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FDA Issues New Warnings About Use of Codeine and Tramadol in Children and Nursing Mothers

Agency adds restrictions to product labels

The FDA is restricting the use of codeine and tramadol medications in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. These drugs carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and the drugs should not be used in these children, according to the agency. These medications should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults.

The FDA is also recommending against the use of codeine and tramadol medications in breastfeeding mothers because of possible harm to their infants.

The agency has made several changes to the labels of all prescription medications containing codeine or tramadol. These new actions further limit the use of these drugs beyond the FDA’s 2013 restriction of codeine use in children younger than 18 years of age to treat pain after surgery to remove the tonsils and/or adenoids.

The agency is now adding:

  • A contraindication to the drug labels of codeine and tramadol alerting that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12 years of age.
  • A new contraindication to the tramadol label warning against its use in children younger than 18 years of age to treat pain after surgery to remove the tonsils and/or adenoids.
  • A new warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years of age who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
  • A strengthened warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medications because of the risk of serious adverse events in breastfed infants. These events can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.

The FDA advises health care professionals to be aware that tramadol and single-ingredient codeine medications are agency-approved only for use in adults. Practitioners should consider recommending over-the-counter (OTC) or other FDA-approved prescription medications for cough and pain management in children younger than 12 years of age and in adolescents younger than 18 years of age, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems. Cough is often secondary to infection, is not serious, and usually will get better on its own, so treatment may not be necessary, the FDA adds.

The agency is considering additional regulatory action for OTC codeine products that are available in some states. OTC codeine products are available in combination with other medications for cough and cold symptoms. The FDA is also considering an advisory committee meeting to discuss the role of prescription opioid cough-and-cold medications, including codeine, to treat cough in children.

Source: FDA; April 20, 2017.

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