Has anyone heard the warning from the FDA about codeine use in nursing
mothers. I just received this news article

www.fda.gov/bbs/topics/NEWS/2007/NEW01685.html

 

I <http://www.fda.gov/bbs/topics/NEWS/2007/NEW01685.html#top#top>  tried
Dr. Hale's site but he is not yet accepting new questions.  

 

 

 

 

 

 

 

						

 


FDA Warning on Codeine Use by Nursing Mothers 
May Increase Chance of Serious Side Effects in Infants


The U.S. Food and Drug Administration (FDA) is concerned that nursing
infants may be at increased risk of morphine overdose if their mothers
are taking codeine and are ultra-rapid metabolizers of codeine. The
agency has reviewed all available information on this subject since a
medical journal reported the death of a 13-day old breastfed infant who
died from morphine overdose. The morphine levels in the mother's milk
were abnormally high after taking small doses of codeine to treat
episiotomy pain. A genetic test showed that the mother was an
ultra-rapid metabolizer of codeine. 

"Our best advice to physicians prescribing codeine-containing products
to nursing mothers is to prescribe the lowest dose needed for the
shortest amount of time," said Sandra Kweder, M.D., deputy director of
the Office of New Drugs in FDA's Center for Drug Evaluation and
Research. "And nursing mothers should always consult their physicians
before taking any codeine containing products." 

Codeine is an ingredient found in prescription and non-prescription
medicines that are used to relieve pain or treat cough. Once in the
body, some of the codeine is converted (metabolized) to morphine. Some
people, due to their genetic makeup, metabolize codeine much faster and
more completely than others. These people, called ultra-rapid
metabolizers, are more likely to have higher-than-normal levels of
morphine in their blood after taking codeine. Mothers who are
ultra-rapid metabolizers may have higher-than-usual levels of morphine
in breast milk. 

According to the FDA, nursing mothers have used codeine safely for many
years. In medical practice, codeine is generally considered the safest
choice among narcotic pain relievers for nursing women and their babies.
However, to raise awareness of this possible health risk and to prevent
morphine overdose in nursing infants, FDA is requiring manufacturers of
prescription codeine medicines to include information about codeine
ultra-rapid metabolism in drug package insert information. In addition,
FDA has posted information about this issue on the FDA website for
healthcare providers and patients.

Nursing mothers taking codeine (or other narcotic pain relievers) should
know how to watch for signs of overdose in their babies. Breast fed
babies normally nurse every two to three hours and should not sleep for
more than four hours at a time. Signs of morphine overdose in a nursing
baby include increased sleepiness, difficulty breastfeeding, breathing
difficulties or limpness.

The chance of being an ultra-rapid metabolizer varies among different
population groups from less than 1 per 100 people to 28 per 100 people.
For people who are ultra-rapid metabolizers, the risk of having an
adverse event when taking codeine is not known. The only way to know if
someone is an ultra-rapid metabolizer is to do a genetic test. There is
a FDA-cleared test to check for ultra-rapid metabolism, but there is
only limited information about using this test for codeine metabolism.
At this time, the test result alone may not correctly predict if a
mother's breast milk will have too much morphine if she uses codeine to
treat pain. This test cannot substitute for a doctor's judgment. 

Mothers and babies gain many health benefits from breastfeeding. When a
nursing mother must take medicine, her infant may be exposed to some
risks from that medicine. It is important for healthcare professionals
and nursing women using codeine or other medicines to discuss these
risks and benefits. 

For more information, go to Use of Codeine Products in Nursing Mothers
<http://www.fda.gov/cder/drug/infopage/codeine/default.htm> . 

 


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