Keywords: analgesics, Ultram, (PubMed Search)
Bottom line: Do not prescribe codeine or tramadol for cough or pain in children and breastfeeding moms.
A summary statement from the American Hospital Association (AHA) is posted below.
FDA RESTRICTS USE OF CODEINE AND TRAMADOL
MEDICINES IN CHILDREN, RECOMMENDS AGAINST USE IN BREASTFEEDING MOTHERS
The Food and Drug Administration (FDA) today announced that it is restricting the use of codeine and tramadol medicines in children, as well as recommending against using codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.
Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines also should be limited in some older children.
The FDA is requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond FDA's 2013 restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. The agency is now adding:
The FDA is urging health care professionals and patients to report side effects involving codeine-and tramadol-containing medicines to the FDA MedWatch program, through its online form.