatal breathing problems.
Be aware of the signs
Since then, a safety review by the FDA identified 10 deaths and three
overdoses associated with codeine that occurred among children in the United
States between 1969 and May 2012. Many of these children were recovering from
surgery to remove tonsils or adenoids.
All of the children, aged 21 months to 9 years old, received doses of codeine
within the normal dose range. Signs of morphine overdose developed within one to
two days after the children began taking codeine, the FDA said in an agency news
Codeine is available by prescription either alone or in combination with
acetaminophen and aspirin, and in some cough and cold medications.
When prescribed to treat pain, codeine should not be given on a fixed
schedule, but only when a child needs relief from pain. They should never
receive more than six doses in a day, the FDA said.
Children receiving codeine for pain should be closely monitored for signs of
morphine overdose. These include: unusual sleepiness, such as being difficult to
wake up; confusion or disorientation; breathing problems; and blueness on the
lips or around the mouth.
Parents and caregivers who notice such signs should stop giving codeine and
immediately take the child to an emergency department or call 911, said Dr Bob
Rappaport, director of the division of anaesthesia, analgesia and addiction
products in FDA's Center for Drug Evaluation and Research.
The US National Library of Medicine has more about codeine.