AUDIENCE: Pediatrics, OB/GYN, Internal Medicine
ISSUE: FDA is 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 FDA-approved only for use in adults. FDA is also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants.
As a result, FDA is requiring several changes to the labels of all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond the 2013 FDA restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. FDA is now adding:
- FDA's strongest warning, called a Contraindication, to the drug labels of codeine and tramadol alerting that 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 new Contraindication to the tramadol label warning against its use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids.
- 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 severe lung disease, which may increase the risk of serious breathing problems.
- A strengthened Warning to mothers that breastfeeding is not recommended when taking codeine or tramadol medicines due to the risk of serious adverse reactions in breastfed infants. These can include excess sleepiness, difficulty breastfeeding, or serious breathing problems that could result in death.
See the FDA Drug Safety Communication, available at: http://bit.ly/2oOXGj4, for a data summary, a list of approved drugs containing codeine and tramadol, and additional information.
BACKGROUND: Codeine is approved to treat pain and cough, and tramadol is approved to treat pain.
RECOMMENDATION: Health care professionals should be aware that tramadol and single-ingredient codeine medicines are FDA-approved only for use in adults. Consider recommending over-the-counter (OTC) or other FDA-approved prescription medicines for cough and pain management in children younger than 12 years and in adolescents younger than 18 years, especially those with certain genetic factors, obesity, or obstructive sleep apnea and other breathing problems. Cough is often secondary to infection, not serious, and usually will get better on its own so treatment may not be necessary.
Caregivers and patients should always read the label on prescription bottles to find out if a medicine contains codeine or tramadol. You can also ask your child's health care provider or a pharmacist. Watch closely for signs of breathing problems in a child of any age who is taking these medicines or in infants exposed to codeine or tramadol through breastmilk. 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 by going to an emergency room or calling 911.
AUDIENCE: Family Practice, Pediatrics, Surgery, Patient
ISSUE: FDA is investigating the safety of using codeine-containing medicines to treat coughs and colds in children under 18 years because of the potential for serious side effects, including slowed or difficult breathing.
Children, especially those who already have breathing problems, may be more susceptible to these serious side effects. In 2013, FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids.
In April 2015, the European Medicines Agency (EMA) announced that codeine must not be used to treat cough and cold in children under 12 years, and that codeine is not recommended in children and adolescents between 12 and 18 years who have breathing problems, including those with asthma and other chronic breathing problems.
FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Final conclusions and recommendations will be communicated when the FDA review is complete.
RECOMMENDATION: Parents and caregivers who notice any signs of slow or shallow breathing, difficult or noisy breathing, confusion, or unusual sleepiness in their child should stop giving their child codeine and seek medical attention immediately by taking their child to the emergency room or calling 911. Parents and caregivers should always read the product label to find out if a medicine contains codeine and talk with their child's health care professional or a pharmacist if they have any questions or concerns. Health care professionals should continue to follow the recommendations in the drug labels and use caution when prescribing or recommending codeine-containing cough-and-cold medicines to children.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Why is this medication prescribed?
This combination of drugs is used to relieve mild to moderate pain.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
The combination of acetaminophen and codeine comes as a tablet, capsule, and liquid to take by mouth. It usually is taken every 6 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen and codeine exactly as directed.
Codeine can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.
What special precautions should I follow?
Before taking acetaminophen and codeine,
- tell your doctor and pharmacist if you are allergic to acetaminophen, codeine, sulfite or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially acetaminophen (Tylenol); antidepressants; medications for cough, cold, or allergies; other pain relievers; sedatives, sleeping pills, tranquilizers; and vitamins.
- tell your doctor if you have or have ever had liver or kidney disease, a history of alcoholism, lung or thyroid disease, prostatic hypertrophy, or urinary retention.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen and codeine, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking acetaminophen and codeine.
- you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
- remember that alcohol can add to the drowsiness caused by this drug.
What should I do if I forget a dose?
This medication usually is taken as needed. If your doctor has told you to take acetaminophen and codeine regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Acetaminophen and codeine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- upset stomach
- stomach pain
- difficulty urinating
If you experience either of the following symptoms, call your doctor immediately:
- difficulty breathing
- mood changes
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What other information should I know?
Keep all appointments with your doctor.
Too much acetaminophen may cause liver damage; do not take more than 4000 mg of acetaminophen per day.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Brand names of combination products
- Capital® & Codeine (containing Acetaminophen, Codeine)
- Codrix® (containing Acetaminophen, Codeine)¶
- Empracet® (#3, #4) (containing Acetaminophen, Codeine)¶
- Fioricet® with Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)
- Papa-deine® (#3, #4) (containing Acetaminophen, Codeine)¶
- Phenaphen® with Codeine (#2, #3, #4) (containing Acetaminophen, Codeine)¶
- Phrenilin® with Caffeine, Codeine (containing Acetaminophen, Butalbital, Caffeine, Codeine)
- Proval® #3 (containing Acetaminophen, Codeine)¶
- Tylenol® with Codeine (#3, #4) (containing Acetaminophen, Codeine)
- APAP and Codeine (containing Acetaminophen and Codeine)
¶ This branded product is no longer on the market. Generic alternatives may be available.