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Kids Newsletter
February 25, 2008


In This Issue
• Many Babies Exposed to Chemicals
• Cold Meds Not Safe for Kids Under 2, FDA Warns
• Youth Suicide Warnings Are Slowing Antidepressant Sales
• Body Abnormalities, Childhood Cancer May Share Genes
 

Many Babies Exposed to Chemicals


MONDAY, Feb. 4 (HealthDay News) -- More than 80 percent of infants tested in a new study had been exposed to a potentially harmful group of chemicals known as phthalates.

Exactly what this means in terms of infant health isn't yet clear, however. Some animal studies have found these substances to be harmful to development, and one study on human infants found an association between exposure to a particular phthalate and male reproductive problems. Because the exact effects on the developing body aren't known, the researchers suggest limiting the use of products that contain these chemicals in infants as much as possible. Baby lotion, baby shampoo and baby powder were all linked to phthalate exposure in the study.

"Right now, we still don't know the true long-term effects," said study author Dr. Sheela Sathyanarayana, an acting assistant professor in the department of pediatrics at the University of Washington, Seattle. But, she added, it's probably a good idea to "decrease the amounts of products used, especially in newborns."

Phthalates are a group of widely used chemicals that make plastic softer and help stabilize fragrance in personal care products. These chemicals are found in children's toys, infant care products, cosmetics, food packaging, vinyl flooring, blood storage containers and more, according to the U.S. Centers for Disease Control and Prevention (CDC). Exposure to phthalates occurs when you use a product containing them, from breathing household dust containing phthalates, from medical treatments like dialysis that use products with phthalates, and from living near a manufacturing facility that uses phthalates, according to the CDC. Phthalates are banned from use in personal care products and in some toys in Europe.

For the current study, the researchers looked for nine different metabolites of phthalates in the urine of 163 infants born between 2000 and 2005. The reason they had to look for evidence of phthalate exposure in the urine is that it's difficult to measure exposure any other way because manufacturers aren't required to disclose all phthalates in their products.

"Right now, manufacturers aren't required to label them, so it's difficult to know if you're using a product with phthalates," explained Sathyanarayana.

Most of the infants studied -- 81 percent -- had detectable levels of phthalate metabolites. Because the researchers also asked the parents about which products had been used on the babies, they were also able to see an association between higher levels of phthalate metabolites and the use of baby shampoo, lotion and powder. Diaper creams and baby wipes didn't appear to increase the concentration of phthalate metabolites in the urine, according to Sathyanarayana.

Findings from the study are published in the February issue of Pediatrics.

"We believe that there is potential value in the study of metabolized phthalates. But we take great exception to any effort to draw unfounded conclusions that suggest human health risks are associated with the mere presence of very low levels of metabolized phthalates in urine," Marian Stanley, manager of the Phthalates Esters Panel of the American Chemistry Council, a plastics industry trade group, said in a statement.

"With phthalates in particular, there's good research in multiple animal studies that these compounds can be harmful. It's interesting that industry is willing to accept animal studies to introduce new medication, but when something is found to be harmful, industry says, 'Well, those studies were just done on rats,' " said Dr. Jonathan Weinkle, a physician at Children's Hospital of Pittsburgh and the University of Pittsburgh's Cancer Institute's Center for Environmental Oncology. "If animals are useful models for things that are helpful, it's because their bodies are similar enough to ours. Animal models should be reliable for good and bad."

Both Weinkle and Sathyanarayana said that dose makes a difference. The greater the exposure, the greater potential for harm, which is why they recommend limiting the use of products containing phthalates if possible. Sathyanarayana said that phthalates are often contained in fragrances, so a product that's fragrance-free may also be phthalate-free, and she said there are products available that are labeled phthalate-free, but they're generally more expensive.

More information

The Environmental Working Group has a database of personal care products  External Links Disclaimer Logo, including baby-care products, that evaluates whether individual products are likely to be safe.


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Cold Meds Not Safe for Kids Under 2, FDA Warns


THURSDAY, Jan. 17 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday issued a public health advisory stating that over-the-counter cough and cold medicines should not be given to infants and children under the age of 2.

Although concern about the safety of these medications when used in the very young has been widely aired in recent months, FDA officials said they were concerned the public wasn't getting the message.

"We strongly recommend that over-the-counter cough and cold products should not be used in young children under 2, because serious and potentially life-threatening side effects can occur from use of these products," Dr. Charles Ganley, director of the FDA's Office of Nonprescription Products, said during a morning news conference. "We have not come to a final decision on the use of cough and cold products in children aged 2 to 11 and continue to work within [the] FDA to arrive at a decision."

"We were concerned that parents would continue to use these products in children under 2, even with all the publicity," Ganley added.

"The public health advisory from the FDA is definitely a good thing," said Catherine Tom-Revzon, clinical pediatric pharmacy manager at Children's Hospital, Montefiore Medical Center, in New York City. "A lot of health-care professionals, including myself, have always taken the approach of not giving medication to children where there isn't enough evidence to show that it's safe and actually works. This actually supports that idea, so it gives more credibility when we speak to patients about this."

"I'm a parent of a toddler myself, and my daughter has had multiple colds, and it is difficult to watch and not do anything," she noted. "Now, parents are being told that they can't give medication. It's probably going to be difficult for them to accept, but the reality is it's better to be safe by not giving medication that could potentially harm young children. It's the right thing to do."

Last November, the FDA became aware of a number of surveys that indicated that individuals or parents were continuing to use the products without getting advice from a health-care provider.

The medicines, which include decongestants, expectorants, antihistamines and cough suppressants, have been associated with different rare but serious events including convulsions, rapid heart rates, decreased levels of consciousness, and even death.

A review of records filed with the FDA between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine. Most of the deaths involved children younger than 2.

The current advisory is based on an agency review of data and recommendations discussed during a joint meeting of the Nonprescription Drugs and Pediatric Advisory committees last October. The committees recommended a ban on cold medicines in children under the age of 2.

Right before the meeting, makers of dozens of cough and cold remedies targeted to infants voluntary recalled these products. In particular, products with pictures of infants on the label or use of the word "infant" in the name were taken off shelves. Overall, there are approximately 800 popular cough and cold medicines sold in the United States. Experts estimate that Americans spend about $2 billion annually on these types of medications.

An internal working group at the FDA was not able to come to a consensus as to recommendations for children aged 2 to 11. A decision on this issue is expected by the spring.

Dr. Lisa Mathis, associate director of the FDA's Office of New Drugs, Pediatric and Maternal Health Staff, had this advice for those caring for children over the age of 2:

  • Always remember that these medications do not cure colds, they don't shorten the time the child has the cold and are only meant to help a child's symptoms.
  • If you choose to give medication, look at the active ingredients' section of the label and what symptoms each active ingredient is intended to treat.
  • Be very careful in giving more than one over-the-counter cough and cold medication to your child. Remember that many OTC cough and cold products have multiple medications in them. If you use two medications with similar active ingredients, this could hurt a child.
  • Make sure to carefully follow directions on the label.
  • Only use the dropper or cup that comes with the medicines, not household measuring devices.
  • If you have the opportunity to use cough and cold medicines with childproof safety caps, you should do so.
  • Store all medicines out of the reach of children.
  • Call your physician or pharmacist or other health provider if you have any questions regarding the use of these medications in children 2 years or older.

"We're not trying to dictate the practice of medicine. We understand that health providers on an individual basis have to make certain decisions based on the facts presented to them, but we do need to recognize that there have been reports of serious adverse events in the less-than-2 age group related to misdosing and in attempting to choose the correct product," Ganley said. "Clearly, there have been instances where more than one product was used or it was not clear to the parent as to what the ingredients are in the products."

More information

Visit the U.S. Food and Drug Administration for more on the advisory.


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Youth Suicide Warnings Are Slowing Antidepressant Sales


MONDAY, Jan. 7 (HealthDay News) -- Warnings about the risk of suicidal thoughts and behaviors in young people who take antidepressants may be slowing the pace of antidepressant prescriptions, new research suggests.

The U.S. Food and Drug Administration first became aware of the possibility that antidepressants and selective serotonin reuptake inhibitors (SSRIs) might increase the risk of thoughts of suicide and suicidal behavior in children and adults in the early 1990s. By October 2004, the FDA had issued a general warning about the increased risk for youths taking antidepressants.

Researchers at Columbia University Medical Center, New York, evaluated trends in prescriptions for antidepressants using data from Medco, a company that manages prescription drug benefits. They looked at antidepressant prescriptions by age: youth age 6 to 17; adults age 18 to 64; and seniors over age 65. They then compared prescription data by age group for three time periods: before the warnings were issued (May 1, 2002 to June 19, 2003); the warning specific to medications such as Paxil, which contains the SSRI paroxetine (June 20, 2003, to Oct. 15, 2004); and the universal or black box warning (Oct. 16, 2004, to Dec. 31, 2005).

The researchers found that the paroxetine warning resulted in lower prescriptions of paroxetine for young people and, to a lesser degree, older adults, as well. Other antidepressants continued to be prescribed at their previous levels.

However, after the more general black box warning, the researchers saw a "statistically nonsignificant" reduction in the use of all antidepressants to treat youths, but a significant drop in the use of all SSRIs in addition to paroxetine.

The researchers noted that between 1985 and 1990, antidepressant prescriptions quadrupled. The recent warnings have moderately slowed the use of antidepressant prescriptions, particularly for young people, concluded the researchers.

The study was published in the January issue of Archives of General Psychiatry.

More information

To learn more about the treatment options available to people with mental illness, visit the National Institutes of Health.


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Body Abnormalities, Childhood Cancer May Share Genes


THURSDAY, Jan. 3 (HealthDay News) -- Dutch scientists have discovered that children who have cancer also have more body anomalies, such as asymmetric limbs and curvature of the spine.

This suggests that the same genetic defect underlies both the cancer and the anomaly, raising hopes that genetic information may help identify individuals predisposed to develop cancer.

"This is an excellent study, with very large numbers of patients, and it shows that we're beginning to understand that there are certain genetic changes that predispose individuals to developing various cancers," said Dr. Jay Brooks, chairman of hematology/oncology at Ochsner Health System in Baton Rouge, La.

"The good news in childhood cancer is that many of them are highly curable," said Brooks. Hopefully we'll be able to use the information in this study to better follow patients who have a genetic predisposition and be able to diagnose cancers sooner."

Another expert agreed.

"The authors have identified many anomalies that are more likely to be found in a group of children with cancer. Any child with cancer and an anomaly deserves a complete genetic evaluation," said Dr. Stephanie Sacharow, a medical geneticist at the University of Miami Miller School of Medicine.

The study, led by Dr. Johannes Merks of the Academic Medical Center in Amsterdam, was published in the Jan. 2 issue of the Journal of the American Medical Association.

Certain genetic syndromes have already been linked with an increased risk for developing childhood cancer.

For instance, Gorlin syndrome (characterized by a broad face and possibly organ deformities) is linked with an increased risk for basal cell carcinoma. Rubinstein-Taybi syndrome (associated with certain physical features and developmental abnormalities) is linked with meningioma, or benign brain tumors.

This study involved nearly 1,100 patients: 898 long-term survivors of childhood cancers and 175 children newly diagnosed with cancer. These children were compared with more than 1,000 children who did not have cancer but who were examined for 683 physical abnormalities in the same way.

Children who had cancer also had more major and minor abnormalities, such as uneven limbs, broad hands or feet, prominent ears and curvature of the spine.

Just under 27 percent of cancer patients had one or more major abnormalities, compared with 15.5 percent of controls. There were two or more abnormalities present in 5.1 percent of patients versus 1.6 percent of controls; while three or more abnormalities were found in 0.9 percent of patients and no controls.

One or more minor anomalies were present in 65.1 percent of patients versus 56.2 percent of controls; two or more minor abnormalities were present in 32.8 percent of patients versus 22.1 percent of controls; while three or more such abnormalities were found in 15.2 percent of patients compared with 8.3 percent of controls.

Almost 4 percent of cancer patients had a clinical genetic syndrome and 14 different abnormalities were significantly linked with childhood cancer.

The mean ages of the two groups of participants were widely divergent, with cancer patients at 21.2 years and controls at 10.4 years, but the authors stated that they only looked at abnormalities that were not associated with a particular age.

All participants were white, eliminating the possibility that ethnicity influenced the prevalence of different cancers or different abnormalities.

"The importance of this is not necessarily in the clinical practice but rather in the fact that as we put this information together, you can then eventually link the actual genes that are involved in producing a particular abnormality and that -- in the long run, not in the short run -- may be quite significant in looking at the potential for explanation and eventually cure," noted Dr. Ludovico Guarini, director of pediatric hematology/oncology at Maimonides Cancer Center in New York City.

The subject of diagnosis and identification of high-risk individuals is trickier, he added.

"Gene mutations which are associated with cancer can give you a hint and sometimes even a solid lead, but they by no means identify the individuals who will develop cancer. They will identify individuals who are somewhat at increased risk," Guarini said.

More information

There's more on childhood cancer at the U.S. National Cancer Institute.


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