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13:53 PM

FDA Restricts Use Of Prescription Pain and Cough Medicines In Children

Pain Management Pediatrician discusses use of codeine and tramadol among kids

The Food and Drug Administration (FDA) has announced restrictions on the use of codeine and tramadol medicines in children. The FDA states “these medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children.”

The FDA will require several changes to the labels of all prescription medicines containing these drugs:

  • 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.
  • A label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and and/or adenoids.
  • A recommendation against their use in adolescents between the ages of 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of serious breathing problems.
  • Breastfeeding mothers should not take codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. These can include excessive sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.

“Opioid abuse has become a public health concern and should be addressed as such. The more awareness we have for providers and families the better the communication can be amongst the community,” said Artee Gandhi, M.D., medical director of the Pain Management Clinic at Cook Children’s.

Dr. Gandhi said tramadol has generally been considered a “safe” drug. However, the physicians in the pain clinic recognize it as an opioid with the same risks as medications such as codeine. In addition to the physiologic effects, there are the psychological concerns of addiction and overdose.

“Early exposure to opioids also increases the risk of misuse and abuse even if prescribed for medical reasons,” Dr. Gandhi said. “Adolescents do not have the cognitive ability to appraise the situation and deem the consequences of prolonged exposure. If prescribed by a physician they must be safe. It is the duty of health care providers to educate patients and families on the correct use of these medications.”

For more information

Cook Children's Pain Management improves the quality of life for our pediatric patients by providing a balance between medicine and therapy.

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