April 24, 2017
The FDA has issued a Safety Alert restricting the use of codeine and tramadol in children. Children under 12 years and some adolescents younger than 18 years (especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems) should not use medicines containing these drugs because of increased medical risks, including slowed or difficult breathing and death. The FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants, including excess sleepiness, serious breathing problems, or death.
