Wednesday, April 4, 2018

Codeine and Tramadol medicines in children; Serious risk including difficulty in breathing and death


ADR BULLETIN
Codeine and Tramadol medicines in children;
Serious risk including difficulty in breathing and death

Codeine and tramadol are a type of narcotic medicine called an opioid. Codeine is used to treat mild to moderate pain and also to reduce coughing. It is usually combined with other medicines, such as acetaminophen, in prescription pain medicines. It is frequently combined with other drugs in prescription and over-the-counter (OTC) cough and cold medicines. Tramadol is a prescription medicine approved only for use in adults to treat moderate to moderately severe pain. However, data show it is being used in children and adolescents despite the fact that it is not approved for use in these patients.

FDA is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. 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 signs include slow or shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness. If you notice any of these signs, stop giving the medicine and seek medical attention immediately. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. FDA also recommends against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.

A review of several decades of adverse event reports submitted to FDA identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18 years. This includes only reports submitted to FDA, so there may be additional cases about which we are unaware. They also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol in children younger than 18 years from January 1969 to March 2016 . The majority of serious side effects with both codeine and tramadol occurred in children younger than 12 years, and some cases occurred after a single dose of the medicine.Data regarding codeine use during breastfeeding,  numerous cases of excess sleepiness and serious breathing problems in breastfed infants, including one death was observed.


Additional information to patients:
·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 and 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 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.
· 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 .
·Report any side effects from codeine- or tramadol- containing medicines to your health care professional.

Additional information for health care professionals:

·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:
·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


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