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Medication Safety Alerts

Codeine and Tramadol Medicines MedWatch

4/20/2017

On April 20, 2017, theUnited States Food and Drug Administration (FDA) issued a notice announcing they are limiting the use of codeine and tramadol medicines in children. These medicines have serious risks, including slowed or difficult breathing and death. Children younger than 12 years appear to be at greater risk and should not use these medicines. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are the FDA-approved only for use in adults. The FDA also recommends against the use of codeine and tramadol medicines in breastfeeding mothers because they may harm their infants.

The FDA is providing the following additional information for caregivers and patients:

  • The FDA is warning about several safety issues with prescription medicines containing codeine used for pain or cough and tramadol used for pain:
  • 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 due to the risk of serious side effects, including slowed or difficult breathing which may lead to death.
  • Codeine is not recommended to treat cough or pain and tramadol is not recommended to treat pain in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease that may increase the risk of serious breathing problems.
  • Tramadol should not be used to treat pain in children up to 18 years of age after surgery to remove their tonsils and/or adenoids. The drug label for codeine already warns against use in children up to 18 years of age after surgery to remove their tonsils and/or adenoids.
  • Breastfeeding is not recommended during treatment with codeine or tramadol because the medicine passes through breast milk and can harm the baby.
  • Talk to your health care provider or a pharmacist to find out if a medicine your child is taking contains codeine or tramadol.
  • Always read the label on prescription bottles to find out if a medicine contains codeine or tramadol, or ask your child’s health care provider or a pharmacist.
  • If patients of any age are known to be CYP2D6 ultra-rapid metabolizers, which means their bodies convert codeine or tramadol into their active forms faster and more completely than usual, they should not use codeine or tramadol.
  • If a child has taken codeine or tramadol and you notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in a child of any age, seek medical attention immediately by taking the child to an emergency room or calling 911.
  • Report any side effects from codeine- or tramadol- containing medicines to your health care professional and the FDA MedWatch program.

CVS Caremark Response:

Please note: There have been no recalls issued on these products because of this action. CVS Caremark Mail Service Pharmacy will continue to dispense these products. For more information, please call a Customer Care representative toll-free at 1-866-823-5184.

For more information about this issue, please call the manufacturer FDA consumer inquiry line toll-free at 1-888-INFO-FDA (1-888-463-6332) or visit their web site at https://www.fda.gov/ .

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