FDA Restricts Child Pain and Cough Meds
On April 20th, the U.S. Food and Drug Administration (FDA) issued a safety announcement restricting the use of codeine and tramadol in cough, cold, and pain medications for children and women who are breastfeeding. The new announcement updates previous guidelines for these medications issued in 2015.
According to the FDA, codeine—which is approved to treat pain and cough—and tramadol—which is approved to treat pain--carry serious risks, including breathing problems and death, especially in children. As a result, the FDA is making several changes to labels of prescription medications that contain codeine or tramadol.
The changes include warnings, as well as contraindications—the FDA’s strongest advisement—for parents and caregivers, patients, and health care providers. For more information, including a list of medications that contain codeine or tramadol, please see the FDA Drug Safety Communication.
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