Drug Safety Alerts

Codeine and Tramadol Medicines MedWatch

4/20/2017

On April 20, 2017, theUnited States Food and Drug Administration (FDA) issued a MedWatch indicated they are restricting the use of codeine and tramadol medicines in children. 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. 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 is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.

The FDA is providing the following additional information for health care professionals:

• The FDA is warning about several safety issues with prescription medicines containing codeine used for pain or cough and tramadol used for pain and requiring the following changes to the drug labels:

• The FDA’s strongest warning, called a Contraindication, alerting that codeine and tramadol should not be used to treat pain in children younger than 12 years, and codeine should not be used to relieve cough in these children.

• A new Contraindication to the tramadol label to restrict its use in children younger than 18 years to treat pain after a tonsillectomy and/or adenoidectomy. The label of codeine-containing products already carry this Contraindication.

• A new Warning to the drug labels of codeine and tramadol to recommend against their use in adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or compromised respiratory function, that may increase the risk of serious breathing problems.

• Strengthening the Warning to patients that breastfeeding is not recommended during treatment with codeine or tramadol due to the potential for serious adverse reactions in a breastfed infant, such as excess sedation, respiratory depression, and death.

• All tramadol-containing products and single-ingredient codeine drugs are FDA-approved for use only in adults.

• If you have determined that a codeine-or tramadol-containing product is appropriate for an adolescent patient, counsel parents and caregivers on how to recognize the signs of opioid toxicity, and advise them to stop giving the adolescent codeine or tramadol and seek medical attention immediately if their adolescent is exhibiting these signs.

• Report adverse events involving codeine- or tramadol- containing medicines to 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 about this issue, health care providers may contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or https://www.fda.gov/.