Pediatrics

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

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

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

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.

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.

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.

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

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

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

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

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.

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.

FDA has approved a vaccine for preventing meningococcal disease in children.

An increase in febrile seizures in children following vaccination with Fluzone warrants further investigation, according to a report from FDA.

FDA approved spinosad (Natroba, ParaPRO LLC) Topical Suspension 0.9% for the treatment of head lice infestation in patients aged 4 years and older.

Top-selling pediatric OTC analgesic, cough and cold, allergy, and gastrointestinal liquid medications in the United States are plagued with highly variable and inconsistent dosing directions and measuring devices, according to a study published ahead-of-print on the Journal of the American Medical Association's website.

Researchers from the Cincinnati Children's Hospital Medical Center have demonstrated that the tumor necrosis factor-alpha inhibitor etanercept is associated with significant increases in height, weight, and body mass index in children with juvenile idiopathic arthritis, according to a study recently published in Arthritis & Rheumatism.

When it comes to pediatric therapy, children ?are not just small adults.? This was one of the dominant messages emerging from the recent National Institutes of Health, Division of AIDS, Forum to Promote TRIUMPH ? TB Research in Underserved Maternal and Pediatric Populations with HIV.

In 2009, the drug trend for children, a measure of prescription spending growth, increased 10.8%, driven by a 5% increase in drug utilization and higher medication costs, according to the Medco 2010 Drug Trend Report.

New molecular entity: Vigabatrin (Sabril) was approved as an adjunctive treatment of refractory complex partial seizures in adults who have responded inadequately to several alternative treatments; and as monotherapy for pediatric patients with infantile spasms.

A matched, case-control analysis demonstrated an association between the use of stimulant medications (used to treat attention-deficit/hyperactivity disorder [ADHD]) and sudden unexplained death in children and adolescents.

In response to the recent FDA warnings about an increased risk of suicidal ideation/suicide attempt among children and adolescents using antidepressants, investigators performed a meta-analysis to assess the efficacy and risk associated with antidepressants among pediatric patients.

Children who receive broad-spectrum antibiotics during their first year of life are at increased risk of developing childhood asthma.That was the conclusion of researchers who conducted a large, longitudinal, case-control study.

A single dose of ibuprofen provides better pain relief than acetaminophen or codeine for children requiring emergency treatment for musculoskeletal trauma, results of a randomized, controlled trial demonstrate.

A series of analyses offers no consensus on the safety of drug-eluting stents (DES) compared with bare metal stents. Depending on the study, DES either result in an increase in major adverse coronary events (MACE) or a decrease in subsequent need for coronary artery bypass graft (CABG) surgery and repeat percutaneous coronary intervention without an excess of adverse clinical events.