Pediatrics

Kalydeco Approved to Treat Cystic Fibrosis in Children 12 to <24 Months

By August 17, 2018

The approval was supported by data from ARRIVAL (N=25), an ongoing Phase 3 open-label safety study in children with CF aged 12 to <24 months with 1 of 10 CFTR gene mutations (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D or R117H).

Does HPV Legislation Impact Teen Sexual Behaviors?

August 16, 2018

No substantive or significant associations between HPV legislation and adolescent sexual behaviors

Does Prenatal Tdap Vaccination Increase Autism Risk in Offspring?

By August 14, 2018

Currently, the Advisory Committee on Immunization Practices (ACIP) recommends pregnant women receive the Tdap vaccination to prevent pertussis infection.

Xolair Designated Breakthrough Therapy for Food Allergies

By August 13, 2018

The FDA designation was supported by data from 7 studies evaluating the safety and efficacy of Xolair against various food allergens (eg, peanut, milk, egg, others).

Nonmedical expenses of pediatric hospitalizations have disproportionate effects

August 13, 2018

Caregivers of hospitalized children had median nonmedical expenses and lost wages totaling $51.4 per day of hospitalization.

ADHD Medications Compared for Efficacy, Tolerability in Children and Adults

By August 13, 2018

The 7 treatments included in the study were amphetamines (including lisdexamfetamine), atomoxetine, bupropion, clonidine, guanfacine, methylphenidate, and modafinil.

Jornay PM Approved for the Treatment of ADHD

By August 09, 2018

Jornay PM utilizes the proprietary Delexis drug delivery platform which consists of 2 functional film coatings: the first layer delays the initial drug release for up to 10 hours and the second layer helps control the release rate of the active ingredient throughout the day.

FDA to Review Combo Nasal Spray for Seasonal Allergic Rhinitis

By August 08, 2018

The NDA included safety and efficacy data from 2 randomized, multicenter, double-blind, placebo-controlled trials in patients aged ≥12 years with seasonal allergic rhinitis (N=2352).

Orkambi Approved to Treat Younger Cystic Fibrosis Patients

By August 08, 2018

The approval was based on data from a 24-week, open-label, Phase 3 study in patients aged 2 to 5 years.

Kapspargo Sprinkle Available to Treat Hypertension, Angina, Heart Failure

By August 07, 2018

For patients unable to swallow an intact capsule, the pellets can be sprinkled over soft food (eg, applesauce, yogurt, pudding) or given via a nasogastric (NG) tube.

Topical Steroid Potencies

August 07, 2018

Topical steroid classification chart sorted by potency.

Rifampin Effective for Latent Tuberculosis in Children

August 07, 2018

Rifampin has advantage of being a shorter, single-drug regimen that is palatable for children

Alcohol Exposure Via Breastmilk May Affect Infant Development

August 02, 2018

The researchers found that in children who had been breastfed, there was a correlation for increased or riskier wave 1 maternal alcohol consumption with reductions in Matrix Reasoning scores at age 6 to 7.

Teen Boy Suffers Serious Burns After 'Hot Water Challenge'

July 31, 2018

Clark spent a week in the hospital. His doctors are hopeful that pigment will return in Clark's face within a few months.

Fatal Child Drownings in Open Water Areas Are Increasing

July 30, 2018

Young children or inexperienced swimmers should be within arm's reach of an adult, while older children should swim with a partner. Lastly, US Coast Guard-approved life jackets should be used in and around open water.

ACOG, Others Come Out Against Proposed Rule on Title-X

July 26, 2018

Organizations representing over 700,000 women and adolescent health care providers, including the ACOG, the AAP, and the American College of Physicians, are opposing all efforts to limit medically accurate health care information available to patients and exclude qualified providers from participating in the Title-X program.

Child-Targeted Gluten-Free Products No Healthier

July 23, 2018

Compared with child-targeted products without a GF claim, child-targeted GF products had lower levels of sodium, total fat, and saturated fat, and also had less protein, and a higher percentage of calories from sugar.

Can Omega-3 Fatty Acid Monotherapy Effectively Treat Adolescent Depression?

July 20, 2018

These results challenge existing conceptions that omega-3 fatty acids may be effective in treating adolescent major depressive disorder.

Zomacton Approved for Four Additional Pediatric Indications

By July 19, 2018

Previously, the product was approved for growth failure in children due to inadequate endogenous growth hormone (GH) secretion and for the replacement of endogenous GH in adults with GH deficiency.

Intelence Indication Expanded to Include Younger HIV Patients

By July 18, 2018

The approval of Intelence for this patient population was based on an open-label, single arm trial (N=20) which showed that the safety and efficacy of etravirine + an optimized background regimen (ritonavir-boosted protease inhibitor in combination with 1 or 2 NRTIs [N=14] and/or combination with an integrase inhibitor [N=7]) was comparable to that observed in adults.

Vigadrone Available for Refractory Complex Partial Seizures, Infantile Spasms

By July 16, 2018

Like Sabril, Vigadrone carries a Boxed Warning regarding the risk of permanent vision loss and is only available to healthcare professionals and patients under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program

Data Support FDA Restrictions on Child Cough and Cold Medicines

July 16, 2018

Surveillance data showed more adverse events for children exposed to hydrocodone than codeine

Harmful Internet "Challenges" and Teens: A Guide for Primary Care Providers

July 12, 2018

Discussions involving Internet challenges with children and adolescents should be as sensitive as those about sexuality and drug or alcohol use.

Parents Urged to 'Look Before You Lock' Cars

July 10, 2018

"These children don't have to die," KidsAndCars.org founder and president Janette Fennell said in a statement. "Parents and caregivers have the power to make sure that this doesn't happen to them."

Atypical Antipsychotic Use and CV Events in Youth: What's the Link?

By July 06, 2018

The retrospective cohort study involved a search of Medicaid claims of pediatric patients aged 5 to 20 years who were initiated on atypical antipsychotic medications.

Increase in Prevalence of Pediatric Hypertension With New Definitions

July 06, 2018

Incorporation of new pediatric definitions increased prevalence of hypertension in high-risk youth

Menkes Disease Treatment Granted Fast Track Status by FDA

By July 02, 2018

CUTX-101, a subcutaneous injectable formulation of copper histidinate, is designed to supplement blood and brain copper levels in patients with Menkes disease.

Novel Treatment for Primary Axillary Hyperhidrosis Gets FDA Approval

By June 29, 2018

The approval was supported by Phase 3 data from the ATMOS-1 and ATMOS-2 trials which evaluated the absolute change from baseline in sweat production after treatment with Qbrexza, and the proportion of patients who achieved ≥4-point improvement from baseline in their sweating severity (as measured by the Axillary Sweating Daily Diary [ASDD]).

Next-Generation Sequencing May Improve Pediatric Epilepsy Tx

June 29, 2018

By testing type, detection rates were 32.6% for the epilepsy-related gene panel, 44.8% for the clinical WES gene panel, and 17.3% for WES.

CDC: Updated Recommendations for Latent TB Infection Treatment

By June 28, 2018

In 2017, a Work Group was assembled to conduct a systematic review of 3HP regimen studies published between January 2006 to June 2017, specifically looking at outcomes in children, individuals with HIV/AIDS, and those who self-administered treatment.