There is a new FDA (Federal Drug Administration) warning for two drugs codeine and tramadol. This warning is for children and nursing mothers.
Children who are younger than 12 should not be given these drugs at all. Infants can be exposed through breast milk. These drugs should be used with care in children who are 12 years or older.
Things to Know:
- ONLY adults should use codeine or tramadol.
- ALWAYS check medicine labels for these drugs.
- ASK your doctor to check the label with you if you're not sure.
- DO NOT use codeine or tramadol if you or your child has the CYP2D6 gene. This is known as a "ultra-rapid metabolizer." This means the body breaks down these drugs faster, before they have had a chance to work.
- WATCH children of any age who might be taking these drugs for signs of breathing problems.
Signs of Breathing Problems in Children or Nursing Infants:
- Slow or shallow breathing
- Trouble or noisy breathing
- More tired than normal
- Trouble nursing
If you notice any of these signs, get urgent care or call 9-1-1.
Drug Label Changes
The FDA gives these drugs their strongest label warning. You will see this label on medicine that has one of these drugs in them.
Codeine should not be used to treat pain or cough in children who are younger than 12.
Tramadol should not be used to treat pain in children who are younger than 12.
Children who are between 12 and 18 years old should not get tramadol after surgery to remove their tonsils or adenoids. They also should not use tramadol if they are at risk for breathing problems, like being overweight or if they have a lung disease.
Again, mothers should not breastfeed when using codeine or tramadol. Infants can be exposed to these drugs through breast milk.
- Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women. U.S. FDA Website. https://www.fda.gov/. Accessed 2017/4/20.