Science Current Events | Science News | Brightsurf.com
 
Email a Friend Send to a friend
Printer Friendly Print Post-marketing studies finding adverse events in drugs used in children
Slashdot It! Slashdot Post-marketing studies finding adverse events in drugs used in children
Submit to Reddit Submit Post-marketing studies finding adverse events in drugs used in children to Reddit
Reading: Post-marketing studies finding adverse events in drugs used in childrenTwitter This Reading: Post-marketing studies finding adverse events in drugs used in childrenTwitter Post-marketing studies finding adverse events in drugs used in children
Add to Facebook Add Post-marketing studies finding adverse events in drugs used in children to Facebook

Post-marketing studies finding adverse events in drugs used in children

September 02, 2008

DURHAM, NC -- The Food and Drug Administration Modernization Act (FDAMA, 1997), designed to stimulate more drug safety studies in children, has resulted in more than 130 label changes since its inception nearly six years ago, according to researchers at Duke Children's Hospital.

Their analysis appears in the September issue of Pediatrics.




Under this and subsequent renewal of this legislation, pharmaceutical companies were given a six-month extension of their exclusive marketing rights on a drug if they performed clinical trials requested by the FDA to determine the drugs' safety, dosing, and efficacy in children.

According to P. Brian Smith, MD, an assistant professor in Duke's department of pediatrics, many safety concerns cannot be detected until after the introduction of a product to a larger and more diverse population. The Best Pharmaceuticals for Children Act (2002) required the FDA to review and report to a public expert panel the adverse events occurring after granting pediatric exclusivity. That effort was needed because pediatric clinical trials are notoriously small, making it more likely that some safety concerns would not be detected until after the drug is used in a larger pediatric population.

Using MedWatch, the FDA's computerized information database for collecting reports of adverse events, the FDA's Pediatric Advisory Committee reviewed 67 drugs granted the extension. "This is a voluntary, cost-effective reporting system that can identify adverse events that may never have been seen in a clinical trial," Smith said.

"Just because a drug goes through testing and clinical trials does not mean its entire safety profile is known," says Danny Benjamin, MD, a co-author of the study and pediatrician at Duke Children's Hospital. "Before this incentive, there was no systematic, focused pediatric review of the data provided to the FDA's adverse event reporting system. Now, field experts in pediatrics are evaluating the data. That's what's so unique about this effort."

The majority of the 67 drugs studied (65.7 percent) did not appear to cause enough adverse events to require continued pediatric monitoring. However, nearly one in five drugs studied required label changes consisting of additional warnings and cautions for use in children, and several of the adverse events revealed during this process were considered life threatening. Some of those labeling changes included:

* Black Box warning and development of patient information for selective serotonin reuptake inhibitors (SSRIs) regarding potential for suicidality and neonatal toxicity/withdrawal syndrome.

* Box warning for transdermal opioid analgesis (Duragesic) alerting that inappropriate use may result in serious adverse reactions, including death.

* Labeling change for methylphenidate (Concerta) to address the potential for psychiatric events.

The Duke researchers say their findings support the approach that pediatric post-marketing surveillance is crucial, and that physicians, nurses, parents and others should take the job of reporting adverse effects seriously. Very rare serious adverse events are seldom defined during a study of a few hundred children and learning about these events is often dependent on the reporting of them from caretakers and parents.

"Unfortunately, few clinicians and patients know this reporting system exists," says Smith. "In the Duke Neonatal Intensive Care Unit, the pharmacist reports adverse drug events to MedWatch. But I'm not sure that happens at every hospital. A lot of physicians don't know it's available. This publication is somewhat of an advertisement that this program is available."

Smith urges parents to report adverse reactions they see. The FDA does not release any confidential information provided. Nor do the parents have to be certain that a drug exposure was the cause. It's the FDA's job to further investigate these events and any possible relationships to therapy, Smith said.

Duke University Medical Center





Science News and Science Current Events Tag Cloud
This tag cloud is a visual representation of term frequencies of random science news topics with common terms grouped together and emphasized by their display size.
Threatened Species   Conservation   Behavioral Problems   Telomeres   Cocaine   AIDS vaccine   Hibernation   Cerebral Palsy   Chromosomes   Lymphoma   Biomass   Juvenile Idiopathic Arthritis   Biosensor   Eczema   Vaccination   Rem Sleep   Dialysis   Satellite   Antimicrobial   Mitochondria   Immune System   Diet   Cochlear Implant   Clostridium difficile   Antarctic  
Related Pediatric Current Events and Pediatric News Articles Pediatric Current Events and Pediatric News RSS Pediatric Current Events and Pediatric News RSS
Lap-band weight-loss surgery can reverse metabolic syndrome in obese teens
A new study of obese adolescents has shown that laparoscopic gastric banding surgery -- the "Lap-Band" procedure -- not only helps them achieve significant weight loss but can also improve and even reverse metabolic syndrome, reducing their risk for cardiovascular disease and diabetes.

OJ Worse for Teeth than Whitening, Says Eastman Institute for Oral Health Researchers
With the increasing popularity of whitening one's teeth, researchers at the Eastman Institute for Oral Health, part of the University of Rochester Medical Center, set out to learn if there are negative effects on the tooth from using whitening products.

Infants should be screened for hip trouble
Developmental hip dysplasia is the most common congenital defect in newborns. The condition occurs when a hip joint is shallow, unstable or when the joint is dislocated. Infants with the condition are often at risk of developing arthritis of the hip as a young adult.

Gene expression findings a step toward better classification and treatment of juvenile arthritis
Scientists have discovered gene expression differences that could lead to better ways to classify, predict outcome, and treat juvenile idiopathic arthritis (JIA).

Genetic finding could lead to targeted therapy for neuroblastoma
Researchers have identified a genetic glitch that could lead to development of neuroblastoma, a deadly form of cancer that typically strikes children under 2.

Irritability should be considered when diagnosing bipolar disorder in children
A new study from Bradley Hospital and The Warren Alpert Medical School of Brown University, as well as two other institutions, adds to mounting evidence that clinicians consider irritability as a symptom when diagnosing pediatric bipolar disorder.

Study Characterizes Eczema Patients Most at Risk for Dangerous Viral Infections
Eczema patients at risk for serious viral infections have more severe disease, are more likely to be allergic to food and other allergens, and have a frequent history of staph infections.

ADHD genes found, known to play roles in neurodevelopment
Pediatric researchers have identified hundreds of gene variations that occur more frequently in children with attention-deficit hyperactivity disorder (ADHD) than in children without ADHD.

Meckel's diverticulum masked by intermittent recurrent subocclusive episodes
Meckel's diverticulum (MD) is the most frequent congenital abnormality of the small bowel and it is often difficult to diagnose.

Bypass surgery has long-term benefits for children with Kawasaki disease
Coronary artery bypass surgery provides long-term benefits for children whose hearts and blood vessels are damaged by Kawasaki disease, Japanese researchers report in Circulation: Journal of the American Heart Association.
More Pediatric Current Events and Pediatric News Articles
CURRENT Diagnosis and Treatment Pediatrics, Nineteenth Edition (LANGE CURRENT Series)

CURRENT Diagnosis and Treatment Pediatrics, Nineteenth Edition (LANGE CURRENT Series)
by William Hay (Author), Myron Levin (Author), Robin Deterding (Author), Judith Sondheimer (Author)

The Classic On-the-Go Guide to Pediatric Practice--Now More Current and Essential Than Ever!

CURRENT Diagnosis and Treatment: Pediatrics has long been the go-to guide for students, residents, and practitioners looking for concise, reliable, and up-to-date information. It continues to provide succinct, up-to-date, and clinically relevant coverage of how to assess and treat common disorders in children, from eating disorders and cardiovascular diseases to STDs.

Features:

Easy-to-follow LANGE CURRENT outline format: Problem, Essentials of Diagnosis and Typical Features, Clinical Findings, Differential Diagnosis, Treatment, Prognosis Organized by general topics such as care of the newborn and community pediatrics, as well as by organ system and specific...

ADSCOPE Animal Scope, Pediatric-22

ADSCOPE Animal Scope, Pediatric-22", Seafoam
by ADC

Adscope Animal scope, seafoam with 6 playful faces

Atlas of Pediatric Physical Diagnosis: Text with Online Access (Zitelli, Atlas of Pediatric Physical Diagnosis)

Atlas of Pediatric Physical Diagnosis: Text with Online Access (Zitelli, Atlas of Pediatric Physical Diagnosis)
by Basil J. Zitelli MD (Author), Holly W. Davis MD (Author)

Your best source for guidance on the visual diagnosis of pediatric disorders now comes to you in print and online! More than 3,400 hundred illustrations-3,000 in full color-capture the full range of gross anatomic signs as well as laboratory and radiologic findings for hundreds of pediatric disorders.

Addresses the entire spectrum of pediatric conditions-from pertinent historical factors and examination techniques to visual and diagnostic methods-providing you with comprehensive coverage for your toughest diagnostic challenges.
Features more than 3,400 practical, clinical photographs to help you identify and diagnose hundreds of pediatric disorders.

Features new, comprehensive coverage of malnutrition, obesity, and trauma to help you identify a wide range of...

Kolcraft Pediatric 2000 Mattress

Kolcraft Pediatric 2000 Mattress
by Sealy

Pediatric 2500 Mattress Perma Dri cover wipes clean with a damp cloth. This comes with 150 heavy gauge steel border rods for side, corner and edge support. This has two non allergenic soft sleeping layers for comfort and extra support. It comes with 10 year warranty on workmanship and materials. Kolcraft mattresses meet or exceed the current phthalates standards set forth by the CPSC and meet federal flammability standard 16 CFR 1633.

The 5-Minute Pediatric Consult (The 5-Minute Consult Series)

The 5-Minute Pediatric Consult (The 5-Minute Consult Series)
by M. William Schwartz (Editor), Louis M Bell (Editor), Peter M Bingham (Editor), Esther K Chung (Editor), David F Friedman (Editor)

The thoroughly updated Fifth Edition of this best-selling reference provides immediate, practical advice on problems seen in infants, children, and adolescents. More than 460 chief complaints and diseases are covered in the fast-access two-page outline format that makes The 5-Minute Consult Series titles so popular among busy clinicians. Other features include a medication index, syndromes glossary, surgical glossary, laboratory values, and tables. The Fifth Edition has new emergency department material including ingestion of caustics, opioids, and "ecstasy-type" drugs. New material on childhood obesity, metabolic syndrome, and probiotics is also included. A brand-new companion Website offers the fully searchable online text, plus selected full-color clinical photographs from...

Littmann 2119 Classic II S.E. Pediatric Stethoscope, Caribbean Blue

Littmann 2119 Classic II S.E. Pediatric Stethoscope, Caribbean Blue
by Littmann

Littmann Classic II S.E. Known as the standard in the industry, this performance stethoscope features the tunable diaphragm (Classic II S.E.) that allows both low and high frequency sound to be heard by simply alternating the pressure on the chest piece. The Classic II pediatric and infant stethoscopes feature the patented floating diaphragm technology. All models feature single-lumen tubing, nonchill rim, patented Littmann soft-sealing ear tips and three-year warranty. Classic II pediatric and infant style stethoscopes are optimally sized to facilitate sound sources in smaller patients.

Nelson Textbook of Pediatrics e-dition: Text with Continually Updated Online Reference (Nelson Textbook of Pediatrics (Bherman))

Nelson Textbook of Pediatrics e-dition: Text with Continually Updated Online Reference (Nelson Textbook of Pediatrics (Bherman))
by Robert M. Kliegman MD (Author), Richard E. Behrman MD (Author), Hal B. Jenson MD (Author), Bonita M.D. Stanton MD (Author)



Provides up-to-the minute coverage at www.nelsonpediatrics.com-updated multiple times a week-more frequently than any other source on the market!
Features the editorial contributions of a new editor-Dr. Bonita F. Stanton-for enhanced focus on general pediatrics.
Presents new knowledge on the principles of antibiotic therapy . antiviral therapy . antiparasitic therapy . antimycobacterial therapy . and others to improve your therapeutic skills.
Recommends which drugs and dosages to prescribe for every disease for full coverage of the principles of therapy.
Offers convenient reference through a new full-color design and full-color photographs that enable you to locate key content more easily and identify clinical conditions more quickly.

Features weekly updates at...

Clinical Pediatrics 2009

Clinical Pediatrics 2009
by Primary Care Software

Topics include: Adolescent medicine, Behavioral & Developmental issues, vaccinations, well child visits, fever work-ups, emergencies, PALS, pediatric syndromes, sleep disorders, GI, nephrology, urology, many orthopedic conditions, dehydration, dermatology, ENT, growth, puberty, routine examinations. Pediatric medicines and dosing. Neonatal care, breast feeding and much more.

Features: illustrations, references, hyperlinks and one year of free upgrades. Many detailed work-ups, differentials and treatment plans.

Edited by a Pediatrician with 25yrs of clinical experience.

This text contains numerous illustrations and is fully referenced.

No other text on the market provides such a collection of succinct and clinically relevant...

Pediatric Primary Care (Burns, Pediatric Primary Care)

Pediatric Primary Care (Burns, Pediatric Primary Care)
by Catherine E. Burns PhD RN CPNP FAAN (Author), Ardys M. Dunn PhD RN PNP (Author), Margaret A. Brady PhD RN CPNP (Author), Nancy Barber Starr MS RN CPNP (Author), Catherine Blosser MPA:HA RN APRN BC (PNP) (Author)

This fourth edition of Pediatric Primary Care is prepared to assist the pediatric healthcare provider to understand the wide spectrum of conditions seen in primary care of children. Written by experienced authors familiar with the scope of practice and knowledge base of pediatric nurse practitioners, it emphasizes prevention as well as management, and presents guidelines on assessing children from infancy through adolescence. The text is appropriate for nurse practitioner, medical, and physician assistant students as well as experienced clinicians who want a current pediatric primary care resource with easy access to information.

Management chapters include numerous tables to facilitate differential diagnoses and summarize management strategies.Resource boxes inform readers of...

ADSCOPE Animal Scope, Pediatric-22

ADSCOPE Animal Scope, Pediatric-22", Pink
by ADC

Adscope Animal scope, pink with 6 playful faces

© 2009 BrightSurf.com