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FDA Issues New Label Change for Codeine and Tramadol

Writer's picture: Sanjay TrivediSanjay Trivedi

The FDA is now warning against the use of codeine and tramadol in children under the age of 12. The warning is due to a higher incidence of slowed or difficult breathing and death in children.

The new labeling for products containing codeine adds a warning that they should not be used to treat cough in children under 12. Labeling for tramadol states that it should not be used to treat pain in children under 12 or used in children under 18 to treat pain after a tonsillectomy and/or adenoidectomy.

The FDA is also adding a warning recommending against the use of these drugs in children between 12 and 18 who have conditions such as obstructive sleep apnea or severe lung disease, because of the increased risk of severe breathing problem. Finally, the labels also include a strengthened warning to mothers that breastfeeding is not recommended when taking either codeine or tramadol, as this can cause serious adverse reactions in their babies or toddlers.

(Reference: http://drugtopics.modernmedicine.com/node/435048)

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