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Gentle Nurturing - Lactation Consultant - Childbirth and Doula Services
Gentle Nurturing - Lactation Consultant - Childbirth and Doula Services
 
 
Gentle Nurturing - Lactation Consultant - Childbirth and Doula Services



What is all the fuss about chemicals in toys? Print E-mail
Written by Jon Hamilton, NPR All Thing's Considered   
Tuesday, 29 July 2008

Phthalates banSee also: Ban Weighed On Children's Toy Ingredient

House and Senate lawmakers this week moved toward banning some types of phthalates, a family of chemicals found in many soft plastic children's toys. Here, a look at where phthalates are found and the health concerns they raise.

What are phthalates?

They're chemicals widely used to soften plastics such as vinyl. Manufacturers use hundreds of million of pounds of phthalates each year in products including children's toys.

What kinds of toys are they found in?

They're found in a variety of soft toys, including some rubber ducks, bath books and soft vinyl blocks. However, about a decade ago, companies voluntarily removed phthalates from toys specifically designed to be chewed by children, such as teething rings and rattles.

What are the health concerns?

Phthalates are part of a group of chemicals called "endocrine disruptors." Some of these chemicals act like a hormone in the body; others block the effect of the body's own hormones. Health concerns center on what happens when children chew on toys containing phthalates, and small amounts get into their bodies. Just handling toys isn't a problem. There are more than a dozen phthalates in common use. Studies have shown that some of these phthalates can cause reproductive problems in rodents, but the effect on humans is under much debate.

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Ban Weighed On Children's Toy Ingredient Print E-mail
Written by David Kestenbaum, NPR All Thing's Considered   
Tuesday, 29 July 2008

Phthalates banFederal lawmakers are moving toward a ban on using certain chemicals called phthalates in children's toys. Phthalates are chemicals that are used to make plastics more flexible.

See also: What Is All The Fuss About Chemicals In Toys?

Read more...
 
Fighting the Autism-Vaccine War Print E-mail
Written by Bernadine Healy M.D., US News & World Report   
Tuesday, 15 April 2008
A Vaccine Trigger?
As a trigger, vaccines carry a ring of historical and biological plausibility.
(Phil Klein/Reuters/Corbis)
One of the most vitriolic debates in medical history is just beginning to have its day in court--vaccine court, that is. Without laying blame, the independent Office of Special Masters of the Court of Federal Claims--with a 20-year record of handling vaccine matters--recently conceded that the brain damage and autistic behavior of Hannah Poling stemmed from her exposure as a toddler to five vaccinations on one day in July 2000. Two days later, she was overtaken by a high fever and an encephalopathy that deteriorated into autistic behavior. Even though autism has a strong genetic basis, and she has a coexisting rare mitochondrial disorder, I would not be too quick to dismiss Hannah as an anomaly.

At some level, the decision was a vindication for families who have been battling with the vaccine community, arguing that some poorly understood reaction to components of vaccines or their mercury-based preservative, thimerosal, could cause brain injury. Yes, vaccines are extraordinarily safe and bring huge public health benefit. (Remember the 1950s polio epidemics?) But vaccine experts tend to look at the population as a whole, not at individual patients. And population studies are not granular enough to detect individual metabolic, genetic, or immunological variation that might make some children under certain circumstances susceptible to neurological complications after vaccination.

A trigger? Families are not alone in searching for a trigger that might explain why autism and autism spectrum disorders have skyrocketed; now they reportedly affect about 1 in 150 kids. No doubt some of the increase is soft, due to broader diagnostic criteria, greater awareness, and--now that the notion of a detached "refrigerator" mom as a cause has blessedly fallen by the wayside--greater openness. But the rise of this disorder, which shows up before age 3, happens to coincide with the increased number and type of vaccine shots in the first few years of life. So as a trigger, vaccines carry a ring of both historical and biological plausibility.

Go back 40 or 50 years. The medical literature is replete with reports of neurological reactions to vaccines, such as mood changes, seizures, brain inflammation, and swelling. Several hundred cases of the paralytic illness Guillain-Barré after the swine flu vaccine were blamed on the government and gave Gerald Ford heartburn--but eventually led to the vaccine court.

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Public Forum to Address Safety Issues on Vaccines Print E-mail
Written by Gardiner Harris, The New York Times   
Friday, 11 April 2008

WASHINGTON -- In the midst of yet another controversy about whether vaccines cause autism, the federal government will hold its first ever public meeting on Friday to discuss a governmentwide research agenda to explore the safety of vaccines.

The meeting is intended to help defuse years of criticism from vaccine skeptics that the government is hiding what it knows about vaccine safety or failing to investigate the issue diligently.

But the gathering is unlikely to appease the government's many critics in part because the latest notion to grip vaccine skeptics -- that vaccinations trigger or worsen something called mitochondrial dysfunction, which in turn causes autism -- will remain largely unaddressed.

"I think there could be real frustration," Dr. Bruce Gellin, director of the National Vaccine Program Office, which is coordinating the meeting, said in an interview Thursday.

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Tainted Drugs Tied to Maker of Abortion Pill Print E-mail
Written by Jake Hooker and Walt Bogdanich, The New York Times   
Thursday, 31 January 2008
A patient in Shanghai
Ariana Lindquist for The New York Times.
A patient in Shanghai who was paralyzed by a tainted drug.

Beijing -- A huge state-owned Chinese pharmaceutical company that exports to dozens of countries, including the United States, is at the center of a nationwide drug scandal after nearly 200 Chinese cancer patients were paralyzed or otherwise harmed last summer by contaminated leukemia drugs.

Chinese drug regulators have accused the manufacturer of the tainted drugs of a cover-up and have closed the factory that produced them. In December, China's Food and Drug Administration said that the Shanghai police had begun a criminal investigation and that two officials, including the head of the plant, had been detained.

The drug maker, Shanghai Hualian, is the sole supplier to the United States of the abortion pill, mifepristone, known as RU-486. It is made at a factory different from the one that produced the tainted cancer drugs, about an hour's drive away.

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WIC Frontlines Already Feel Recession Print E-mail
Written by CalWIC.org   
Friday, 25 January 2008

Despite Congressional restoration of "adequate" WIC funding in the final days of the session, California WIC local agencies are struggling to meet rising need caused by economic downturn and high food costs.

California WIC

Many agencies are serving over 100% of allocated caseload targets. Others report facing severe challenges in keeping their caseloads at their target levels, despite taking steps to slow down participation without actually limiting enrollment, such as shutting down outreach and reminder calls, and limiting "walk-ins." Since last summer, California WIC programs have noticed more "new enrollments" -- a sure sign that young families are experiencing fiscal emergencies caused by foreclosures or layoffs, and turning to WIC for help. The story is the same all over the nation. WIC advocates are beginning to wonder whether our current-year funding, including the entire Contingency Fund, will really be enough to get WIC through the year -- we may need to seek Supplemental Appropriations.

Local WIC Directors: Plan to attend your regional meetings and the State Task Force Meeting on February 13-14 so we can meet this challenge together! Come prepared to tell your stories.

Stimulus Package Needs Your Stimulus!

Congress is rushing to pass legislation to stimulate the economy with a package of short-term boosts such as tax rebates. But the package announced yesterday by the President and Leaders on the Hill still falls short of what is needed both as a stimulus and as a support for those struggling with rapidly rising costs for food, energy, and housing. In particular, the current package contains no temporary boost in food stamp benefits and no unemployment insurance extension, even though many economists are urging these two measures as the quickest and most targeted strategies. There is still a chance to insert food and jobless help as the Stimulus Package goes to the Senate. This is what WIC families really need!

Action: In the next week, PLEASE call, or email, California Senators Boxer and Feinstein and tell them to talk to their Finance Committee colleagues with this message: "A temporary food stamp benefit boost and an unemployment insurance extension are the two best ways to stimulate the economy and to cushion the blow on people hard hit by a weakened economy, and both must be included in stimulus legislation." See this fact sheet for information and arguments in favor of a temporary increase in food stamp allotments.

California WIC 

 
FDA to declare cold medicines too risky for babies, toddlers Print E-mail
Written by The Associated Press   
Thursday, 17 January 2008

FDA to declare cold medicines too risky for babies, toddlersWASHINGTON (AP) -- Parents should not give sniffling babies and toddlers over-the-counter cough and cold medicines -- they're too risky for tots so small, the government will declare Thursday.

The Food and Drug Administration still hasn't decided if the remedies are appropriate for older children to continue using, officials told The Associated Press.

Expect a decision on that by spring, the deadline necessary to notify manufacturers before they begin production for next fall's cold season.

For now, the FDA is issuing a public health advisory on Thursday to warn parents to avoid these drugs for children under age 2 "because serious and potentially life-threatening side effects can occur."

It's not the first warning about cold remedies and tots: Drug companies last October quit selling dozens of versions targeted specifically to babies and toddlers. That same month, the FDA's own scientific advisers voted that the drugs don't even work in small children and shouldn't be used in preschoolers, either -- anyone under age 6.

Thursday's advisory marks the government's first ruling on the issue: Don't give the drugs to children under 2. And it comes now because the FDA is worried that parents haven't gotten that message despite all the publicity last fall.

They may still have infant-targeted drugs at home, or they may buy drugs meant for older children to give to hacking tots instead, said Dr. Charles Ganley, FDA's nonprescription drugs chief.

Read more...
 
'Endocrine disruptor' won't be on label Print E-mail
Written by Liz Szabo, USA Today   
Monday, 05 November 2007

Though scientists, environmentalists and manufacturers probably will debate the dangers of chemicals in popular products for years to come, many consumers wonder what they can do today to make "greener" choices at the store.

Unfortunately, experts say, deciphering the labels of personal and household products isn't as simple as selecting organic produce. There's no standard, enforceable definition of a "non-toxic" or "environmentally friendly" household cleaner, says Urvashi Rangan, senior scientist and policy analyst at Consumers Union. Such terms don't provide consumers with any real guarantees about products' ingredients, she says.

There's no real standard for "natural" or "organic" cosmetics, either, says Jane Houlihan, vice president for research at the Environmental Working Group.

The Food and Drug Administration requires that cosmetics companies test their products for safety so consumers don't develop a rash or eye infection. But it doesn't require companies to study whether products contain chemicals such as endocrine disruptors.

Read more...
 
Poll Results: Over-The-Counter Cold and Cough Medicines Print E-mail
Written by Medscape Medical News   
Sunday, 04 November 2007

On October 19, an FDA panel recommended that over-the-counter cold and cough medicines should not be used in children aged 2 to 5 years. Do you agree or disagree with this decision?

Poll Results

Total Responses: 5170
Poll conducted 30-Oct-2007 - 06-Nov-2007

 
New Nutritional Guide for Pregnant, Nursing Moms Announced Print E-mail
Written by Regina Sass, Associated Content   
Monday, 29 October 2007

MyPyramid.govActing Secretary of Agriculture Chuck Conner has announced that they have developed a new MyPyramid nutritional guide line for pregnant and breastfeeding mothers. It can be found at MyPyramid.gov. The site provided unique and individualized guidance.

The project is a joint effort of The Department of Agriculture and the George Washington University Medical Center. In addition to helping moms and moms to be, it can also help obstetricians and other health care professionals. MyPyramid has been on line since 2005 and since then, has had more the 3.9 million visitors, so they are confident that the new specialized pyramid will be a tremendous success.

The site was developed by the USDA Center for Nutrition Policy and Promotion, along with the Food and Nutrition Service's Women, Infants and Children Program and the Department of Health and Human Services, and it follows that latest nutrition guidelines that were established in 2005.

Getting your own personalized MyPyramid Plan for Moms is easy and it can be done in minutes just by following a few simple steps. All a pregnant woman needs to do is to enter her age, height, weight before she became pregnant, their level of physical activity and their due date. A mom who is breastfeeding enters the same information, plus things like the baby's date of birth, and whether or not they are feeding the baby breast milk only or if they are also feeding the baby formula. Once this is done, they will see their personalized plan and it can be downloaded to the computer and printed out in full color.

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F.D.A. Panel Urges Ban on Medicine for Child Colds Print E-mail
Written by Gardiner Harris, The New York Times   
Saturday, 20 October 2007


Dr. John Jenkins 


Susan Walsh/Associated Press

Dr. John Jenkins, director of F.D.A.'s office of new drugs, urged parents to read labels

Silver Spring, Md., Oct. 19 -- A Food and Drug Administration advisory panel voted Friday to ban popular over-the-counter cold products intended for children under the age of 6.

The panel found there was no proof that the medicines eased cold symptoms in children, while there are rare reports that they have caused serious harm.

If put into practice, the ban could transform pharmacy shelves and change the way parents cope with the most common illness in young children. The vote comes a week after major manufacturers agreed to withdraw more than a dozen cold products labeled for use in infants and babies.

But manufacturers said they would fight the new recommendations.

"We believe these products will remain on the market," said Linda Suydam, president of the Consumer Healthcare Products Association, a trade group.

A forced withdrawal might take years to carry out, top drug agency officials said.

"We need to go back and review all these recommendations that we heard today and decide what the path forward might be," Dr. John Jenkins, director of the office of new drugs at the agency, said after the meeting.

If the agency decides to adopt the committee's recommendation, it must undertake a rule-making process that can "take anywhere from one to many years," Dr. Jenkins said.

While the panel voted, 21 to 1, to ban over-the-counter pediatric cold products for use in children under 2, its vote to ban them for 2- to 5-year-olds was 13 to 9. The F.D.A. usually follows the advice of its expert panels, but the closer the vote, the more likely the agency is to ignore it.

Dr. Joshua Sharfstein, Baltimore's commissioner of health and a co-author of a petition that led to the F.D.A. review of the safety of the medicines, said drug makers and the agency should agree to a quick end to the marketing of cold medicines for children under 6.

"After the advisory committee's clear vote, there is no justification for formulations of these products geared at toddlers or depicting small children," Dr. Sharfstein said.

Whatever the outcome in the marketplace, the panel's advice for parents was clear. They should not use over-the-counter cold medicines in young children.

Read more...
 
California OKs phthalates ban on children's products Print E-mail
Written by Reuters   
Monday, 15 October 2007

Phthalates BanSAN FRANCISCO (Reuters) -- Siding with activists who urged action against "toxic toys," California Gov. Arnold Schwarzenegger signed a bill on Sunday banning chemicals called phthalates in children's products.

The bill aimed at the chemicals used to help mold and smooth toys and other plastic products such as teething rings comes amid growing concern among U.S. consumers over substances used by manufacturers in China to make toys, prompting recalls, including by Mattel Inc., the world's biggest toy maker.

Phthalates Ban "We must take this action to protect our children," Schwarzenegger said in a statement. "These chemicals threaten the health and safety of our children at critical stages of their development."

The bill prohibits the manufacture, sale and distribution of toys and child care products used by children under the age of three that contain phthalates, which have been linked to cancer and reproductive defects, according to the governor's office.

Schwarzenegger in a separate statement urged lawmakers to support his administration's Green Industry Initiative to take a comprehensive approach toward evaluating health effects of chemicals.

"While I believe the circumstances related to phthalates warrant taking action now, I do not believe that addressing this type of concern in the legislature on a chemical by chemical, product by product basis is the best or most effective way to make chemical policy in California," Schwarzenegger said.

 
FDA to Weigh In on New Label for Cough Medicines Print E-mail
Written by Allison Aubrey, NPR Morning Edition   
Thursday, 04 October 2007

(Click to view recommendations for treating a child's cold without cough medicine.)

FDA weighs in on children's cold medicines. Morning Edition, October 4, 2007 -- A petition before the Food and Drug Administration could change the way parents are advised to use cold and cough medicines. The issue is not new. Back in 1997, the American Academy of Pediatrics issued its first policy statement on cough medicines. The nation's leading group of pediatricians said that cough medicines should not be given to children because there is a lack of evidence demonstrating their safety and effectiveness.

The issue gained traction earlier this year when Baltimore's Commissioner of Health sent a petition to the Food and Drug Administration asking for a new warning label for over-the-counter anti-tussives, expectorants, nasal decongestants, antihistamines and combination cough-and-cold products. The petition was signed by a prominent group of Baltimore pediatricians, and it asks for a strongly worded statement telling parents that the products should not be used for treatment of cough and cold in children under 6 years of age.

Cough Medicine Relief and the Placebo Effect

A lot of parents continue to use cough and cold medicines, which are a $2 billion-a-year industry. Mother Robin Wilner of the Washington, D.C., area says she turns to cough syrups in the evenings when her children are sick. "It certainly helps them getting to sleep," Wilner says.

Research, however, suggests the benefits that parents perceive is really nothing more than the placebo effect.

"I don't believe that these medications, in the recommended doses ... are dangerous," says Dr. Ian Paul, a pediatrician at Penn State College of Medicine. "But I don't believe they work."

When cold and cough medicines were approved for over-the-counter use in children back in the 1970s, manufacturers were not required to conduct studies to document their safety or their effectiveness.

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The White House vs. mother's milk Print E-mail
Written by Wendy Orent, The Los Angeles Times   
Sunday, 30 September 2007

The Bush administration squelched ads promoting the benefits of breast-feeding.

What science the Bush administration chooses to stifle or promote seems to be a matter of politics and economics. According to a recent story in the Washington Post, the multibillion-dollar baby formula industry pressured the Department of Health and Human Services to weaken a 2004 public-service campaign promoting breast-feeding -- and it worked, even though the science supported the other side.

The White House vs Mother's Milk

Numerous studies suggest that breast milk protects infants from developing certain illnesses and that formula-feeding increases their health risks.

The ad campaign was designed to drive home that point. Now the health of millions of infants is at risk because mothers don't have the scientific knowledge the ads would have conveyed to make an informed choice between breast- or formula-feeding.

According to the Post, a recent report by an agency within the Health and Human Services Department makes the same point as the canceled ads but has also been downplayed by the government because of pressure from the formula industry.

The original ad campaign was sponsored by the department's Office on Women's Health and developed by the Ad Council, a nonprofit group that produces public-service TV commercials. One spot shows a pregnant woman riding a mechanical bull while a voice-over says, "You wouldn't take such risks while you were pregnant -- why take them afterward? Babies were born to be breast-fed." Another ad features a hypodermic needle lying alongside a nipple-topped insulin bottle -- and states that formula-fed infants are 40% more likely to develop Type 1 diabetes. The ads aimed to shock women into an awareness that the risks of not breast-feeding their infants were real.

Ad Council proposed campaign poster


According to Gina Ciagne, a former public affairs specialist in the women's health office who worked on the campaign: "Very soft campaigns had always been used for breast-feeding. These weren't resonating. We needed something to break through the clutter."

Formula companies got wind of the ads on the Ad Council's website and immediately tried to kill them. Powerful economic interests were at stake. For Abbott Laboratories, Mead Johnson Nutritionals, Wyeth Nutrition and Nestle Nutrition, feeding babies is big business. For instance, in 2006, according to public filings with the Securities and Exchange Commission, Abbott Nutrition, a division of Abbott Laboratories and the industry leader, sold more than $1 billion worth of these products in the United States alone.

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Ban Sought on Cold Medicine for Very Young Print E-mail
Written by Gardiner Harris, The New York Times   
Saturday, 29 September 2007
Ban Sought on Cold Medicine for Very YoungWASHINGTON, Sept. 28 -- Safety experts for the Food and Drug Administration urged the agency on Friday to consider an outright ban on over-the-counter, multisymptom cough and cold medicines for children under 6.

The recommendation, in a 356-page safety review, is the strongest signal yet that the agency may take strong action against the roughly 800 popular medicines marketed in the United States under names like Toddler's Dimetapp, Triaminic Infant and Little Colds.

The next step in the process is a meeting of outside experts on Oct. 18 and 19 to examine the medicines' safety and offer recommendations to the agency.

In the new safety review, the agency's experts suggested that all "infant" cough and cold formulations be removed from the market, and that the droppers, cups and syringes included with products for children be standardized to reduce the risks of confusion and overdose.

The reviewers wrote that there is little evidence that these medicines are effective in young children, and there are increasing fears that they may be dangerous. From 1969 to 2006, at least 54 children died after taking decongestants, and 69 died after taking antihistamines, the report said. And it added that since adverse drug reactions are reported voluntarily and fitfully, the numbers were likely to significantly understate the medicines' true toll.

The Consumer Healthcare Products Association, an industry trade group that has consistently defended the safety of pediatric cough and cold medicines, recommended in its own 156-page safety review, also released on Friday, that the F.D.A. consider mandatory warning labels saying that they should not be used in children younger than 2. Many cough and cold medicines now advise parents to "consult a physician" before use in such children.

The proposed warnings "are recommendations that we have brought forth, and we look forward to having a thorough discussion with the F.D.A.," said Virginia Cox, a spokeswoman for the trade group.

Despite the industry's recommendation, many companies -- including such giants as Johnson & Johnson -- continue to sell cough and cold medicines with "infant" in their titles and pictures of babies on their labels.

Read more...
 
HHS Toned Down Breast-Feeding Ads Print E-mail
Written by Marc Kaufman and Christopher Lee, The Washington Post   
Friday, 31 August 2007

Formula Industry Urged Softer Campaign

Clayton Yeutter, April 2004 

In an attempt to raise the nation's historically low rate of breast-feeding, federal health officials commissioned an attention-grabbing advertising campaign a few years ago to convince mothers that their babies faced real health risks if they did not breast-feed. It featured striking photos of insulin syringes and asthma inhalers topped with rubber nipples.

Plans to run these blunt ads infuriated the politically powerful infant formula industry, which hired a former chairman of the
Republican National Committee and a former top regulatory official to lobby the Health and Human Services Department. Not long afterward, department political appointees toned down the campaign.

The ads ran instead with more friendly images of dandelions and cherry-topped ice cream scoops, to dramatize how breast-feeding could help avert respiratory problems and obesity. In a February 2004 letter (pdf), the lobbyists told then-HHS Secretary Tommy G. Thompson they were "grateful" for his staff's intervention to stop health officials from "scaring expectant mothers into breast-feeding," and asked for help in scaling back more of the ads.

The formula industry's intervention -- which did not block the ads but helped change their content -- is being scrutinized by Congress in the wake of last month's testimony by former surgeon general Richard H. Carmona that the Bush administration repeatedly allowed political considerations to interfere with his efforts to promote public health.

Rep. Henry A. Waxman's Committee on Oversight and Government Reform is investigating allegations from former officials that Carmona was blocked from participating in the breast-feeding advocacy effort and that those designing the ad campaign were overruled by superiors at the formula industry's insistence.

"This is a credible allegation of political interference that might have had serious public health consequences," said Waxman, a California Democrat.

The milder campaign HHS eventually used had no discernible impact on the nation's breast-feeding rate, which lags behind the rate in many European countries.

Read more...
 
Spitzer signs law protecting nursing moms at work Print E-mail
Written by Associated Press   
Friday, 24 August 2007

"A woman should not be forced to sacrifice her ability to provide for her children economically or nutritionally," said Spitzer, who signed the law last week. "This modest accommodation allows mothers who choose to breast-feed to continue their invaluable contribution to the economy without fearing for their job." 

ALBANY, N.Y. (AP) -- Governor Spitzer has signed a new law that will allow mothers to keep providing breast milk to their babies after returning to work.

The law requires employers to provide time and private space for women to express milk or nurse their children for up to three years following the birth of a child.

Spitzer said allowing women to breastfeed will benefit both businesses and families. Employees' dedication to the workplace will be strengthened, and children will benefit from the nutritional value of breast milk.

The Assembly and the Senate unanimously approved the legislation.

Assemblywoman Roann Destito sponsored the bill. She said a young mother was fired in her district for expressing breast milk for her baby. She said the new law ensures that won't happen again.

(Note: Oregon passed a similar bill in May, and several other states are pushing for legislation. See also: 50 State Summary of Breastfeeding Laws.)

 
FDA: Codeine Risk for Some Nursing Moms Print E-mail
Written by Associated Press   
Friday, 17 August 2007

FDAWASHINGTON -- Nursing mothers who take codeine should watch their infants for increased sleepiness or other signs of overdose, federal health officials warned Friday.

The Food and Drug Administration warning of the rare but serious side effect was prompted by a 2006 report of the death of a nursing infant whose mother was given codeine for episiotomy pain.

Genetic testing later showed the woman's body converted the codeine to morphine more rapidly and completely than in other people. That led to higher-than-expected morphine levels in her breast milk.

While the rapid conversion of codeine to morphine is a very rare side effect in some mothers, it can result in high and unsafe levels of the latter drug in the blood and breast milk, the FDA said in an alert.

Codeine is among the most common drugs taken by new mothers, FDA officials said.

It is included in several prescription pain drugs and in some over-the-counter cough syrups, Dr. Sandra Kweder, the FDA's deputy director, Office of New Drugs, Center for Drug Evaluation and Research, said in a telephone briefing.

Read more...
 
FDA Warning on Codeine Use by Nursing Mothers Print E-mail
Written by FDA   
Friday, 17 August 2007

May Increase Chance of Serious Side Effects in Infants

FOR IMMEDIATE RELEASE
August 17, 2007

Consumer Inquiries:
888-INFO-FDA


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.

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TSA Announces New Policies for Lighters and Breast Milk Print