McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

Recall — Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

FOR IMMEDIATE RELEASE – April 30, 2010 – Fort Washington, PA. McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. (SEE RECALLED PRODUCT LIST BELOW).

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

Consumers can contact the company at 1-888-222-6036 and also at www.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm

For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch1.|

McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products.

PRODUCTS NDC Number

TYLENOL® INFANTS’ DROPS

CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. GRAPE FLAVOR 50580-144-01

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR* 50580-144-15

CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY DYE FREE 50580-167-01

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. CHERRY FLAVOR 50580-143-15

CONCENTRATED TYLENOL® INFANTS’ DROPS 1 OZ. CHERRY FLAVOR 50580-143-30

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE – HOSPITAL 50580-144-18

CONCENTRATED TYLENOL® INFANTS’ DROPS 0.25 OZ. GRAPE – SAMPLE 50580-144-40

CHILDREN’S TYLENOL® SUSPENSIONS

CHILDREN’S TYLENOL® SUSPENSION 2 OZ. CHERRY BLAST FLAVOR 50580-123-02

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR 50580-123-04

CHILDREN’S TYLENOL® DYE-FREE SUSPENSION 4 OZ. CHERRY FLAVOR 50580-166-04

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. GRAPE SPLASH 50580-296-04

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-407-04

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. VERY BERRY STRAWBERRY FLAVOR 50580-493-04

CHILDREN’S TYLENOL® SUSPENSION 1 OZ. CHERRY BLAST FLAVOR – SAMPLE 50580-123-01

CHILDREN’S TYLENOL® SUSPENSION 4 OZ. CHERRY BLAST FLAVOR – HOSPITAL 50580-123-03

CHILDREN’S TYLENOL® PLUS SUSPENSIONS

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & SORE THROAT CHERRY FLAVOR 50580-247-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COUGH & RUNNY NOSE CHERRY FLAVOR 50580-249-04

CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & STUFFY NOSE GRAPE FLAVOR 50580-253-04

CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. COLD & COUGH GRAPE FLAVOR 50580-254-04

CHILDREN’S TYLENOL® PLUS DYE-FREE SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-255-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. FLU BUBBLEGUM FLAVOR 50580-386-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD GRAPE FLAVOR 50580-387-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. COLD & ALLERGY BUBBLEGUM FLAVOR 50580-390-04

CHILDREN’S TYLENOL® PLUS SUSPENSION 4 OZ. MULTI-SYMPTOM COLD GRAPE FLAVOR 50580-391-04

MOTRIN® INFANTS’ DROPS

CONCENTRATED MOTRIN® INFANTS’ DROPS 1 OZ. BERRY DYE FREE 50580-198-01

CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY DYE FREE 50580-198-15

CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR* 50580-100-15

CHILDREN’S MOTRIN® SUSPENSIONS

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY DYE FREE 50580-184-04

CHILDREN’S MOTRIN® SUSPENSION 2 OZ. BERRY FLAVOR 50580-601-02

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY FLAVOR 50580-601-04

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. TROPICAL PUNCH FLAVOR 50580-215-04

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. GRAPE FLAVOR 50580-603-04

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BUBBLEGUM FLAVOR 50580-604-04

CHILDREN’S MOTRIN® SUSPENSION 1 OZ. GRAPE SAMPLE 50580-603-01

CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BUBBLEGUM SAMPLE 50580-604-01

CHILDREN’S MOTRIN® SUSPENSION 1 OZ. BERRY SAMPLE 50580-601-01

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. BERRY HOSPITAL 50580-601-50

CHILDREN’S MOTRIN® SUSPENSION 4 OZ. COLD BERRY FLAVOR 50580-902-04

CHILDREN’S ZYRTEC® LIQUIDS IN BOTTLES

CHILDREN’S ZYRTEC® 4 OZ. BUBBLEGUM SYRUP 50580-721-04

CHILDREN’S ZYRTEC® DYE FREE 4 OZ. GRAPE SYRUP 50580-730-04

CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. GRAPE 50580-730-15

CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 0.5 OZ. BUBBLEGUM 50580-721-15

CHILDREN’S ZYRTEC® SUGAR-FREE DYE-FREE 2 X 4 OZ. BUBBLEGUM LIQUID 50580-721-08

CHILDREN'S BENADRYL® ALLERGY LIQUIDS IN BOTTLES

CHILDREN'S BENADRYL® ALLERGY 4 OZ. BUBBLEGUM FLAVORED LIQUID 50580-535-04

* CONCENTRATED TYLENOL® INFANTS’ DROPS 0.5 OZ. GRAPE FLAVOR is also included in JOHNSON'S ® Baby Relief Kit.

*CONCENTRATED MOTRIN® INFANTS’ DROPS 0.5 OZ. BERRY FLAVOR is also included in JOHNSON'S ® Baby Relief Kit

fda

Child Abuse Prevention

April is National Child Abuse Prevention Month

Approximately 772,000 children are confirmed by Child Protective Services each year as being abused or neglected. These confirmed cases, however, represent only a fraction of the true magnitude of the problem.

Child maltreatment is a significant public health problem in the United States. In 2007, approximately 772,000 children were confirmed by Child Protective Services as being abused or neglected. These confirmed cases, however, represent only a fraction of the true magnitude of the problem. Most cases are not reported and child maltreatment remains a largely hidden problem.

There is overwhelming scientific evidence that child maltreatment can lead to a broad range of physical and emotional health problems. Short-term physical injuries include cuts, bruises, burns, and broken bones. Abuse can also lead to permanent disabilities including visual, motor, and cognitive impairments. Prolonged maltreatment causes extreme or "toxic" stress that can disrupt early brain development and impair the functioning of the nervous and immune systems, leaving children vulnerable to chronic diseases later in life. For example, maltreatment has been associated with heart, lung, and liver disease in adulthood.

Not all injuries that result from child maltreatment are visible. Abuse and neglect can have a lasting emotional impact as well. Victims may suffer from anxiety or depression. They may be wary, distrustful of others, and have difficulty establishing relationships. Some even think about or attempt suicide.

The Centers for Disease Control and Prevention (CDC) works to stop maltreatment, including abuse and neglect, before it initially occurs. In doing this, CDC promotes the development of safe, stable, and nurturing relationships between children and their parents or caregivers. Children's experiences are defined through their relationships with parents, teachers, and other caregivers. Healthy relationships act as a buffer against adverse childhood experiences. They are necessary to ensure the long-term physical and emotional well-being of children.

CDC

Childhood Asthma

Childhood Asthma Treatment: Not One-Size-Fits-All

Study helps guide treatment choices

A new study has found the addition of long-acting beta-agonist therapy to be the most effective of three step-up, or supplemental, treatments for children whose asthma is not well controlled on low doses of inhaled corticosteroids alone.

The study was designed to provide needed evidence for selecting step-up care for such children and was supported by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. Researchers also identified patient characteristics, such as race, that can help predict which step-up therapy is more likely to be the most effective for a child with persistent asthma.

The study found that almost all of its participants had a different response to the three different treatments. Although adding the long acting beta-agonist step-up was one and one-half times more likely to be the best treatment for most of the study group, many children responded best to other two treatments instead.

The results were presented March 2 at the American Academy of Asthma, Allergy and Immunology 2010 Annual Meeting in New Orleans and are published online in the New England Journal of Medicine.

"These results fill an important gap in our asthma guidelines," said NHLBI Acting Director Susan B. Shurin, M.D., a board-certified pediatrician. "At the time the guidelines were written, there were very few comparison studies conducted in children whose asthma was poorly controlled with low-dose inhaled corticosteroids. Now that we have these study data, we can more confidently make recommendations for these children."

The NHLBI's Guidelines for the Diagnosis and Management of Asthma (EPR-3) recommend three treatment options for children with mild to moderate persistent asthma – for example, those experiencing symptoms at least two days per week – whose asthma is not well controlled on low doses of inhaled corticosteroids. These treatments, which were featured in the study, are adding a long acting beta agonist to the low-dose inhaled corticosteroids; adding a leukotriene receptor antagonist to the low-dose inhaled corticosteroids; and doubling the dose of inhaled corticosteroids. These recommendations were based on data collected from adults.

The study, called Best Add on Therapy Giving Effective Responses (BADGER), compared how effectively the three different step-up treatments improved asthma control in 182 children ages 6 to 18 years. All participants had mild to moderate persistent asthma that was not controlled on low-dose inhaled corticosteroids. Participants received each of the three treatments, with each treatment period lasting 16 weeks.

Responses were measured based on three factors: number of asthma episodes requiring oral corticosteroids, number of days of well controlled asthma, and lung function as measured by the amount of air exhaled in one second.

Overall, adding a long-acting beta-agonist to inhaled corticosteroids was significantly more likely (1.5 times) to be the best step-up therapy as compared to adding a leukotriene receptor antagonist to inhaled corticosteroids or to doubling inhaled corticosteroids.

Nearly all the children responded differently to the three treatments, with 45 percent of children responding best to adding a long-acting beta-agonist, 28 percent responding best to adding leukotriene receptor antagonist, and 27 percent responding best to doubling the dose of inhaled corticosteroids.

The study also identified several patient characteristics that increased the likelihood of identifying which step-up treatment would be more effective for an individual child. For example, African-American study participants were equally likely to respond best to long-acting beta-agonist step-up or inhaled corticosteroids step-up, and least likely to respond best to leukotriene receptor antagonist step-up. For white participants, the addition of a long-acting beta-agonist was clearly the most likely step-up therapy to give the best response, with inhaled corticosteroids step-up the least favorable therapy.

In addition, a long-acting beta-agonist was more likely to be the most effective step-up therapy among children who started the study with high scores on the Asthma Control Test, a five-item health survey used to measure asthma control, and among those who did not have eczema, an allergic skin condition.

"This study underscores the fact that individuals respond differently to different therapies " childhood asthma treatment is not one-size-fits-all," said Robert F. Lemanske, Jr., M.D., of the University of Wisconsin Hospital-Madison, one of the principal investigators of the study and lead author of the paper. "It is important to monitor the child’s response closely and, if necessary, adjust therapy with one of the other options within this step of care before moving to a higher step of care."

The benefit of adding a different class of medication may be because of a possible ceiling effect for low-dose inhaled corticosteroids in some children, Dr. Lemanske said.

The observed overall best performance of long-acting beta-agonist step-up should be weighed against the increased risk of severe worsening of asthma symptoms leading to hospitalization and, in rare cases, death, as noted in the U.S. Food and Drug Administration approved labeling for long-acting beta agonists. Although there were no safety differences among the treatments during this study, the researchers assert the BADGER trial was not designed or powered to evaluate long-term safety of long-acting beta-agonists in children.

"This is the kind of study that will advance strategies for personalized medicine and improve treatment for children who have asthma," said James Kiley, Ph.D, director of the NHLBI Division of Lung Diseases.

According to the Centers for Disease Control and Prevention, almost 7 million children in the United States have asthma, a leading cause of hospitalizations and school absenteeism. Common asthma symptoms include wheezing, shortness of breath, chest tightness, and coughing. While there is no cure for asthma, most children who receive effective treatment are able to control symptoms.

The study was conducted by researchers with the NHLBI's Childhood Asthma Research and Education Network (CARE) centers. The CARE Network was established in 1999 to evaluate treatments for children with asthma; study sites are Penn State College of Medicine, Hershey, Pa.; National Jewish Health, Denver; University of Wisconsin – Madison; University of California, San Diego/Kaiser Permanente Medical Center; Washington University School of Medicine, St. Louis, Mo.; and University of Arizona College of Medicine, Tucson.

CARE centers also received support for this study from the National Center for Research Resources and the National Institute of Allergy and Infectious Disease, both part of NIH. Medications were provided by GlaxoSmithKline and Merck, Inc.

NIH

What is X-linked adrenal hypoplasia congenita?

X-linked adrenal hypoplasia congenita is a disorder that mainly affects males. It involves many hormone-producing (endocrine) tissues in the body, particularly a pair of small glands on top of each kidney called the adrenal glands. These glands produce a variety of hormones that regulate many essential functions in the body.

One of the main signs of this disorder is adrenal insufficiency, which occurs when the adrenal glands do not produce enough hormones. Adrenal insufficiency typically begins in infancy or childhood and can cause vomiting, difficulty with feeding, dehydration, extremely low blood sugar (hypoglycemia), and shock. If untreated, these complications are often life-threatening.

Affected males may also have a shortage of male sex hormones, which leads to underdeveloped reproductive tissues, undescended testicles (cryptorchidism), delayed puberty, and an inability to father children (infertility). Together, these characteristics are known as hypogonadotropic hypogonadism.

The onset and severity of these signs and symptoms can vary, even among affected members of the same family.

How common is X-linked adrenal hypoplasia congenita?

X-linked adrenal hypoplasia congenita is estimated to affect 1 in 12,500 newborns.

What genes are related to X-linked adrenal hypoplasia congenita?

Mutations in the NR0B1 gene cause X-linked adrenal hypoplasia congenita. The NR0B1 gene provides instructions to make a protein called DAX1. This protein plays an important role in the development and function of several hormone-producing (endocrine) tissues including the adrenal glands, two hormone-secreting glands in the brain (the hypothalamus and pituitary), and the gonads (ovaries in females and testes in males). The hormones produced by these glands control many important body functions.

Some NR0B1 mutations result in the production of an inactive version of the DAX1 protein, while other mutations delete the entire gene. The resulting shortage of DAX1 disrupts the normal development and function of hormone-producing tissues in the body. The signs and symptoms of adrenal insufficiency and hypogonadotropic hypogonadism occur when endocrine glands do not produce the right amounts of certain hormones.

How do people inherit X-linked adrenal hypoplasia congenita?

This condition is inherited in an X-linked recessive pattern. A condition is considered X-linked if the mutated gene that causes the disorder is located on the X chromosome, one of the two sex chromosomes. In males (who have only one X chromosome), one altered copy of the gene in each cell is sufficient to cause the condition. In females (who have two X chromosomes), a mutation must be present in both copies of the gene to cause the disorder. Males are affected by X-linked recessive disorders much more frequently than females. A striking characteristic of X-linked inheritance is that fathers cannot pass X-linked traits to their sons.

In X-linked recessive inheritance, a female with one mutated copy of the gene in each cell is called a carrier. She can pass on the altered gene, but usually does not experience signs and symptoms of the disorder. In rare cases, however, females who carry a NR0B1 mutation may experience adrenal insufficiency or signs of hypogonadotropic hypogonadism such as underdeveloped reproductive tissues, delayed puberty, and an absence of menstruation.

nih

Infant Health

Infant Health What is infancy? Infancy is generally the period from birth until age two years. It is a time of a lot of growth and change for children and families. This health topic covers some of the many issues related to infant care, including: [jump to sections on feeding, sleeping, safety and childcare below] This information is provided with full-term infants specifically in mind. It is not meant to provide all the information you need to care for your infant. Preterm infants (those born before the mother has been pregnant about 38 weeks) often have special needs. See the section below for more details on preterm infants. [jump to preterm section below] What are the best strategies for feeding my baby? Breastfeeding, also called nursing, is often the ideal source of nutrition for newborns and can be an easy, healthy, and inexpensive way for a mother to feed her child. Why is breastfeeding recommended? Breast milk contains a wide range of nutrients important for baby’s growth and health. In addition, recent NICHD-supported research also suggests that some of the specific fatty acids contained in breast milk play important roles in helping brain development. For example, two specific fatty acids, known as DHA and AA, may help increase infants’ cognitive skills. Breastfeeding is beneficial to the mother, too:        Nursing helps a woman’s body secrete hormones, causing her uterus to contract and heal. These hormones also postpone the restarting of menstruation.        Breastfeeding reduces the chance of postpartum depression, enhances mother-infant bonding, and can create a sense of accomplishment and satisfaction.        Some authorities believe that breastfeeding women have lower risks of developing breast and uterine cancers. How long should a mother breastfeed? According to the American Academy of Pediatrics (AAP) Policy Statement on Breastfeeding, women who don’t have health problems should feed their infants only breast milk for at least the first six months of life. After this time, the AAP suggests that women try to continue to breastfeed for the first 12 months of life because of the benefits to both the mother and baby. The AAP recommends that infants who are weaned (meaning they are no longer breastfed) before 12 months of age should drink iron-fortified infant formula and not cow’s milk. Many types of infant formulas available in the United States are fortified with DHA and AA, and all formula available for preterm infants is fortified with these fatty acids. The AAP also suggests introducing solid foods at six months of age. The Academy recommends introducing single-ingredient foods one at a time for a several-day trial before adding a new food. During the first six months, water, juice, and other foods are generally unnecessary for breastfed infants. Infants should not have anything with fluoride, such as adult toothpaste, during their first six months, whether they are breast- or formula-fed. What is jaundice? Jaundice (jawn-DISS) is an illness that can cause a baby's skin, eyes, and mouth to turn a yellowish color. The yellow color is caused by a buildup of bilirubin, a substance that is produced in body during the normal process of breaking down old red blood cells and forming new ones. What causes jaundice? Normally the liver removes bilirubin from the body. But for many babies, in the first few days after birth the liver is not yet working at its full power. As a result, bilirubin level in the blood gets too high, causing the baby’s color to become slightly yellow. This is called jaundice. If your baby has jaundice, it usually does not mean that your baby has liver problems or a “bad liver.” In most cases, it just means that the baby’s liver is slower in removing bilirubin from the blood during the first few days after birth. How is jaundice treated? Although jaundice is common and is often not serious, all babies with jaundice need to be seen by a health care provider. Many babies need no treatment for jaundice. Their livers start to catch up quickly, usually within a few days after birth, and begin to remove bilirubin normally. For some babies, however, doctors prescribe photo-therapy—treatment using a special lamp—to help break down the bilirubin in their bodies. In some cases, high levels of bilirubin could cause brain injury. If your baby has jaundice, ask your health care provider how long his or her jaundice will last after leaving the hospital, and schedule a followup appointment as directed. If your baby’s jaundice lasts longer than expected, or an infant who did not have jaundice before starts to turn yellowish after going home, contact your health care provider right away. How can I help my child with sleep? Helping a child learn to fall asleep and stay asleep is one of the more challenging parts of infant care. Newborns tend to sleep or drowse for 16 to 20 hours a day. Their “internal clocks” are not yet set, so they sleep a lot both during the day and night. Newborns also have small stomachs, so they need to be awake for regular feedings. After a few months, babies usually begin to sleep in longer stretches at night and are awake for longer periods during the day. Practicing bedtime routines and putting your baby into the crib before he or she falls asleep can help build better sleep patterns. What is Sudden Infant Death Syndrome (SIDS)? SIDS is the sudden, unexplained death of an infant younger than one year old. It is the leading cause of death in children between one month and one year of age. Health care providers don’t know exactly what causes SIDS, but they do know certain things can help reduce the risk of SIDS. How can parents reduce the risk of SIDS? The best way to reduce the risk of SIDS is to always place babies on their backs to sleep for naps and at night. Babies who sleep on their backs are less likely to die of SIDS than babies who sleep on their stomachs or sides. Placing your baby on his or her back to sleep, for naps and at night, is the number one way to reduce the risk of SIDS. What are some ways to keep my baby safe? Keeping your baby safe is one of the most important jobs for parents. The U.S. Consumer Product Safety Commission publishes a booklet called The Safe Nursery (PDF – 603 KB) that provides information on a variety of potential hazards and ways to help keep your infant safe. What about safety for my infant in the car? In addition to safety at home, car seat safety is an important part of taking care of your child. The AAP publishes Car Safety Seats: A Guide for Families, which discusses what type of car seats are best at what ages and other important aspects of car seat safety. Each car seat is different so it is important to carefully review and follow the manufacturer’s instructions. What is hyperthermia and how can I prevent it in my child? The term hyperthermia (pronounced high-purr-THER-mee-yah) refers to heat-related illnesses—or those associated with exposure to high temperature in the environment, causing high body temperature. When the body is exposed to high temperatures, like on a hot day, the body normally cools itself using different mechanisms, such as heavy sweating and losing heat through the skin. But in certain situations, such as when inside a parked car when it is warm or humid, or in a desert climate where it is can be very hot and dry, sweating and other mechanisms may not be enough to cool high body heat. As a result, the body’s temperature rises quickly and may damage the brain and other organs in the body. Normal body temperature is 98.6 degrees Fahrenheit—Hyperthermia occurs when the body heats up to 104 degrees Fahrenheit. Body temperature of 107 degrees is usually fatal. Heat illnesses typically progress from “heat stress”—Physical and emotional stress at being in a hot environment; to “heat exhaustion”—characterized by dehydration, extreme thirst, and weakness/dizziness; to “heat stroke”—which may cause delirium, convulsions, coma, and death. In the last decade, deaths from hyperthermia have increased, especially among children and pets, mainly as a result of them being left alone in a car for even short periods of time. A child’s body is less effective at cooling itself than an adult body is, and adults can alter their environment by taking off clothes. Even when the outside temperature is at “room temperature” (about 72 degrees Fahrenheit), the temperature inside a car can increase to more than 100 degrees Fahrenheit in just 30 minutes. So, even when the weather is comfortable outside, children are at high risk for heat stroke and death from being left alone in a car. Parents and caregivers should never leave a child alone in a car, not even with the windows down, and not even for a minute. Parents and caregivers should also develop plans for leaving their car to ensure that everyone exits the car safely and no one is left in the car accidentally. If you see a child left alone in a parked car, you should call 911 to request emergency help—It could mean the difference between life and death for that child. What about child care for infants? For many parents and families, child care comes from someone other than the child’s mother. To understand how this type of care influences child development, the NICHD started the Study of Early Child Care and Youth Development (SECCYD) in 1991. The major goal of the study was to examine how differences in child care experiences relate to children’s social, emotional, intellectual, and language development, and to their physical growth and health. The study examined how quality, quantity, and type of child care setting affect children’s development. Specific findings from the Study include the following:        Higher quality care was associated with better child outcomes.        The number of hours in care mattered in terms of child outcomes to some degree.        The child care type or setting (child care home, child care center, etc.) had different effects on children at different ages.        Parent and family characteristics were more strongly linked to child development and child outcomes than any aspect of child care. The Study also developed a Positive Caregiving Checklist (PDF – 1.16 MB) that parents can use to examine the quality of care their child is receiving. Do preterm infants have special care needs? Preterm infants, also known as preemies, are babies born before the mother has completed 37 weeks of pregnancy (or on or before 259 days from the first day of the last menstrual period). Preterm infants often have special needs, even after they leave the hospital. Infants born only a few weeks preterm (between 34 and 37 weeks, or “late preterm”) often have special needs during the first two years of age. Preterm infants may need to spend time in a Neonatal Intensive Care Unit (NICU) at the hospital until they are big and strong enough to go home. Preterm babies may also need special care even after leaving the NICU. You should talk to your health care provider about your infant’s specific care needs. NICHD

H1N1 Flu and Asthma

Nose Disorders

Also called: Nasal disorders

Whether it's large or small, button-like or beak-like, your nose is important to your health. It filters the air you breathe, removing dust, germs and irritants. It warms and moistens the air to keep your lungs and tubes that lead to them from drying out. Your nose also contains the nerve cells that help your sense of smell. When there is a problem with your nose, your whole body can suffer. For example, the stuffy nose of the common cold can make it hard for you to breathe, sleep or get comfortable.

Many problems besides the common cold can affect the nose. They include

• Deviated septum – a shifting of the wall that divides the nasal cavity into halves
• Nasal polyps – soft growths that develop on the lining of your nose or sinuses
• Nosebleeds
• Rhinitis – inflammation of the nose and sinuses sometimes caused by allergies. The main symptom is a runny nose

Medlineplus

Folic Acid can help prevent major birth defects

Folic acid is very important because it can help prevent major birth defects of the baby’s brain and spine (anencephaly and spina bifida) by 50% to 70%.

How much folic acid a woman needs

400 micrograms (mcg) every day.

When to start taking folic acid

For folic acid to help prevent major birth defects, a woman needs to start taking it at least one month before she becomes pregnant and while she is pregnant.

However, every woman needs folic acid every day, whether she’s planning to get pregnant or not, for the healthy new cells the body makes daily. Think about the skin, hair, and nails. These – and other parts of the body – make new cells each day.

How a woman can get enough folic acid

There are two easy ways to be sure to get enough folic acid each day:

1.Take a vitamin that has folic acid in it every day.

Most multivitamins sold in the United States have the amount of folic acid women need each day. Women can also choose to take a small pill (supplement) that has only folic acid in it each day.

Check the label on your vitamins to be sure it contains 100% of the daily value (DV) of folic acid, which is 400 micrograms (mcg).

Eat a bowl of breakfast cereal that has 100% of the daily value of folic acid every day.

Not every cereal has this amount. Check the label on the side of the box, and look for one that has “100%” next to folic acid.

cdc

Glycogen storage disease type II (GSD II), or Pompe disease

Glycogen storage disease type II (GSD II), or Pompe disease, is classified by age of onset, organ involvement, severity, and rate of progression. Classic infantile-onset Pompe disease may be apparent in utero but more often presents in the first month of life with hypotonia, generalized muscle weakness, cardiomegaly and hypertrophic cardiomyopathy, feeding difficulties, failure to thrive, respiratory distress, and hearing loss. Without treatment by enzyme replacement therapy (ERT), classic infantile-onset Pompe disease commonly results in death in the first year of life from progressive left ventricular outflow obstruction. The non-classic variant of infantile-onset Pompe disease usually presents within the first year of life with motor delays and/or slowly progressive muscle weakness, typically resulting in death from ventilatory failure in early childhood. Cardiomegaly can be seen, but heart disease is not a major source of morbidity. Late-onset (i.e., childhood, juvenile, and adult-onset) Pompe disease is characterized by proximal muscle weakness and respiratory insufficiency without cardiac involvement.

CDC

It’s Not Too Late to Vaccinate!

This week is National Influenza Vaccination Week, and it’s a great time to get vaccinated against the H1N1 flu.

Flu is unpredictable, and this flu season is far from over. Flu season typically lasts until May, and we don’t know whether there will be additional waves of flu illness. H1N1 is still circulating, it’s still dangerous, and there are still lives to be saved. That’s why it’s so critical for everyone to get vaccinated.

While over 60 million people have received the H1N1 vaccine, over three-fifths of Americans have not yet gotten it. It’s easy to find a flu vaccination location near you.

CDC

Childhood Extracranial Germ Cell Tumors

Childhood extracranial germ cell tumors form from developing sperm or egg cells that travel to parts of the body other than the brain.

As a fetus develops, certain cells form sperm in the testicles or eggs in the ovaries. Sometimes these cells travel to other parts of the body and grow into germ cell tumors. This summary is about germ cell tumors that form in parts of the body that are extracranial (outside the brain). Extracranial germ cell tumors are most common in teenagers 15 to 19 years old.

Childhood extracranial germ cell tumors may be benign or malignant.

Extracranial germ cell tumors may be benign (noncancer) or malignant (cancer).

There are three types of extracranial germ cell tumors.

Extracranial germ cell tumors are grouped into mature teratomas, immature teratomas, or malignant germ cell tumors:

Mature Teratomas

Mature teratomas are the most common type of extracranial germ cell tumor. The cells of mature teratomas look very much like normal cells. Mature teratomas are benign and not likely to become cancer.

Immature Teratomas

Immature teratomas have cells that look very different from normal cells. They are more likely to become cancer.

Malignant Germ Cell Tumors

Malignant germ cell tumors are cancer. There are three types of malignant germ cell tumors:

• Yolk sac tumors: Tumors that make a hormone called alpha-fetoprotein (AFP).
• Germinomas: Tumors that make a hormone called beta-human chorionic gonadotropin (β-hCG).
• Choriocarcinomas: Tumors that make a hormone called beta-human chorionic gonadotropin (β-hCG).

Childhood extracranial germ cell tumors are grouped as gonadal or extragonadal.

Malignant extracranial germ cell tumors are grouped into gonadal and extragonadal.

Gonadal Germ Cell Tumors

Gonadal germ cell tumors form in the testicles or ovaries.

Testicular Germ Cell Tumors

Testicular germ cell tumors usually occur before the age of 4 years or in teenagers and young adults.

Testicular germ cell tumors in teenagers and young adults are different from those that form in early childhood. They are more like testicular cancer in adults. Testicular germ cell tumors are divided into two main types, nonseminoma and seminoma.

• Nonseminoma: These tumors are usually large and cause symptoms. They tend to grow and spread more quickly than seminomas.
• Seminoma: These tumors make a hormone called beta-human chorionic gonadotropin (β-hCG). They are more sensitive to radiation therapy than nonseminomas.

Boys older than 14 years with testicular germ cell tumors are treated in pediatric cancer centers, but the treatment is similar to that used in adults.

Ovarian Germ Cell Tumors

Ovarian germ cell tumors form in egg-making cells in an ovary. These tumors are more common in teenage girls and young women. Most ovarian germ cell tumors are benign teratomas.

Extragonadal Extracranial Germ Cell Tumors

Extragonadal germ cell tumors form in areas other than the testicles or ovaries.

Most germ cell tumors that are not in the testicles, ovaries, or brain, form along the midline of the body. This includes the following:

• Sacrum (the large, triangle-shaped bone in the lower spine that forms part of the pelvis).
• Coccyx (the small bone at the bottom of the spine, also called the tailbone).
• Mediastinum (the area between the lungs).
• Back of the abdomen.
• Neck.

In younger children, extragonadal extracranial germ cell tumors usually occur at birth or in early childhood. Most of these tumors are teratomas in the sacrum or coccyx.

In older children, teenagers, and young adults, extragonadal extracranial germ cell tumors are often in the mediastinum.

The cause of most childhood extracranial germ cell tumors is unknown.

Having certain inherited disorders can increase the risk of developing an extracranial germ cell tumor.

Anything that increases your risk of getting a disease is called a risk factor. Having a risk factor does not mean that you will get cancer; not having risk factors doesn’t mean that you will not get cancer. People who think they may be at risk should discuss this with their doctor. Possible risk factors for extracranial germ cell tumors include the following:

• Having certain genetic syndromes may increase the risk of developing childhood germ cell tumors:

• • Klinefelter syndrome may increase the risk of developing germ cell tumors in the mediastinum.
  • Swyer syndrome may increase the risk of developing germ cell tumors in the testes or ovaries.

• Having an undescended testicle may increase the risk of developing a testicular germ cell tumor.

Signs of childhood extracranial germ cell tumors depend on the type of tumor and where it is in the body.

Different tumors may cause the following signs and symptoms. Other conditions may cause these same symptoms. A doctor should be consulted if any of these problems occur.

• Most tumors of the sacrum and coccyx can be seen as a lump.
• A testicular tumor may cause a painless lump in the testicles.
• An ovarian germ cell tumor may cause:

• • Pain or a lump in the abdomen.
  • Fever.
  • Constipation.
  • No menstruation.
  • Unusual vaginal bleeding.

Imaging studies and blood tests are used to detect (find) and diagnose childhood extracranial germ cell tumors.

The following tests and procedures may be used:

• Physical exam and history: An exam of the body to check general signs of health, including checking for signs of disease, such as lumps or anything else that seems unusual. The testicles may be checked for lumps, swelling, or pain. A history of the patient's health habits and past illnesses and treatments will also be taken.
• Serum tumor marker test: A procedure in which a sample of blood is checked to measure the amounts of certain substances released into the blood by organs, tissues, or tumor cells in the body. Certain substances are linked to specific types of cancer when found in increased levels in the blood. These are called tumor markers. Most malignant germ cell tumors release tumor markers. The following tumor markers are used to detect extracranial germ cell tumors:

• • Alpha-fetoprotein (AFP).
  • Beta-human chorionic gonadotropin (β-hCG).

• For testicular germ cell tumors, blood levels of the tumor markers help show if the tumor is a seminoma or nonseminoma.
• Blood chemistry studies: A procedure in which a blood sample is checked to measure the amounts of certain substances released into the blood by organs and tissues in the body. An unusual (higher or lower than normal) amount of a substance can be a sign of disease in the organ or tissue that makes it.
• Cytogenetic analysis: A laboratory test in which cells in a sample of tissue are viewed under a microscope to look for certain changes in the chromosomes.
• Immunohistochemistry study: A laboratory test in which a substance such as an antibody, dye, or radioisotope is added to a sample of cancer tissue to test for certain antigens. This type of study is used to tell the difference between different types of cancer.
• Chest x-ray: An x-ray of the organs and bones inside the chest. An x-ray is a type of energy beam that can go through the body and onto film, making a picture of areas inside the body.
• CT scan (CAT scan): A procedure that makes a series of detailed pictures of areas inside the body, taken from different angles. The pictures are made by a computer linked to an x-ray machine. A dye may be injected into a vein or swallowed to help the organs or tissues show up more clearly. This procedure is also called computed tomography, computerized tomography, or computerized axial tomography.
• Ultrasound exam: A procedure in which high-energy sound waves (ultrasound) are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissues called a sonogram. The picture can be printed to be looked at later.
• Biopsy: The removal of cells or tissues so they can be viewed under a microscope by a pathologist to check for signs of cancer. In some cases, the tumor is removed during surgery and then a biopsy is done.

Certain factors affect prognosis (chance of recovery) and treatment options.

The prognosis (chance of recovery) and treatment options depend on the following:

• The type of germ cell tumor.
• Where the tumor first began to grow.
• The stage of the cancer (whether it has spread to nearby areas or to other places in the body).
• Whether the tumor can be completely removed by surgery.
• The patient's age and general health.
• Whether the cancer has just been diagnosed or has recurred (come back).

The prognosis for childhood extracranial germ cell tumors, especially ovarian germ cell tumors, is good.

National Cancer Institute

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