Thursday, June 30, 2011

Loratadine and Desloratadine Use in Children

From Pediatric Pharmacotherapy

Marcia L. Buck, Pharm.D., FCCP, FPPAG
Posted: 06/17/2011; Pediatr Pharm. 2011;17(5) © 2011 Children's Medical Center, University of Virginia  for full article
Introduction Loratadine is one of the most widely used antihistamines in the United States. Introduced on April 12, 1993 as a prescription medication for the treatment of perennial or seasonal allergic rhinitis and chronic idiopathic urticaria, it is now available without a prescription or "over the counter" (OTC) in a wide variety of formulations.
Desloratadine, the single active isomer of loratadine, was approved by the Food and Drug Administration (FDA) on December 21, 2001 and still requires a prescription.
Both versions are approved for pediatric use:
loratadine for children as young as 2 years of age and desloratadine for infants 6 months of age and older.
This issue of Pediatric Pharmacotherapy will provide a brief review of loratadine and desloratadine, focusing on studies supporting their use in the pediatric population.
Contraindications and Precautions
Loratadine and desloratadine are contraindicated in patients with a known sensitivity to either drug or the excipients used in the formulations available.
Hypersensitivity reactions are rare, but include rash, urticaria, pruritus, dyspnea, edema, and anaphylaxis.
Although some earlier second-generation antihistamines (astemizole, terfenadine) have been associated with prolongation of the QTc interval and a risk for torsades de pointes, multiple studies have shown no effect on ECG parameters by loratadine or desloratadine.
Drug Interactions
Drugs that inhibit the activity of CYP3A4, such as erythromycin, cimetidine, and ketoconazole, prolong the metabolism of loratadine and desloratadine. As a result, plasma concentrations may increase significantly. Administration of ketoconazole 200 mg every 12 hours produced a 307% increase in loratadine plasma concentrations, measured as the area under the concentration-time curve over 24 hours, and a 39% increase in desloratadine concentrations. In spite of the increase in plasma concentrations, studies conducted in healthy adult volunteers have not revealed a change in vital signs, electrocardiographic measurements of the QTc interval, laboratory tests, or other adverse effects.
Azithromycin and fluoxetine may also increase loratadine or desloratadine concentrations, but to a lesser degree.


Loratadine and desloratadine are effective therapies for the management of seasonal or perennial allergic rhinitis and urticaria in infants, children, and adults. As with other second generation antihistamines, their decreased potential for causing sedation compared to older agents, make loratadine and desloratadine first-line therapies for pediatric patients with allergies.

Playing It Safe This Summer, Pediatric Sports Injuries

Almost one third of all childhood injuries are sports-related. Children between 5 and 14 years of age account for nearly 40% of all sports-related injuries treated in hospital emergency departments and the injury severity increases with age.
Sixty percent of organized sports-related injuries occur during practice.
About 20% of children and adolescents playing organized sports are injured each year and 1 in 4 of these injuries is considered serious.
The most common sport-related injuries in children are sprains and strains, bone and growth plate injuries, repetitive motion injuries, concussions and heat-related illness.
The x-ray shown reveals a Salter-Harris type III fracture of the medial malleolus of the left ankle, note that the fracture line is in the epiphysis and does not cross the growth plate. The red arrow demonstrates the fracture line while the blue arrow reveals the growth plate (physis).

 Approximately 2 out of 5 traumatic brain injuries among children are associated with participation in sports and recreational activities.
Traumatic brain injury is the leading cause of sports-related death in children, the majority of which occur during bicycling, skateboarding, or skating incidents.
Most (80-90%) traumatic brain injuries are mild. These mild traumatic brain injuries are called concussions. Concussions are functional, not structural, injuries and no abnormality is seen on CT scan or MRI.
A brain contusion is a more serious injury associated with localized structural damage and bleeding, often from multiple hemorrhages, which are readily apparent on CT scans (arrows). They are most commonly found in the frontal and temporal lobes.

A concussion or mild traumatic brain injury is a transient alteration of mental status induced by traumatic biomechanical force, with or without loss of consciousness. Every year athletes sustain concussions playing sports, with football having the highest prevalence. There are over 40,000 concussions suffered every year among high school players.
Brain damage caused by concussions can have long-term effects.
Symptoms of concussion are many. The most common symptoms in adolescent males are headache, dizziness/unsteadiness, confusion/disorientation, concentration difficulty and amnesia. In adolescent females common symptoms include headache, dizziness/unsteadiness, concentration difficulty, confusion/disorientation and drowsiness. Diagnosis is clinical as routine imaging studies of the brain such as CT and MRI (shown) are typically normal.
for more:

What Is New About Car Safety Seat Recommendations?

From CHOP Expert Commentary

Flaura K. Winston, MD, PhD

Hello, I'm Dr. Flaura Koplin-Winston. I'm a general pediatrician, a biomechanical engineer, and I co-direct The Center for Injury Research and Prevention at The Children's Hospital of Philadelphia.
On March 21, 2011, the American Academy of Pediatrics released new guidelines on child passenger safety, based on up-to-date information. These created lots of buzz among parents and physicians. In this podcast, I'll review the recommendations with you and simplify them. In a subsequent podcast, I'll tell you how to use these recommendations when giving guidance to your families.
The common theme that underlies the recommendation is: don't rush the transition.
Every time a parent moves a child from one stage to the next, like rear-facing to forward-facing, they reduce the safety benefits.
Parents are excited when their children reach developmental milestones and want to push them on to the next step. But, safety often requires us to hold back.
So, here's a practical tip. When reviewing child development, make sure to applaud the developmental milestones that are reached and encourage parents to move those kids along, but caution them not to do that with safety, particularly child passenger safety.
In case you haven't had the chance to read the recommendations, let me tell you what's new. What we're doing is just becoming clearer with the recommendations.
Here are the major differences. In the past, we used to say to families: keep children rear-facing until at least 1 year of age and 20 pounds. Now, we're actually going to change that.
What you should be saying is: keep them rear-facing until at least 2 years of age or the upper height and weight limit that the manufacturer specifies for that seat.

Similarly, with forward-facing seats, instead of telling families to keep the child forward-facing until age 4 years or a weight of 40 pounds, tell them to keep that child in a seat forward-facing with the 5-point harness until the child is at least the upper weight limit of that seat, which is often higher than 4 years or 40 pounds.

For booster seats, many clinicians will recommend keeping the child in the booster seat until age 8 years.

The fact is that the seatbelt doesn't fit well until the child is a minimum height of 4 feet, 9 inches. What we should be saying to families is: keep the child in a booster seat until at least 4 feet, 9 inches and that usually is reached around age 8-12 years, at which point a child should go in a 3-point restraint.
There's no change to the backseat recommendation.
Children should stay in the back until age 13 years.
So, the general progression hasn't changed. The new report just recommends keeping the children in each of these steps longer.
Here's a practical tip. The American Academy of Pediatrics produced this very helpful algorithm to help you figure out, based on a child's age, height, and weight, the right restraint for the child. Print it out, keep it in your office. It will help you give advice to families.
What I really want to assure you is that you do not have to be a child passenger safety expert. You just need to be familiar with the guidelines and, when families have questions, know where to send them.
There are 2 places. You can send them to our Website, where you will find lots of information in English and Spanish for families.
The other is or 1-866-SEAT-CHECK for families wishing to locate a car seat technician.
In the second Webcast, I will give you some guidance on how to help families with these guidelines and how to answer those questions.

AAP Guidelines Address Youth, Obesity, and the Media

From Medscape Medical News

Laurie Barclay, MD

June 29, 2011 — At every well-child visit, pediatricians should ask about daily screen time and whether the child's bedroom has a television (TV) or Internet connection, according to an American Academy of Pediatrics (AAP) policy statement reported online June 27 in Pediatrics.

"Obesity has become a worldwide public health problem," write Victor C. Strasburger, MD, and colleagues from the 2010-2011 AAP Council on Communications and Media. "Considerable research has shown that the media contribute to the development of child and adolescent obesity, although the exact mechanism remains unclear. Screen time may displace more active pursuits, advertising of junk food and fast food increases children's requests for those particular foods and products, snacking increases while watching TV or movies, and late-night screen time may interfere with getting adequate amounts of sleep, which is a known risk factor for obesity."

The effect of TV viewing on children's weight status appears to be intensified by having a TV set in the child's bedroom. In a study of 2343 children aged 9 to 12 years, the presence of a TV set in the child's bedroom was a significant risk factor for obesity, independent of physical activity levels. Another cross-sectional study showed that 1- to 5-year-olds who had a bedroom TV were more likely to be overweight or obese. Compared with teenagers who did not have a bedroom TV, those who did spent more time on TV viewing and less time on physical activity. They also ate fewer family meals and fewer vegetables and drank more sweetened beverages.

Other harmful effects of TV and other media include disruption of sleep patterns. In a longitudinal study of adolescents in New York, those who watched 3 or more hours/day of TV had double the risk for difficulty falling asleep compared with those who watched TV less than 1 hour/day. Sleep displaced by TV or media viewing may also be associated with increased risk for obesity.

Sleep loss may increase snacking and consumption of less healthy foods to maintain energy; it may cause fatigue, and therefore increase sedentary behavior; and it may also have direct metabolic consequences.
AAP Recommendations
Specific AAP recommendations regarding dealing with media use as a risk factor for youth obesity include the following:
  • As recommended in Bright Futures guidelines, every well-child visit should include asking parents and patients 2 key questions about media use: How much time does the child or teenager spend with screen media per day? Is there a TV set or unrestricted, unmonitored Internet connection in the child's bedroom or throughout the house?
  • Pediatricians should encourage parents to monitor their child's TV viewing, to educate their child regarding good nutrition, and to discuss food commercials with their child.
  • Pediatricians should advise parents to limit total noneducational screen time to 2 or fewer hours/day, to refrain from placing TV sets and Internet connections in their child's bedroom, to coview with their children, to facilitate good sleep habits by limiting use of screen media at night, and to avoid screen exposure for infants younger than 2 years.
  • Pediatricians should collaborate with community groups and schools to conduct media education programs in childcare centers, schools, and community-based institutions such as the YMCA. These programs should teach children how to understand and interpret commercials and should teach parents about limiting overall media use.
  • Pediatricians should collaborate with their state chapters, the AAP, parent and public health organizations, and the federal government to petition Congress, the Federal Trade Commission, and the Federal Communications Commission to ban junk food advertising during programming viewed mostly by young children. They should also advocate for bans on interactive advertising involving junk food or fast food to children via digital TV, cellular telephones, and other media, and for bans on payments for product placement in movies.
  • Pediatricians should ask Congress to fund media research on the interaction of heavy media use in children with stress in the home or other psychosocial elements of the child's life. Other research topics should include the role of new media technologies in increasing advertising exposure or encouraging more sedentary behavior, the relative effects of these mechanisms on obesity, and how to counteract these effects.
  • Pediatricians should advocate for more counteradvertising and more prosocial video games and Web sites encouraging children to choose healthy foods.
  • Pediatricians should realize that children with high levels of screen time have increased childhood stress, which increases their risk for stress-associated conditions including mood disorders, substance abuse, diabetes, cardiovascular disease, and asthma. Replacing screen time with more prosocial or resilience-building activities, such as exercise and imaginative or social play, may therefore help prevent or ameliorate a wide range of conditions in addition to obesity.
"Media clearly play an important role in the current epidemic of childhood and adolescent obesity," the authors conclude. "The sheer number of advertisements that children and adolescents see for junk food and fast food have an effect. So, too, does the shift away from good nutritional practices that increased media screen time seems to create. Any success in dealing with the current epidemic will require a major change in society's recognition of media exposure as a major risk factor for obesity and in young people's media habits and the advertisements to which they are exposed."
Pediatrics. Published online June 27, 2011. Full text

Thursday, June 23, 2011

Group Concludes That Cell Phones Are Possibly Carcinogenic

Medscape Medical News > Oncology

Roxanne Nelson

June 23, 2011 — Key conclusions that led to the recent announcement from the International Agency for Research on Cancer (IARC) that cell phones are "possibly carcinogenic" have now been published.
A paper published online June 22, ahead of the full report, in the Lancet Oncology summarizes the key findings from a meeting of 31 scientists organized by the IARC in Lyon, France, who considered the potential carcinogenic hazards from exposure to radiofrequency (RF) electromagnetic fields (EMFs) emitted by devices such as cell phones.

On the basis of their assessment and evaluation of the published literature, the IARC working group concluded that RF-EMFs, including those emitted by cell phones, should be considered to be "possibly carcinogenic" to humans (division 2B in the IARC classification).
The IARC working group reached their conclusion on the basis of several studies, including the results of the large INTERPHONE international case–control study and a pooled analysis of a series of Swedish studies.
Not Completely Safe  
What 'possible' means is that it's not completely safe.
What "possible" means is that it's not completely safe, said working group chair Jonathan Samet, MD. "It obviously needs to be more clearly defined through better investigations," he explained in an interview.
Dr. Samet, who is the Flora L. Thornton Chair of the Department of Preventive Medicine at the Keck School of Medicine, University of Southern California, Los Angeles, pointed out that for right now, this is a precautionary discussion.
Patients are going to be asking their physicians about cell phone safety and if there really is an associated risk for cancer. "If patients ask, the important message is that there is a possibility of risk," Dr. Samet told Medscape Medical News.
"If anyone asks what they can do to reduce the risk, it is important to emphasize that the answers are not yet in," he said. "But if they do want to do something, there are easy steps to take to lower exposure, such as using hands-free devices and reducing use of the phone."
This may be particularly important for children, who will be using these devices for a very long time, he noted. "So consideration of exposure reduction is a reasonable strategy."
Inconsistent Results
Human exposure to RF-EMF (frequency range, 30 kHz to 300 GHz) can occur from a wide range of personal devices and occupational sources. In particular, when a cell phone is held close to the ear to make a voice call, the result can be high specific RF energy absorption-rate values in the brain, note the authors.
The specific absorption rate depends on a number of factors, including the design, the position of the phone and its antenna in relation to the head, how the phone is held, the anatomy of the head, and the quality of the link between the base station and the phone.
Of particular concern is the use of these devices by children, in whom the average RF energy deposition in the brain is twice as high as in adults; in the bone marrow of the skull, it is up to 10 times as high.
The epidemiologic evidence for an association between RF-EMF and cancer is derived from cohort, case–control, and time-trend studies; wireless (cell and cordless) telephones are the most extensively studied exposure source. The conclusion that RF-EMF is possibly carcinogenic to humans was based on the results from several studies that examined the relation between cell phone use and malignant tumors.

The INTERPHONE study (Int J Epidemiol. 2010;39:675-694), a multicenter case–control study — the largest investigation of its kind to date — found that using a cell phone appeared to slightly lower the risk of developing a glioma, compared with never using one.
But when the highest 10% of cell phone users in terms of call time were analyzed, this subgroup had a 40% increased risk for glioma, compared with those who had never used a cell phone.
The results suggest that there is an increased risk for ipsilateral tumors (those on the same side of the brain as cell phone exposure) and for tumors in the temporal lobe, where RF exposure is highest.

Associations between glioma and cumulative specific energy absorbed at the tumor location were examined in the INTERPHONE study in a subset of 553 patients for whom estimated RF doses were available. For those who used a cell phone for 7 years or more before diagnosis, the odds ratio for developing a glioma rose with increasing RF exposure. Conversely, for those who used a cell phone for less than 7 years prior to diagnosis, there was no association with RF exposure.

The working group also evaluated a pooled analysis of Swedish studies (Int J Oncol. 2011;38:1465-1474), which examined the association between cell and cordless phone use and glioma, acoustic neuroma, and meningioma. For people who had used a cell phone for more than 1 year, the risk for gliomas was 1.3 times higher (30%) than that in people who had never used a cell phone.
This risk increased as time since first use increased, and with total call time. After more than 2000 hours of use, the risk was 3.2 times as high, and ipsilateral use of the cell phone was associated with more risk. Similar findings were observed for cordless phones.

The working group notes that even though the INTERPHONE study and the Swedish pooled analysis are susceptible to bias because of "recall error and selection for participation," they still conclude that the "findings could not be dismissed as reflecting bias alone, and that a causal interpretation between [cell] phone RF-EMF exposure and glioma is possible."
The INTERPHONE and the Swedish series reached somewhat different results. "The INTERPHONE study was complicated because it was a multicenter trial, and response rates weren't as good as in the Swedish studies," explained Dr. Samet. However, "the investigators did a good job of showing what biases affected their study."
Limited Evidence
Two large studies are not enough.
Dr. Samet added that there was some evidence in the INTERPHONE study that there might be a cancer risk in longer-term users, "but it wasn't a clear signal. The Swedish studies were clearer in that respect," he said. "What it comes down to is that more research is needed — 2 large studies are not enough."
The working group also reviewed a Danish study that analyzed cancer rates and cell phone subscription from 1982 to 1995 and found no increased risk for glioma or other brain tumors among users (J Natl Cancer Inst. 2006;98:1707-1713). These findings were consistent with a number of earlier and smaller case–control studies. In addition, the working group examined more than 40 experimental studies.
Their conclusion was that there is "limited evidence in humans" for the carcinogenicity of RF-EMF, and a few members of the working group considered the current evidence in humans to be "inadequate." The reason for this opinion is that the results of the 2 case–control studies were inconsistent, there was no exposure-response relationship found in the INTERPHONE study, increases in rates of glioma or acoustic neuroma were not observed in the Danish cohort study, and, to date, time trends in incidence rates of glioma do not parallel temporal trends in cell phone use.
More and Better Research Needed
Not only are more studies needed, but the studies need to be better designed, explained Dr. Samet. "Doing this kind of case–control study, which relies on recall, is not the best way to go," he said. "We need prospective studies where we are actually tracking use with links to company records. We need large enough studies of that kind."
The Cohort Study on Mobile Communications (COSMOS) is attempting to do just that, he explained. It is the largest study to date, and will examine the effects of cell phone use on long-term health. COSMOS will attempt to track at least 250,000 people in 5 European countries for up to 30 years. Unlike previous studies, it will not rely on recall; instead, the study will follow cell phone use in real time.
The authors have disclosed no relevant financial relationships.
Lancet Oncol. Published online June 22, 2011. Abstract

Skin Care for Infants and Young Children: Using New Evidence to Address Common Myths

Sherrill J. Rudy, MSN, RN, CRNP
Posted: 06/20/2011
 For a long time, we have considered the barrier function of full-term infants’ skin equivalent to adults. However, there also is the perception that baby skin is soft, delicate, sensitive, fragile, and in need of special care. Which perspective is really true?

Both views to some extent are true. The skin of a full-term newborn has remarkable structural and functional competence at birth and does approach adult skin after a period of adjustment to the dry, extra-uterine environment.
However, recent closer examination of the skin in healthy infants and young children through noninvasive methods for studying the skin microstructure in vivo has revealed differences from adult skin.
Just like many other organ systems in infants, skin development in children continues during the early years of life, and with certain skin structures such as sebaceous glands, does not reach full adult function until adolescence.
Important for pediatric health care providers to understand are the implications that the structural and functional difference in the skin of infants and young children have for skin care recommendations in this population. Important implications of these differences include:
  • Infants and young children are at greater risk for disruption of the barrier function, toxicity, and development of contact irritation or allergy because:
    • Water handling properties differ—infant skin has higher water content, and it absorbs and loses water faster
    • Infant skin has significantly lower amounts of natural moisturizing factor (NMF) in the stratum
    • Infant stratum corneum is thinner (on average 30% thinner), and the infant suprapapillary epidermis is on average 20% thinner
    • Infant corneocytes and granular layer keratinocytes are smaller possibly due to high cell turnover rates
  • Newborns lack the acid mantle, which is formed during the first month of life. This is important for the barrier function of the stratum corneum by stabilizing intercellular lipids and retaining skin hydration as well as control of microbial colonization on the skin surface. Water, soaps, and some cleansers can disrupt this mantle in infants and young children making it more alkaline and potentially altering skin microflora, increasing TEWL, all resulting in the loss of effective barrier function
  • Delayed full functioning of melanocytes, thinner stratum corneum, and smaller skin cells all place infants and young children at enhanced risk of skin damage from UV light exposure, It is believed that the groundwork for later skin cancer is laid in childhood
Babies and young children get dirty, like to be outside, crawl on the ground, wear diapers, and are messy eaters! Adequate skin cleansing and protection is vital for their good health. Skin care in this population must take into consideration the unique properties of their skin. Fortunately, new evidence regarding differences between infant and adult skin can help guide our recommendations to parents regarding skin care for their children.
What is the best way to clean a child’s skin? I have often read and heard that bathing in water only is the safest as well as an effective way to cleanse the skin of infants and young children. Is this true?
Washing the skin with water alone provides insufficient cleansing and removal of unwanted material such as fecal enzymes, urine components, and other water-insoluble skin surface impurities.
The alkaline pH of water has been demonstrated to increase to skin surface pH for extended periods of time after exposure. Water that has high mineral content can impair skin barrier function while not adequately cleaning the skin. A note of caution here is necessary. Not all methods of cleansing the skin are alike.
Soaps, detergents, and some cleansers can also temporarily raise skin pH and be quite irritating and drying. Fortunately, new skin cleanser technology has produced cleansers that have less total surfactant and larger micelles with a pH below 7.0 for less aggressive but effective cleansing. These types of skin cleanser are available as liquids (gels and body wash) and not as solid bars. They also tend to foam less when applied to the skin.
Skin cleansers for use in infants and young children with these qualities along with minimal dyes and fragrances will provide safe, mild, gentle, effective cleansing.
Application of a moisturizing cream immediately after bathing to areas of the skin that tend to be dry or inflamed may also enhance the skin barrier function.
A study out of Germany that tested the impact of various skin care regimens on the skin barrier function of healthy full-term neonates demonstrated that bathing with a pH 5.5 wash gel followed by skin cream application showed lower transepidermal water loss and greater hydration of the stratum corneum than did bathing with water alone or bathing with wash gel.
They also demonstrated that neither the use of the wash gel or the cream delayed the development of the skin acid mantle during the first 8 weeks of life.
Should children be bathed daily?
How often a child should bathe varies a great deal depending on circumstances.
The frequency of bathing needs to take into account the child's’ age, the weather, and what they are exposed to from the environment.
For very young infants, bathing every 2–3 days is quite adequate along with spot cleansing as needed though out the day for the diaper area, face, hands, and neck folds.
(for tropical climates  - this may not be adequate because of sweating  - dr tanpohtin)
Older children may need daily bathing if they have been playing outside, wearing sunscreen, or very active in public areas.
During winter months, less frequent bathing may help to reduce dry skin from lower humidity from dry indoor heating.
Long baths as well as the use of bubble baths or bath additives with dyes and perfumes should be avoided because these increase the skin pH and cause dryness and irritation.
The ideal is a 15-minute or less bath in plain bath water using a mild cleanser with a pH of 7 or less. Mild cleansers may be used for spot cleansing as well. Apply skin cream as needed for skin dryness.
I have been receiving questions from parents in my office about the safety of preservatives in skin care products for their children. How do you recommend responding to these types of questions?
Many parents express concern because of things they have read or heard related to possible human health threats from ingredients in skin care products. Claims of inadequate testing for safety and possible risks to consumers are rampant on the Internet and in popular literature. This information alleges that industry practices related to safety testing are flawed, that there is little government oversight, and that cosmetics contain cancer-causing chemicals and other toxic ingredients. As health care providers, we must be able to adequately answer their concerns with sound scientific data where available and to educate parents on how ingredients are tested and regulated.
The absence or inadequate use of preservatives in personal care products that are applied to the skin can yield them highly susceptible to contamination by bacteria and/or fungi. This is especially true for products with high water content. Oil-based products, on the other hand, are at lower risk and therefore tend to contain smaller amounts or no preservatives at all.
The microflora of the skin itself that is easily introduced into the skin care product can contaminate it. Products stored in jars where the hand is repeatedly dipped in to retrieve the contents are the most susceptible to this type of contamination. These organisms thrive and grow in the dark moist environments of skin care products if nothing is present to inhibit this growth. Common contaminating microorganisms include Pseudomonas aeruginosa, S aureus, and Candida albicans. Skin care products can also become contaminated during the manufacturing process.

Preservatives in personal care products have a safety history that encompasses thousands of products used over decades by millions of consumers. There are no documented reports linking the use of a personal care product preservative and serious human disease. Even contact allergy to these ingredients has been reported in a very small percentage of users (approximately 6% of general population has a cosmetic-related contact allergy). In contrast, the absence of preservatives is clearly associated with contaminated products and the risk of skin infection. Prior to legislation in the United States restricting the sale of contaminated products, the US FDA found that 20% of a sample of personal care products on the market was contaminated.

The cosmetic industry has the primary responsibility to ensure that all ingredients, preservatives, and co-formulants used in skin care products are safe for their intended uses. The FDA has regulatory oversight of and authority over the cosmetic industry, including the banning or restriction of ingredients for safety reasons. In addition, the Cosmetic Ingredient Review (CIR), an independent scientific review board, critically evaluates chemical ingredients used in cosmetics and publishes its findings in the peer-reviewed literature.

As with many medications and other chemicals in our environment, the adage “It is the dose that makes the poison” (Paracelsus, 16th century) is appropriate with preservatives as well. Many of the health-related allegations about cosmetic ingredients are based on the results of high-dose laboratory testing in animals, not human testing. The ideal is to use the lowest concentrations of preservatives that provide the desired result, thereby reducing exposure. The safety and efficacy of multiple preservatives in combination each in low concentration over single preservatives in higher concentrations is well documented. Researchers are continually working to develop even safer preservative systems.
With the current evidence available to us, the benefit of using preservatives appears to outweigh any potential risks. However, we must remember that there are very few certainties in medicine. The cosmetic industry needs to be encouraged to publish more toxicity studies and safety evaluations and use the lowest concentrations of preservatives needed for efficacy. The longer preservatives are used without ill effects, the more confident we can be that preservatives are indeed safe.
Is there such a thing as a healthy tan?
A tan in actuality is a sign of skin damage. When the skin is exposed to UV light, the UV rays affect the DNA of epidermal cells and dermal fibroblasts, resulting in genotoxic and oxidative effects. In response, a protective mechanism in the skin is called into action where the existing melanin in the skin oxidizes and melanocytes produce new melanin, resulting in tan. The level of susceptibility will vary depending on the child’s skin type and how quickly they sunburn as well as how easily they tan. Children are even more susceptible than adults to this DNA-damaging effect due to lower levels of protective melanin present in the skin (melanocytes do not become fully functional until into the 2nd year of life), a thinner stratum corneum, and a higher surface area:body mass ratio.
A recent study out of England looked at healthy Caucasian babies suggesting that UVR-induced skin changes and associated photodamage can begin as early as the first summer of life before melanocytes have become fully functional. Additionally, it is believed that prior to the age of 18 years, children receive much of their lifetime-accumulated sun exposure. Chronic UV light exposure is associated with nonmelanoma skin cancer and head/neck melanomas. Several epidemiologic studies also suggest that the skin of young children may be especially vulnerable to early intense UV light exposure that leads to blistering sunburns and has been associated with trunk melanomas.
Increasingly, the skin is being recognized as playing an important role in the body’s immune response. Exposure to UV light can modulate this immune response and result in a level of immunosuppression. Transgenic mice studies have demonstrated that exposure to solar-simulated radiation in the neonatal period can reduce epidermal Langerhans cells and potentially compromise skin immune system development. Whether infants and young children are similarly susceptible is not clear at this point, but further study is definitely needed in this area.
What advice should I be giving parents regarding sun protection for their children?
We have made progress in educating the public about sun exposure risks. However, sun protection practices for children still remain suboptimal. On any summer weekend in the United States, 7% to 13% of American children become sunburned, and the incidence for the summer season ranges from 29% to 83%. Remember that children of any skin type can sunburn if the UV light dose is high enough. Recommendations for sun protection are available from the AAP, American Academy of Dermatology (AAD), and the American Cancer Society (ACS) and they include:
  • Sun avoidance: Avoiding suntanning and sunburn is especially necessary for infants less than 6 months of age. Keep babies away from direct sun exposure. For older infants and young children, time outdoor activities to avoid periods of peak sun exposure. Use lightweight but tightly woven clothing and hats to cover skin, and provide shaded play areas. Extra caution should also be used around reflective surfaces such as water, snow, and sand that can reflect up to 85% of the UV light
  • Apply and reapply sunscreen: In infants and young children, use sunscreens that have the lowest possibility for skin penetration, irritation, and allergy. Since babies often rub their eyes and put their hands in their mouths, exposure through this route must also be considered. For children 6 months of age and younger, the AAP recommends sun avoidance but states that sunscreen may be applied to small areas of skin uncovered by clothing and hats
Studies have demonstrated that sunscreens containing only nano-scale titanium dioxide and/or zinc oxide filters do not penetrate beyond the stratum corneum in adult or infant skin. These same sunscreens may also be the mildest to eyes and safest for oral exposure. Oil-based emulsion formulations of these inorganic sun filters seem to be the safest forms for very young children and those with particularly sensitive skin since they tend to contain fewer fillers, fragrances, photostabilizers, and preservatives.
We have made progress spreading the news that sun protection is necessary for children. However, we still have a long way to go in actually implementing these practices and establishing them as health habits.

How Does Infant Skin Differ from Adult Skin?

Peter Lio, MD
Posted: 06/20/2011

"Smooth as a baby's bottom" summarizes the popular notion of infant skin: the soft, supple, and practically flawless integument that is the unattainable objective of all cosmetic treatments. Indeed, it can be difficult to imagine what problems a pediatric dermatologist could possibly address given how perfect newborn skin appears to be. And while there are undoubtedly plenty of skin maladies that affect those at the beginning of life, even for the smoothest of bottoms, there are critical differences worth thinking about, both in health and disease. In this article, we review some of the important structural and physiologic differences between infant (defined here as the first few years of life) and adult skin. We also consider some of the clinical and practical ramifications of these distinctions using evidence whenever possible.

The functions of the skin remain essentially the same at all phases of life, including: barrier, photoprotection, thermoregulation, immune surveillance, hormonal synthesis, insensible fluid loss prevention, and sensory perception.
However, there are several important structural differences between the skin of babies and adults, differences immediately accentuated as the newborn transitions from the intrauterine environment to the outside world.

Barrier function of the skin is vital for survival for all human beings. With increasing prematurity, there is increasing barrier dysfunction with higher transepidermal water loss (TEWL) and increased percutaneous absorption of chemicals. As a result, there is greatly increased mortality in premature infants with impaired barrier function, generally due to microbial invasion. Remarkably, this can be demonstrated experimentally by application of emollients that enhance barrier function. In a randomized, controlled trial, massaging premature infants with sunflower seed oil 3 times daily resulted in a 41% reduction in sepsis and a 26% reduction in mortality.
Although the TEWL in full-term infants is generally agreed to be close to that of healthy adults, there is recent evidence that the barrier development continues during the first year of life.
Infant skin is found to have higher water content and is able to absorb more water and lose excess water faster than adult skin.
Other microstructural differences include thinner stratum corneum and papillary dermis in infant skin.

Beyond these structural points, however, several factors converge to make infants more susceptible to percutaneous toxicity.
Their high surface area-to-volume ratio, immature drug metabolism systems, and decreased subcutaneous fat stores effectively increase the absorptive area while decreasing the volume of distribution of a drug or toxin. This is compounded by the fact that once absorbed, the infants lack fully developed drug carriage and detoxification systems.
Furthermore, direct barrier injury can occur because of the increased fragility of infant skin, particularly from the removal of adhesive tapes and monitors, thus increasing local permeability.
Finally, given the estimated 20% incidence of atopic dermatitis among children, there are yet other reasons for barrier function to be impaired at baseline.
Because of these factors, it seems prudent to advise that only essential products be applied to the skin, particularly in the first several months of life.
Below the skin, in the subcutaneous fat, there are also discrepancies between mature and immature. In newborns, the subcutaneous fat is rich in the saturated oils palmitic and esteric acid. These fats have higher melting point temperatures than the increasingly unsaturated fats of adulthood; as more oleic acid becomes present, the melting point diminishes. The higher melting point means that the fat in infants can freeze more easily: approximately 64°C vs the much lower adult melting point of 14°C.
This principle is typified by "popsicle panniculitis," a fairly common form of fat necrosis in the cheeks of infants several hours after eating popsicles or ice, and the closely related equestrian panniculitis, seen after the cold exposure from riding horses, bicycling, or riding motorcycles.Subcutaneous fat necrosis of the newborn, a condition frequently associated with hypothermia, trauma, or other perinatal stressors, is a panniculitis that may also be related to the higher melting point of infant fat. Because of this limitation in infant skin, extra care must be made to avoid temperature extremes.
Bathing an infant provides important psychological benefits between parent and child.However, oddly enough, it can also provide an opportunity to damage the skin. There is evidence to suggest that washing the skin with a washcloth during the first 4 weeks of life is associated with increased TEWL and decreased stratum corneum hydration compared with simply soaking in water.
Another study found that tub bathing an infant was actually associated with an increased risk of cord infection vs no washing at all. 
 Several papers have examined the use of mild liquid cleansers vs using water alone for bathing. The consensus appears to be that a mild liquid cleanser may actually be less drying and less irritating than water alone, and that bathing should be brief (10 minutes or less) and no more than every other day with spot cleaning in between.

Photoprotection is an important function of the skin, though in the process of preventing ultraviolet (UV) sun damage to certain structures, the skin can itself accrue damage, increasing the chances of skin cancer. As for adults, sun protection is important in childhood. This topic takes special importance because the damage from UV radiation is cumulative: children spend more time doing outdoor activities, younger skin is more susceptible to damage, and UV damage in childhood may have particularly profound consequences later. It is also important to remember that infants are entirely dependent upon their caregivers to practice sun protection and are generally not able to communicate the symptoms of early sunburn.
In recent years, concerns have emerged over possible hormone-disrupting chemicals in sunscreens, such as oxybenzone.
In children, the doubly worrisome scenario of increased percutaneous absorption of chemicals and the enhanced developmental sensitivity to hormone disruption makes this topic extremely contentious.
Evidence for such absorption is fairly abundant with 1 study concluding: "...whilst limited absorption across the skin was observed for the majority of the sunscreens tested, [oxybenzone] demonstrated sufficiently high penetration to warrant further investigation of its continued application."

Evidence for hormone disruption is another issue that is well established for benzophenone-3, homosalate, 4-methyl-benzylidene camphor (4-MBC), octyl-methoxycinnamate (OMC), and octyl-dimethyl-para-aminobenzoic acid (PABA). All show estrogenicity, and studies document environmental persistence and widespread presence in the population. Unfortunately, even the mineral sunscreens such as titanium dioxide and zinc oxide are not without risk. There is evidence that the nanoparticles present in many of these mineral sunscreens can cause cellular damage. Although most studies have shown that there is minimal penetration into the skin, no studies have yet tested these particles in fragile or damaged skin. Infant skin is more fragile, and with the incidence of atopic dermatitis approaching 20% in some populations, there is a reasonably high chance that there will be areas of skin damage in some infants.

My conclusion strongly reinforces the message conveyed by the American Academy of Pediatrics: minimize the reliance on topical products in infancy by avoiding sun exposure and using sun-protective clothing whenever possible.
Skin diseases in infants and adults can vary as much as the difference in fundamentals of the skin. Even disorders that may sound familiar from experience in older patients may be distinct in infants: acne, skin infections, and nutritional dermatoses, to highlight a few.
Classical teenage acne (acne vulgaris) is well known to all of us; however, there are 2 distinct forms of acne that can affect patients in the first few years of life: neonatal acne and infantile acne. Neonatal acne is perhaps more accurately referred to as neonatal cephalic pustulosis (NCP) and can affect up to 20% of newborns.
This papulopustular disorder lacks the comedones of true acne and may actually be related to colonization with Malassezia yeast species on the skin. Generally benign and self-limited, treatment with topical ketoconazole may shorten the duration of the disease.
Infantile acne, on the other hand, is far more rare than neonatal acne, and generally occurs between 3 months and 1 year. Both comedones and inflammatory papules are seen in this disease, and like its teenage counterpart, scarring may be an issue. Sometimes infantile acne will resolve by school age without specific treatment, but it may also be a harbinger for severe forms of acne in adolescence and appears to be more common in families with a strong family history of acne. Here the differences end: treatment can be very similar to that for teenage acne, including a topical retinoid and topical benzoyl peroxide.[25]
Staphylococcal scalded-skin syndrome in infants and children is caused by staphylococcal bacteria that release exfoliative toxin and can also be seen in adults with renal failure. This suggests that it is the inability to clear the toxin that causes the characteristic superficial bullae and widespread sloughing, with crusting and impetiginization at the orifices.Prompt diagnosis and treatment with systemic antibiotics and skin barrier support are necessary to minimize morbidity from this disease.
Infants are also particularly susceptible to nutritional deficiencies, and zinc deficiency may be acquired or inherited. Acrodermatitis enteropathica (AE) is the rare, autosomal-recessive disease of impaired zinc absorption that usually presents upon weaning from breast milk. Acrodermatitis enteropathica-like eruption can be seen in the setting of insufficient dietary zinc, including breast milk deficiency. Symptoms of periorificial dermatitis, diarrhea, and hair loss frequently are mild and incomplete, making this disease a challenge to diagnose at times. Once the diagnosis is made, zinc supplementation is required, which generally results in dramatic reversal of skin lesions within several days.
Infant skin is often thought of as ideal skin, and its characteristics are frequently sought by adults. However, beyond the smooth and supple beauty, there are significant structural and functional differences that make infant skin more susceptible to certain problems. During the first years of life, there are considerable developments of the skin and subcutaneous fat that warrant handling infants differently—and much more gingerly—than adults.
source : Medscape Pediatrics 

Wednesday, June 15, 2011

Use of Botanical Supplements in Infants

From Medscape Pediatrics

An Expert Interview With Sara B. Fein, PhD

Laurie Scudder, DNP, NP

Posted: 06/03/2011

Editor's Note:
Use of dietary botanical supplements (DBS) and herbal teas by infants in the first year of life is worrisome for several reasons. 
Infants under 6 months of age should not be given anything except breast milk or formula unless recommended by a doctor (for example, vitamin or mineral supplements or medicines, including specific DBS if medically recommended.) 
Other concerns are the possibility of water intoxication in young infants and the wide variety of DBS given to infants. 
Some DBS reported as given to infants have the potential to cause side effects, including allergic reactions, or drug interactions if the infant also is taking other medications.
Infants, because of differences in their physiology and metabolism as well as, obviously, a much smaller body weight, may be more susceptible to adverse effects from DBS. 
Population-based studies of use of these products in US children have produced widely varying estimates ranging from < 1% to 5%, whereas studies in specific settings have been even higher. A survey of children participating in the special supplemental program Women, Infants, and Children (WIC) in 2 states reported a prevalence of 36%. 
The current study is the first to focus specifically on use in infants during the first year of life. Laurie Scudder DNP, NP, Clinical Editor of Medscape, spoke with Sara B. Fein, PhD, one of the study authors, to discuss the findings and the implications for clinical practice.
Medscape: Dr. Fein, could you review the impetus for this study? What factors contributed to the decision to examine the use of these agents in infants? Could you describe the specific types of products that were of interest?
Dr. Fein: The study was conducted as part of a large study of infant feeding and care practices in the United States, not because we had any prior concerns about this issue. The research was conducted in collaboration with the US Centers for Disease Control and Prevention, Office of Women's Health, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Office of Dietary Supplements in the National Institutes of Health (NIH), the National Cancer Institute, and the Maternal and Child Health Bureau in the Health Services and Resources Administration. The Economic Research Service and the Food and Nutrition Service at the US Department of Agriculture (USDA) also participated. The sample was drawn from a nationally distributed, although not necessarily representative, consumer opinion survey administered between 2005 and 2007 to approximately 3000 mothers 18 years of age and older. We examined a number of topics related to infant feeding and care. For example, we included questions about infant formula, commercial baby foods, pacifiers, breast pumps, and more. We wanted to get as complete a picture as possible about the care and feeding of US infants. We included questions about dietary botanical supplements and teas because no data from the United States existed for a large sample of the general population of infants. Other studies have looked at use in children or special populations, like children with disabilities or chronic conditions. The US Food and Drug Administration (FDA) regulates supplements, and we believe that it helps us to know which population groups are using various products.
Medscape: Could you review for us the results of this study?
Dr. Fein: To summarize, our main findings were:
  • About 9% of mothers in the sample reported giving DBS and/or teas to their infants in the first year of life, although usually only for a short period of time. This figure is much higher than a previous figure of 0.8% reported from the National Health and Nutrition Examination Survey.Other studies also found much lower use estimates of anywhere from 3.9% to 5.0%.Because our sample over represents certain groups who may use DBS or teas more often, we believe that the true national prevalence rate of infant use is somewhere between 3% and 10%.
  • The mothers reported giving infants a variety of different DBS or teas, the most common of which included gripe water, chamomile, teething tablets, and unspecified tea. The ingredients in gripe water vary by brand but usually include ginger and fennel.
  • The 4 most common reasons that mothers reported feeding DBS or teas to their infants were to help with fussiness, digestion, colic, and relaxation.
  • The percentage of mothers who used DBS or teas to treat an illness increased with infant age.
  • We found that the most commonly reported sources of information about DBS and teas were friends or relatives (30%), the media (28%), and healthcare professionals (27%).
Medscape: Were there particular populations of women who tended to use these products?
Dr. Fein: We found that mothers who fed their infants DBS or teas were more likely to have used DBS themselves. This finding is consistent with findings in previous research.
Hispanic mothers were more likely to give DBS or teas to their infants than non-Hispanic white mothers. This finding is consistent with findings in previous research. We found that longer breast-feeding, a characteristic that has not been studied, was related to giving the infant DBS or teas.
Medscape: Were there regional variations in frequency of use, products used, or the reasons cited for use of these products?
Dr. Fein: We only looked at region by prevalence of use. Mothers in the West were more likely to give their infants DBS or teas. Use of these products in the Northeast, Midwest, and South was somewhat lower and, in all 3 regions, approximately equivalent.
Medscape: Were the results surprising to you and your fellow researchers?
Dr. Fein: Because we could not find any previous studies in infants, we did not know what to expect. However, we had not anticipated that the rate of use would be this high.
We also did not expect to find the variety of products that were given to infants. In addition to gripe water, chamomile, and teething tablets, mothers reported use of mint, fennel, anise, Echinacea, catnip, ginger, baby tea, tummy soother, herbal cold remedies, and unspecified teas.
Another category included a variety of products including flaxseed oil, garlic oil, goldenseal extract, grape extract, clove oil, comfrey, and numerous other products.
Medscape: What are the implications for practicing primary care clinicians? Are there particular adverse events that could result from use of these products that might alert a clinician to specifically inquire about their use?
Dr. Fein: Healthcare providers should recognize that infants under their care may have been given 1 or more of a wide variety of DBS and teas. Some dietary supplements contain active ingredients that have biological effects on the body that could make them unsafe for specific consumers because of health, age, or the medications that they are taking.
Experts recommend that infants younger than 6 months of age be given only breast milk or formula, along with medicines and certain vitamins if needed. Therefore, giving any form of tea at a young age is against recommendations.
One reason for the recommendation is that infants are growing rapidly and need the nutrients in breast milk or formula.
Giving teas would reduce the amount of milk that the infant could drink and thereby reduce the level of nutrition that they receive.
Also, consistently giving waterlike liquids can lead to water intoxication.
Other literature has discussed possible risks to infants from DBS because of differences in physiology, metabolism, and dose per body weight -- although our study did not evaluate these issues.
Medscape: Parent education is paramount. Can you discuss some of the specific recommendations that you would make for clinicians to best educate families in their practice?
Dr. Fein: The FDA generally recommends that consumers check with their healthcare providers about the use of any dietary supplement. However, our study found that only a quarter of women reported having consulted with a healthcare professional. Given the significant number of infants likely using these products, it is important that healthcare professionals specifically ask mothers about their use.
Asking about use of these products provides an opportunity to reiterate the American Academy of Pediatrics (AAP) recommendation that infants under 6 months of age only receive breast milk or formula unless they require a dietary supplement or medicine.
Parents should be encouraged to check with their healthcare professionals before they give any DBS to their infants and should be educated about the potential for adverse effects.
However, healthcare professionals should also be aware that in some populations use of these products is very common and consistent with cultural dietary patterns. The FDA Webpage on dietary supplements contains information about a variety of specific products.
Medscape: From a public health and policy perspective, are there regulatory or legislative interventions that are now indicated?
Dr. Fein: Our study was descriptive in nature, and it will be valuable to us in designing future studies. There have been no FDA policy changes resulting from this study; however, this type of information helps the agency better understand the public health impact of the products that we regulate.