Navigation Links
FDA Warns of Codeine Risk for Some Nursing Mothers
Date:8/18/2007

Some women metabolize the drug quickly, raising chance of morphine overdose for baby

FRIDAY, Aug. 17 (HealthDay News) -- Nursing mothers who use medicines containing codeine and metabolize the drug quickly may be putting their baby at risk of a morphine overdose, U.S. health officials said Friday.

The U.S. Food and Drug Administration's warning was prompted by a report of the death of a 13-day-old breast-fed infant who died from morphine overdose. In that case, researchers found abnormally high morphine levels in the milk of the mother, who had been taking codeine to treat pain from an episiotomy. A genetic test found that the mother was an "ultra-rapid metabolizer" of codeine.

"Infants of nursing mothers who are taking codeine can have an increased risk of morphine overdose if the mother is an ultra-rapid metabolizer of codeine," Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs at the Center for Drug Evaluation and Research, said during a teleconference.

These women are genetically predisposed to metabolize codeine more rapidly and completely than other people, Kweder said. The pain-relieving effect of codeine occurs as some of it is metabolized into morphine, she explained.

Codeine is found in prescription and non-prescription medicines and used to relieve pain or treat cough. "Its use to manage pain after delivery is very common," Kweder said.

Ultra-rapid metabolizers of codeine are likely to have higher levels of morphine in their blood after taking usual doses of the drug, Kweder said. "Nursing mothers who are ultra-rapid metabolizers may also have higher morphine levels in their breast milk," she said. "These higher levels of morphine can affect the baby and lead to very severe, even life-threatening side effects in nursing babies."

Kweder advised doctors who prescribe codeine to nursing mothers to prescribe the lowest dose for the shortest amount of time. Doctors should also tell women how to recognize the signs of high morphine levels in themselves and their babies, she said.

Nursing mothers taking codeine should call their doctor if they become sleepy to the point of having difficulty taking care of the baby, Kweder advised.

As for symptoms of morphine overdose in babies, they include "signs of increased sleepiness, difficulty breast-feeding and especially breathing difficulties, or limpness," Kweder said. The mother should call the doctor immediately, she said, adding that if the doctor can't be reached, the "baby should be taken to an emergency room right away."

People who are ultra-rapid metabolizers of codeine usually don't know it, Kweder said. The number of people who are ultra-rapid metabolizers varies widely among different groups of people.

Among whites, 1 percent to 10 percent have the genetic potential. For blacks, it's about 3 percent, and for Hispanics and Asians, it's about 1 percent. But, for North Africans, Ethiopians and Saudi Arabians, the prevalence is between 16 percent and 28 percent, she said.

"The only way to know you are an ultra-rapid metabolizer is with a genetic test," Kweder said. There is an FDA-approved test that is widely available. "But our message is that while the test is widely available, it can be useful, but it is not a substitute for a doctor's judgment," she said.

While codeine products are safe for most people, the FDA asks that manufacturers of products containing codeine -- both prescription and over-the-counter -- add information to the label about the phenomenon of codeine ultra-rapid metabolism, especially as it relates to breast-feeding.

More information

For more on codeine, visit the U.S. Library of Medicine.



SOURCE: Aug. 17, 2007, teleconference with Sandra Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration


'/>"/>

Copyright©2007 ScoutNews,LLC.

Related medicine news :

1. International community warns India on HIV situation
2. Thakur warns doctors
3. Paracetamol May Cause Live Damage Warns Consumer Education and Research Centre
4. Study Warns About The Use Of Popular Asthma Drug To Stop Childrens Coughs
5. Indian Government warns Gujarat regarding possibility of bird flu
6. ADB Report Warns of Bird-Flu Catastrophe
7. FDA Warns Against Birth-Control Patch
8. Charlotte Church Warns kiss n tell girls not to flirt with Henson
9. UK Committee Warns on Food Shortages Due to Flu Epidemic
10. NHS Audit Commission Warns Possible Financial Collapse In Sussex And Surrey
11. Russia warns against travel to Turkey, Iran closes border
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas of ... AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct to ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative ... has initiated cultivation and processing operations at its production facility, and opened its ... Puradigm is the manufacturer of a complete system of proactive air and surface ...
(Date:6/24/2016)... ... , ... Venture Construction Group (VCG) sponsors Luke’s Wings ... the Woodmont Country Club at 1201 Rockville Pike, Rockville, Maryland, 20852. The event ... that have been wounded in battle and their families. Venture Construction Group is a ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... startling report released today, National Safety Council research shows ... plan to eliminate prescription opioid overdoses. Prescription Nation ... the worst drug crisis in recorded U.S. history, assigned a "Making ... , New Mexico , Tennessee ... states, three – Michigan , Missouri ...
(Date:6/23/2016)... Research and Markets has announced the ... report to their offering. ... favourable commercial environment for MedImmune to enter. The US ageing ... serve to drive considerable growth for effective anti-influenza medications. The ... sales considerably, but development is still in its infancy. ...
(Date:6/23/2016)... and BOGOTA, Colombia , June 23, 2016  Astellas today announced the establishment of ... Farma Brasil as the company,s second affiliate in Latin America . ... ... Manager of Astellas Farma Colombia ... ...
Breaking Medicine Technology: