FDA has important new information about a very rare, but serious, side effect in 
nursing infants whose mothers are taking codeine.  Differences in drug metabolism 
among mothers taking codeine may contribute to side effects in nursing infants.

Infants of nursing mothers taking codeine may have an increased risk of morphine 
overdose if the mother is an ultra-rapid metabolizer of codeine.  When codeine 
enters the body and is metabolized, it changes to morphine, which relieves pain.  
Many factors affect codeine metabolism, including a person’s genetic make-up. 
Some people have a variation in a liver enzyme and may change codeine to 
morphine more rapidly and completely than other people.  These people are ultra-
rapid metabolizers and are more likely to have higher than normal levels of morphine 
in their blood after taking codeine.  Nursing mothers taking codeine may also have 
higher morphine levels in their breast milk. These higher levels of morphine in breast 
milk may lead to life-threatening or fatal side effects in nursing babies.  In most 
cases, it is unknown if someone is an ultra-rapid codeine metabolizer. Codeine is an 
ingredient in many prescription pain relievers and some over-the-counter cough 
syrups.  FDA is issuing this public health advisory to inform healthcare professionals 
and nursing mothers about the following important safety information:

*When prescribing codeine for a nursing mother, doctors should prescribe the 
lowest dose for the shortest amount of time to relieve pain or cough.  Doctors 
need to tell their nursing patients how to recognize signs of high morphine levels in 
themselves and their babies. 

*If you are a nursing mother taking codeine, call your doctor if you become 
extremely sleepy and have trouble caring for your baby. 

*Breastfed babies usually nurse every two to three hours and should not sleep 
more than four hours at a time.  If your baby shows signs of increased sleepiness 
(more than usual), difficulty breastfeeding, breathing difficulties, or limpness, talk 
to the baby’s doctor immediately.  If you cannot reach the doctor right away, take 
the baby to an emergency room or call 911 (or local emergency services).  

*Nursing mothers should talk to their doctors if they have any questions about 
taking codeine.  

FDA has asked the makers of prescription codeine-containing products to include 
information about differences in codeine metabolism and concerns with 
breastfeeding in the drug label. Doctors who prescribe codeine need to be aware of 
the potential for the increased risks to breastfeeding babies of mothers who are 
ultra-rapid metabolizers of codeine.  The FDA urges healthcare providers and 
nursing mothers to report side effects that occur while using codeine to the FDA's 
MedWatch Adverse Event Reporting program  by phone at 1-800-332-1088 or on-
line at  www.accessdata.fda.gov/scripts/medwatch/medwatch-
online.htm/

The FDA announced that, in October, the Nonprescription Drugs Advisory 
Committee will discuss the safety and effectiveness of cough and cold drug 
product use in children. Questions have been raised about the safety of these 
products and whether the benefits justify any potential risks from the use of these 
products in children, especially in children under 2 years of age.  Reports of serious 
adverse events associated with the use of these products appear to be the result 
of giving too much of these medicines to children.  An over-the-counter (OTC) 
cough and cold medicine can be harmful if more than the recommended amount is 
used, if it is given too often, or if more than one cough and cold medicine 
containing the same active ingredient are being used.  To avoid giving a child too 
much medicine, parents must carefully follow the directions for use of the product 
in the “Drug Facts” box on the package label.  What should parents know about 
using cough and cold products in children?  Visit link above.

A number of national pharmacy organizations, emergency preparedness groups and 
a pharmaceutical trade association announced creation of Rx Response – a 
program designed to help support the continued delivery of medicines during a 
severe public health emergency. The partnership includes the American Hospital 
Association, American Red Cross, Biotechnology Industry Organization, Healthcare 
Distribution Management Association, National Association of Chain Drug Stores, 
and the National Community Pharmacists Association..  Additionally, the partnership 
is working with state emergency agencies to further develop the program to help 
support the continued delivery of medications to patients whose health may be 
threatened during a crisis. 

Rx Response will help support information sharing among partners, community 
volunteer relief organizations and local, state and federal agencies responding to 
major disasters by helping to support the continued delivery of critical medicines 
and, where possible, addressing challenges. The Rx Response offers visitors the 
opportunity to print a medication wallet card – in English or Spanish – to list 
medications and other relevant medical information in case of emergency.

The National Council on Patient Information and Education (NCPIE) today 
released, “Enhancing Prescription Medicine Adherence:  A National Action Plan.”  
The report offers a comprehensive review of the extent and nature of poor 
medicine adherence, its health and economic costs, and its underlying factors. 
Included are 10 action steps / recommendations that can significantly impact 
medication adherence and can be readily implemented.  

U.S. Senator Joseph R. Biden, Jr., (D-Del.) introduced a Senate resolution 
designating August 2007 as "National Medicine Abuse Awareness Month." The 
initiative highlights the month of August—when students nationwide will be 
preparing for the upcoming school year - as an opportunity for parents to educate 
themselves and to talk to their teens about the dangers associated with medicine 
abuse.  For more, see: www.stopmedicineabuse.org/