FDA Investigating Off-Label Use Of Tramadol In Pediatric Patients

(September 30, 2015, 8:00 AM EDT) -- SILVER SPRING, Md. — The Food and Drug Administration on Sept. 21 said it is investigating the off-label use of the pain drug tramadol (brand name Ultram) in children under 17 years of age because of a rare but serious risk of slowed or difficult breathing.

The FDA says the risk may be increased when tramadol is given to children who have had their tonsils or adenoids removed.

The agency says tramadol is not approved for use in children, but data show it is being used...
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