Taro Receives FDA Approval For Cetirizine Hydrochloride Oral Solution, 1 Mg/mL (Sugar Free Bubble Gum Flavor)
Taro Pharmaceutical has received approval from the FDA for its Abbreviated New Drug Application for Cetirizine Hydrochloride Oral Solution, 1 mg/mL (Sugar Free Bubble Gum) ("Cetirizine Oral Solution"). Taro's Cetirizine Oral Solution is an over-the-counter antihistamine used for the relief of sneezing, runny nose, itchy, watery eyes and itchy throat or nose due to indoor and outdoor allergies and for the relief of itching due to hives and is bioequivalent to Children's Zyrtec® Syrup, 5mg/5mL of McNeil Consumer Healthcare.

No More Infant Dose of OTC Acetaminophen

Over-the-counter drug makers have announced that they will no longer produce acetaminophen in concentrated infant drops; liquid acetaminophen products for children under 12 will be sold only in a 160 mg/5 mL concentration. The Consumer Healthcare Products Association (CHPA), the chief trade group for OTC drug manufacturers, indicated the move is intended to reduce dosing errors.Currently, liquid acetaminophen formulations for children ages 2 to 11 come in the 160 mg/5 mL strength, but more concentrated products - 80 mg/0.8 mL and 80 mg/1.0 mL - are sold for infants, with droppers for administration. "CHPA member companies are voluntarily making this conversion to one concentration to help make it easier for parents and caregivers to appropriately use single-ingredient liquid acetaminophen," said CHPA president and CEO Scott Melville in a statement. Manufacturers will also be adopting syringes with dose restrictors for products intended for infants, the CHPA indicated, but cups will continue to be provided for older children. The shift will begin in the middle of the year, the group said, but it warned that there will be a "transition period" during which multiple concentrations of the infant products may be on store shelves simultaneously. "During the transition, the makers of these medicines also will work with retailers to ensure that, as the new medicines are introduced, the more concentrated infant drops will be removed from store shelves," the CHPA statement indicated. "Consumers should always read and follow the label and pay particular attention to the concentration, especially when a healthcare provider gives dosing instructions," it added.

FDA Approves NEXIUM(R) I.V. (Esomeprazole Sodium) For The Treatment Of GERD With Erosive Esophagitis In Pediatric And Adolescent Patients

The FDA has approved the use of NEXIUM® I.V. (esomeprazole sodium) for Injection for children ages greater than 1 month old for the short-term treatment of gastroesophageal reflux disease (GERD) with erosive esophagitis when oral therapy is not possible or appropriate.1 NEXIUM I.V. is the first proton pump inhibitor approved for children under one year old. "This approval of NEXIUM I.V. for the treatment of children 1 month to 17 years old who are suffering from GERD with erosive esophagitis, gives physicians an important option in the treatment of infants and children," said Marta Illueca, MD, FAAP, executive director of gastrointestinal disorders for AstraZeneca. "This approval represents an important contribution to an unmet medical need for infants in particular. While some reflux and regurgitation are normal in infants and may not require medical treatment, persistent GERD symptoms can be very uncomfortable and cause damage to the esophagus, just as they can in older patients. Close medical supervision is key in the appropriate diagnosis and choice of treatment for these infants," continued Illueca. For first-line treatment of pediatric GERD, families are encouraged to try lifestyle modifications, such as smaller, more frequent feedings or dietary changes. If these methods fail, physicians until now have very few approved pharmacological options. NEXIUM I.V. is the first proton pump inhibitor approved for use in infants younger than 1 year old. NEXIUM I.V. for Injection is an alternative to oral therapy when oral therapy is not possible or appropriate and is administered in the hospital by a health care professional. Treatment with NEXIUM I.V. for more than 10 days has not been studied.

FDA Approves The First Vaccine To Prevent Meningococcal Disease In Infants And Toddlers
The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Even with appropriate antibiotics and intensive care, between 10 percent and 15 percent of people who develop meningococcal disease die from the infection. Another 10 percent to 20 percent suffer complications such as brain damage or loss of limb or hearing.

Although the rates of meningococcal disease are low in the United States, infants and toddlers are more susceptible to getting this serious illness. Meningococcal disease is particularly dangerous because it progresses rapidly and can cause death within hours. Early symptoms are often difficult to distinguish from influenza and other common illnesses.

"The highest rate of meningococcal disease occurs in children under one year of age. With today's approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease," said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which over 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability. Occurrence of fever was comparable to other vaccines routinely recommended for young children.

Menactra is given as a two-dose series beginning at 9-months, three months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

Menactra was originally approved on Jan. 14, 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years. Menactra is manufactured by Sanofi Pasteur.

Are your children’s vaccinations up-to-date before traveling by air?
According to the Centers for Disease Control (CDC), in the past year alone there were more than 3,000 known airline passengers traveling while ill with a contagious disease.

 1. The aircraft cabin environment abets the spread of disease-causing microorganisms. Infected passengers cough up, sneeze out and exhale these organisms. Factors that favor this spread include close and prolonged contact with other passengers and, possibly, the vagaries of ventilation systems, dryness of the cabin air, and the presence of passengers originating in countries where such diseases are prevalent.

2. Likely, the number of ill passengers is far greater than the number reported. This further increases the risk of spreading disease. Some ill travelers conceal the fact that they are ill while others are in the incubation period – already contagious but not yet symptomatic and thus unaware that they are ill. The CDC recommends not traveling until 24 hours after fever subsides.  But ill persons are often reluctant to cancel scheduled trips.  One reason is that some airlines penalize for last-minute cancellations regardless of the reason are an additional disincentive.

 3. Airport personnel can refuse boarding when passengers appear ill. But, in fact, this is rarely done. (Most people denied boarding are under the influence of alcohol or drugs.)Airport personnel are poorly trained in recognizing infectious illnesses and say it is a “hassle to get involved.” They can telephone airline medical staff for advice but the staff is rarely on the premises.

 4. The CDC has guidelines for handling visibly ill passengers in flight. But the crew rarely takes action. They can ask passengers to wear surgical masks (carried on most aircraft), isolate the passengers (if room is available), contact consultants on the ground for guidance, have quarantine officers meet the aircraft on landing, and, for long flights, make unscheduled stops at a closer airport than the destination.

 5. Most diseases transmitted on aircraft are vaccine-preventable. The diseases most commonly found in the CDC survey were so-called childhood diseases: measles, mumps, chickenpox and pertussis (whooping cough). Other studies, done during flu epidemics, found passengers traveling with that disease. Optimally vaccinated children are already immune to these diseases. But an increasing number of parents refuse to vaccinate their children – though there is no known evidence that there are harmful effects.

6. Check with experts when traveling with infants. In infancy, immunity to vaccine-preventable diseases depends on many factors: the disease in question, immunity received from the mother during pregnancy, and vaccines administered to the infant. Generally routine vaccinations are started at about two months of age but infants are not fully protected until months later; many immunizations require multiple doses over many months to become protective. Sometimes, for travel, routine vaccination schedules may have to be altered, started earlier and repeated later, for example. Rarely, travel should be postponed. Decisions may depend on current disease activity at the destination.  Influenza vaccination is recommended for everyone who is six months of age and older. Influenza can be a serious disease for infants; hospitalization rates for infants from influenza approach those for the elderly.

7. Adults need vaccinations, too.  Many parents who opt not to vaccinate their children erroneously believe that the so-called “childhood” diseases affect only children. Unvaccinated children become unvaccinated adults. And infected adults spread diseases. Also, for some diseases, protection from vaccine administered in childhood wanes with age; in these cases booster doses are necessary.

8. Many childhood diseases are more serious in adulthood. Compared to children, adults who do become infected are more likely to have complications, the complications tend to be more severe, and the illness may last longer, prolonging the period that the adult remains contagious and is able to spread the disease. If women become infected during pregnancy, the fetus may be adversely affected.

9. Vaccinations are especially important for overseas travel. The lower the percentage of children vaccinated against a given disease in a country, the greater the risk of unvaccinated visitors contracting that disease. In many developing countries, many vaccines are largely unavailable. Moreover, travel to developing countries may require vaccines against diseases not seen back home (yellow fever and typhoid, for example).

10. Check vaccinations for cruises. Some conditions favoring the spread of disease-causing organisms in flight also occur on cruise ships: crowding (albeit less so than on aircraft), prolonged togetherness, common ventilation systems, and passengers from different parts of the world, for example. Also, check if vaccinations are necessary at scheduled ports-of call.

Bronchiolitis: Recent Evidence on Diagnosis and Management

Viral bronchiolitis is a leading cause of acute illness and hospitalization of young children. Research into the variation in treatment and outcomes for bronchiolitis across different settings has led to evidence–based clinical practice guidelines. Ongoing investigation continues to expand this body of evidence. Authors of recent surveillance studies have defined the presence of coinfections with multiple viruses in some cases of bronchiolitis. Underlying comorbidities and young age remain the most important predictors for severe bronchiolitis. Pulse oximetry plays an important role in driving use of health care resources. Evidence–based reviews have suggested a limited role for diagnostic laboratory or radiographic tests in typical cases of bronchiolitis. Several large, recent trials have revealed a lack of efficacy for routine use of either bronchodilators or corticosteroids for treatment of bronchiolitis. Preliminary evidence suggests a potential future role for a combination of these therapies and other novel treatments such as nebulized hypertonic saline.



Otitis Media Guidelines

Background: The American Academy of Pediatrics 2004 guidelines on diagnosis and management of acute otitis media (OM) recommends use of high-dose amoxicillin for the treatment of acute uncomplicated OM. With rising childhood obesity, recommended amoxicillin dose of 80 to 90 mg/kg per day often exceed standard adult dose of 1500 mg/d.  



Objective: To study prescribing patterns of primary care physicians for amoxicillin in the treatment of OM. To assess opinions of American Academy of Pediatrics subcommittee members who participated in guideline formulation.  



Methods: This study had 2 parts. Part 1: Retrospective review of medical records of children visiting the hospital between April and June 2008 and with a diagnosis of OM and were prescribed amoxicillin. Part 2: Web-based survey of 14 members of the OM guidelines subcommittee.  



Results: Part 1: Three hundred fifty-nine children were eligible, with a mean (SD) age of 3.2 (4.0) years and 185 (51.5%) of whom were males. Children weighing 20 kg or less received higher mean daily dose of amoxicillin (74.2 vs 40.4 mg/kg per day, P < 0.00). Part 2: Nine (64.3%) subcommittee members responded to the survey. Most (77.8%) affirmed that the impact of obesity on high-dose amoxicillin recommendation was not discussed during guideline formulation. If a patient's estimated amoxicillin dose exceeded the standard adult dose (1500 mg/d), 66.7% members would prescribe the standard adult dose whereas 33.3% would prescribe the recommended dose of 80 to 90 mg/kg per day.  



Conclusions: Primary care physicians prescribe a significantly lower-than-recommended amoxicillin dose in older children and those in the higher weight category. The opinion among subcommittee members regarding maximum dose specification of amoxicillin is varied.



Acute Bacterial Meningitis in Infants and Children

Bacterial meningitis continues to be an important cause of mortality and morbidity in neonates and children throughout the world. The introduction of the protein conjugate vaccines against Haemophilus influenzae type b, Streptococcus pneumoniae, and Neisseria meningitidis has changed the epidemiology of bacterial meningitis. Suspected bacterial meningitis is a medical emergency and needs empirical antimicrobial treatment without delay, but recognition of pathogens with increasing resistance to antimicrobial drugs is an important factor in the selection of empirical antimicrobial regimens. At present, strategies to prevent and treat bacterial meningitis are compromised by incomplete understanding of the pathogenesis. Further research on meningitis pathogenesis is thus needed.



Child Deaths Prompt FDA Warning on Cough Drug

After reviewing reports on 31 overdoses of the prescription cough medication benzonatate (Tessalon) - including the deaths of five toddlers - the FDA said it was beefing up the drug's label warnings and urging parents to keep it out of reach of children. The product is sold in colored gelcaps with a "candy-like" appearance, the agency indicated in a press release. "Benzonatate should be kept in a child-resistant container and stored out of reach of children," said Carol Holquist, RPh, director of the agency's Division of Medication Error Prevention and Analysis. "The FDA encourages healthcare professionals to talk with their patients and those caring for children about the risk of accidental ingestion or overdose." The product will remain on the market, but new label information will be added about risks of accidental ingestion resulting in overdose and death in children younger than 10. Benzonatate was approved in 1958 for treatment of coughs in patients 10 and older. It is available in 100- and 200-mg dosage forms. An FDA review of adverse event reports disclosed 31 cases of overdose in children and adults, ranging in age from 1 to 66. The overdoses involved as many as 30 gelcaps and as few as one. Most of these appeared deliberate. However, seven were ruled accidental, all of which occurred in children younger than 10. Five of these - all involving children younger than two - ended in death. Cardiac arrest, coma, and convulsions were common in the overdose cases. In six cases where the event report included information on time course of events, the FDA said, symptoms developed within an hour of ingestion, much faster in some cases. The agency recommended that healthcare professionals prescribe the minimum number of capsules needed to treat an episode. Providers should also advise parents to keep the capsules in childproof containers out of reach of children, the FDA said.



Dosing Instructions For OTC Medicines For Children Confusing, Hard To Follow

According to a study published online Nov. 30 in the Journal of the American Medical Association, many over-the-counter, liquid medications meant for children contain dosing instructions and measuring cups or droppers that rarely match each other and could confuse even the most careful parent or caretaker. As a result, this could easily lead to under- or over-dosing, with potentially dangerous consequences, researchers said. Twenty-six percent of products had no dispensers, such as a cup or medicine dropper, forcing parents to measure out doses themselves. But even products with dispensers had problems. For example, label instructions on 99% of these products conflicted with markings on the dispensing cup or dropper.         Last year, the Food and Drug Administration issued voluntary industry guidelines for the labels on nonprescription liquid children's medicines and measuring devices after numerous overdoses were attributed to confusing labels. The results of this new study may now be used to evaluate how well companies that make over-the-counter children's medicines improve their products, the researchers said.