- Safety & Recalls
- Regulatory Updates
- Drug Coverage
- COPD
- Cardiovascular
- Obstetrics-Gynecology & Women's Health
- Ophthalmology
- Clinical Pharmacology
- Pediatrics
- Urology
- Pharmacy
- Idiopathic Pulmonary Fibrosis
- Diabetes and Endocrinology
- Allergy, Immunology, and ENT
- Musculoskeletal/Rheumatology
- Respiratory
- Psychiatry and Behavioral Health
- Dermatology
- Oncology
Many drug labels missing safety, dosing information for children
Approximately half of drug labels don't have information on the medication's safety and proper dosing in children, according to a study from FDA researchers.
Approximately half of drug labels don't have information on the medication's safety and proper dosing in children, according to a study from FDA researchers.
In the study, researchers looked at 560 medications listed in the 2009 electronic Physicians' Desk Reference, some not relevant for pediatric use, and they found only 46% referred to children's usage. When they looked only at drugs used in children, they found "adequate" labeling information for 231 of 461 drugs. "Adequate" meant they included information on drug effectiveness, safety in kids and teens, and guidance on dosing.
Although this finding is an improvement in pediatric labeling, Debbie Avant, RPh, from the Office of Pediatric Therapeutics, Office of the Commissioner, FDA, told Formulary that the study reminds care providers and parents that many products still remain to be studied in children.
Some very vulnerable populations such as neonates remain almost untouched as far as developing adequate information on how best to use therapies in this population is concerned, Avant said.
"Obviously doctors need to use these therapies and would not withhold treatment, but it does emphasize that one should think about this aspect if a child is not responding or having unexpected adverse effects from a therapy," she said.
"Continued diligence in pediatric dosing for safety, as well as effectiveness, remains an inexact science due to the paucity of drug information available for clinicians or parents to review when choosing medications to use in children," Vogenberg continued. "This issue is likely to increase in importance as more narrow therapeutic margin medications enter the marketplace along with genomic-specific products in younger-age cohorts."
This study also evaluated the labeling of new molecular entities approved between 2002 and 2008 and determined that 41% had information on use in children.
For more information on the study of drugs in the pediatric population, go to http://www.fda.gov/AboutFDA/Transparency/Basics/ucm228249.htm. For pediatric labeling changes go to http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelingdatabase.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
