FDA Restricts Use Of Codeine,Tramadol; Requires Labeling Changes

FDA is restricting the use of codeine and tramadol medicines in children and requiring label changes of all prescription medicines containing these drugs, which are used to treat pain, the agency announced Thursday (April 20). Changes include adding the agency's strongest warning -- a contraindication -- to the drug labels, a strengthened warning to mothers who are breastfeeding and a new warning to recommend against the use of the drugs in adolescents between 12 and 18 years old who are...