> August 17, 2007
> 
> 
> 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>
> 
> Media Inquiries:
> FDA Press Office, 301-827-6242
> 
> 
> 
> Consumer Inquiries:
> 888-INFO-FDA
> 
> ----- End forwarded message -----
> 
>

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