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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