Novartis defends data on its $2.1 million drug

August 12, 2019

While FDA recently said Novartis and AveXis did not reveal data on their $2.1 million gene thaerpy for pediatric spinal muscular atrophy until after it was approved, Novartis is defending its actions.

Pharma makers recall 2 important drugs

December 11, 2018

Two major drug recalls in the last week include an expanded recall of a widely used blood pressure medication as well as over-the-counter infant ibuprofen.

FDA wants certain OTC teething gels off the market

May 24, 2018

FDA is asking manufacturers to immediately stop selling OTC products containing the pain reliever benzocaine (such as Orajel) for teething in infants or children.

Training, advising pediatricians in antibiotic usage improves compliance with prescription guidelines

July 04, 2013

Educating pediatricians in their offices, auditing their prescription patterns, and leveraging a shared electronic health record, encourages them to choose more appropriate antibiotics for children with common respiratory infections, according to a study published in the June 12 issue of the Journal of the American Medical Association.

Newer whooping cough vaccines less effective than older vaccines

June 01, 2013

Teenagers who received DTaP (acellular pertussis vaccine) in their first 2 years of life had a 6 times higher risk of contracting pertussis compared with those who received DTwP (whole-cell pertussis vaccine) in their first 2 years of life, according to a study online in Pediatrics.

AAP publishes guidelines for managing pediatric C difficile infections

February 04, 2013

The American Academy of Pediatrics (AAP) has published a policy statement to provide pediatricians with recommendations for assessing and treating Clostridium difficile infections (CDI) in children.

2012 vaccination schedules published for children, adults

March 01, 2012

The 2012 vaccination schedules for children, adolescents, and adults have been released, with changes to the recommendations for meningococcal and human papillomavirus (HPV) vaccinations in children and in hepatitis B vaccinations in adults.

FDA Actions in Brief January 2012 (Antares, Isentress, REMS)

January 01, 2012

Recent FDA Approvals (through December 2011) related to (Antares, Isentress, REMS)

Children’s research discovery aids in adult cancer drug development

October 21, 2011

The recent approval by FDA of an adult cancer therapy is 1 example of how children’s cancer research benefits patients of all ages.

Topiramate reclassified as Category D due to potential link to oral clefts in newborns

June 01, 2011

FDA announced that it was reclassifying topiramate from a Pregnancy Category C to a Pregnancy Category D drug.

Birth defects risk appears low with newer-generation antiepileptics

May 27, 2011

First-trimester exposure to antiepileptic drugs compared with no exposure does not appear to increase the risk of major birth defects, according to a Danish study, published in the May 18 issue of the Journal of the American Medical Association.

Phase 3 trial finds infliximab effective in pediatric UC

May 20, 2011

Pediatric patients with moderately to severely active ulcerative colitis demonstrated a clinical response with infliximab (Remicade, Centocor Ortho Biotech), according to data from a phase 3 randomized, multicenter, open-label study.

Bile acid sequestrants show potential in children with familial hypercholesterolemia

May 13, 2011

The lipid-lowering efficacy and tolerability of bile acid sequestrants suggest that these agents have potential in pediatric patients with familial hypercholesterolemia, according to a recent literature review from the University of Chicago Pritzker School of Medicine.

PPI's efficacy and safety questioned for pediatric GERD

May 01, 2011

The effectiveness and safety of proton pump inhibitors for pediatric gastroesophageal reflux disease are far from proven, according to a new systematic review.

New treatment guidelines strongly endorse use of biologic agents for many children with arthritis refractory to methotrexate

May 01, 2011

The American College of Rheumatology has developed new guidelines for starting and monitoring treatments for children with juvenile idiopathic arthritis.

FDA lopinavir/ritonavir label change warns of serious health risks in premature babies

April 01, 2011

FDA notified healthcare professionals of serious health risks that have been reported in premature babies receiving lopinavir/ritonavir (Kaletra, Abbott) oral solution.

Lopinavir/ritonavir label change warns of serious risks in premature babies

April 01, 2011

FDA notified healthcare professionals of serious health risks that have been reported in premature babies receiving lopinavir/ritonavir (Kaletra, Abbott) oral solution.

Coadministration of flu, pneumococcal vaccine increases febrile seizure risk

March 11, 2011

Children aged 6 to 23 months who receive trivalent inactivated flu vaccine concurrently with the 13-valent pneumococcal conjugate vaccine are at increased risk of febrile seizures, according to researchers at the Centers for Disease Control and Prevention in Atlanta and Harvard Medical School in Boston.

Corticosteroids' safety affirmed in treatment of childhood asthma

March 04, 2011

Children being treated with a short course of oral corticosteroids for an acute asthma attack may experience a brief and transient depression of their immune response, according to a recent study conducted by Université de Montréal.