Codeine gets FDA Black Box Warning
The U.S. Food and Drug Administration (FDA) is requiring all codeine products carry a black box warning about fatal risks associated with administering the drug to children after certain surgical procedures.
“Deaths have occurred post-operatively in children with obstructive sleep apnea who received codeine for pain relief following a tonsillectomy and/or adenoidectomy,” FDA Drug Safety Communication.
The FDA first warned of this issue back in August of 2012 in a Drug Safety Communication released to the public.
Codeine and Children
- Codeine is an opioid pain reliever which is converted to morphine by the liver.
- Some children are “ultra-rapid metabolizers of codeine.”
- This can cause the liver to convert codeine into life-threatening amounts of morphine in the body.
- This can lead to fatal morphine overdose in children.
- The FDA said 1.7 million prescriptions were written for codeine-containing medicines for children in 2011.
13 Child Deaths Reported
- The FDA has received reports of 13 deaths of children who were given codeine-containing drugs after surgery.
- Most deaths were found to take place after tonsil and adenoid removal surgeries.
- Many of the children who died had sleep apnea.
Signs of Codeine Overdose
Information below provided by the FDA.
- Signs of serious side effects of codeine in children can include unusual sleepiness, confusion, and difficult or noisy breathing.
- If your child shows these signs, stop giving your child codeine and seek medical attention immediately by taking your child to the emergency room or calling 911.
- Report side effects from codeine to the FDA MedWatch program.
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