Navigation Links
Post-marketing studies finding adverse events in drugs used in children
Date:9/1/2008

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 pediatr
'/>"/>

Contact: Debbe Geiger
Debbe.Geiger@duke.edu
919-660-9461
Duke University Medical Center
Source:Eurekalert

Page: 1 2 3

Related medicine news :

1. Gene Studies of Male-Female Differences Often Flawed
2. Two studies published in the Lancet
3. Study of Studies Finds No Risk to Children From Phthalates in Toys
4. Just Completed Studies Reveal Impact of New Medicare Reimbursement Regulations
5. Studies Prove Exercise Can Heal the Body Mind and Soul
6. Studies Shed New Light on Breast Cancer, Treatment
7. Multi-Year Compendium of Pharmaceutical Case Studies Available from Best Practices, LLC
8. Genomic Health Announces Multiple Studies on Oncotype DX(TM) Presented at 2007 American Society of Clinical Oncology (ASCO) Breast Cancer Symposium
9. Best Practice Database: Complimentary Excerpt of Three Sales Force Excellence Studies
10. Major Pharma Clinical Case Studies From Amgen, AstraZeneca, GSK, Intermune, Cephalon Inc, Sunesis Pharmaceuticals and Dartmouth Medical School During Fall Clinical Focused Programs
11. NIH awards Einstein multimillion dollar grant to extend studies of exceptional longevity
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/30/2014)... HealthDay Reporter MONDAY, ... should be the first choice of birth control for ... Pediatrics state. Although most U.S. teens opt for ... contraception -- intrauterine devices (IUDs) and contraceptive implants -- ... And they should be the "first-line" choices for teenage ...
(Date:9/30/2014)... 2014 Houstonians seeking the latest information ... visit on the Internet. Paul Vitenas, JR. M.D., ... cosmetic surgeons, has launched a new website to better ... Botox Cosmetic services. The new website can ... to the new website, Botox Cosmetic is a non-surgical ...
(Date:9/30/2014)... 2014 Thanks to generous ... Children’s Oral Health Foundation: America’s ToothFairy® (NCOHF) ... non-profit clinical partners. These organizations are part ... comprehensive educational, preventive and treatment services for ...     Just Kids Dental: $25,000 America's ...
(Date:9/30/2014)... News) -- For millions of overweight Americans, regular exercise ... threat of type 2 diabetes. However, a new ... some than for others, depending on their genes. ... not be as effective for everyone when it comes ... expert, Dr. Ruth Loos, director of the Genetics of ...
(Date:9/30/2014)... California (PRWEB) September 30, 2014 The ... to reach USD 38.75 billion by 2020 at an ... to a new study by Grand View Research, Inc. ... due to lifestyle habits such as excessive alcohol consumption ... organ failure rates is expected to serve this market ...
Breaking Medicine News(10 mins):Health News:Pediatricians Endorse IUDs, Implants for Teen Birth Control 2Health News:Pediatricians Endorse IUDs, Implants for Teen Birth Control 3Health News:Dr. Paul Vitenas Launches New Website To Showcase The Benefits Of Botox Cosmetic 2Health News:Dr. Paul Vitenas Launches New Website To Showcase The Benefits Of Botox Cosmetic 3Health News:America's ToothFairy Awards More Than $150,000 in Grants to Save Young Smiles 2Health News:America's ToothFairy Awards More Than $150,000 in Grants to Save Young Smiles 3Health News:Can Exercise Prevent Type 2 Diabetes? Your Genes May Be Key 2Health News:Global Artificial Organ & Bionics Market Is Expecting Growth At CAGR Of 40.0% In Brain Bionics Segment From 2014 To 2020: Grand View Research, Inc. 2Health News:Global Artificial Organ & Bionics Market Is Expecting Growth At CAGR Of 40.0% In Brain Bionics Segment From 2014 To 2020: Grand View Research, Inc. 3Health News:Global Artificial Organ & Bionics Market Is Expecting Growth At CAGR Of 40.0% In Brain Bionics Segment From 2014 To 2020: Grand View Research, Inc. 4Health News:Global Artificial Organ & Bionics Market Is Expecting Growth At CAGR Of 40.0% In Brain Bionics Segment From 2014 To 2020: Grand View Research, Inc. 5Health News:Global Artificial Organ & Bionics Market Is Expecting Growth At CAGR Of 40.0% In Brain Bionics Segment From 2014 To 2020: Grand View Research, Inc. 6
... , , WASHINGTON, July 20 ... of the people who were infected with the virus were able ... others. Recent studies have begun to unravel the cause of this ... have a unique survival advantage if they have both a low ...
... , , , BEDFORD, Mass., ... leader in tubing-free insulin pump technology with its OmniPod(R) Insulin Management ... quarter 2009 on Tuesday, August 4, 2009 after the close of ... will also host a conference call at 5:00 p.m. Eastern Time ...
... , PORTLAND, Ore. July 20 Studies ... for heart disease, stroke, and delivery of premature or low birth-weight babies. ... without dental insurance - nearly twice the rate of people without medical ... care more accessible to people, Regence Life and Health ...
... growth, metastasis, researchers say , MONDAY, July 20 (HealthDay ... may contribute to aggressive breast cancer, new research shows. ... profiles" of breast cancer tumors, researchers from the Genome ... be implicated in the development of breast cancer. , ...
... , , GREENFIELD, Wis., July ... one-of-a-kind online nutritional service and meal-planning program for cancer patients. ... www.therapeasecuisine.com . Founded by cancer survivors, the program ... registered dietitians. It is available to cancer patients and health ...
... ,The team, led by Professor Matthias Mann ... of Copenhagen and the Max Planck Institute for Biochemistry in ... "This is more than just a technological achievement, ... by a factor of six, and it gives us for ...
Cached Medicine News:Health News:Genetic Variation Associated With Survival Advantage in African Americans With HIV 2Health News:Genetic Variation Associated With Survival Advantage in African Americans With HIV 3Health News:Genetic Variation Associated With Survival Advantage in African Americans With HIV 4Health News:Insulet Corporation to Report Second Quarter 2009 Financial Results on Tuesday, August 4, 2009 2Health News:More Americans Have Cell Phones Than Dental Coverage 2Health News:New Gene May Signal Aggressive Breast Cancer 2Health News:Cancer Survivors Launch New Company, TherapEase Cuisine 2
(Date:9/30/2014)... is evident from the industry players that as a whole ... to the lack of promotional activities to make consumers aware ... acids. Among omega-3 ingredient sources algal oil is expected to ... vegetarian population in India . ... in growth stage of its lifecycle. Omega-3 fatty acids have ...
(Date:9/30/2014)... CytRx Corporation (NASDAQ: CYTR ... in oncology, today announced the initiation of a ... to topotecan in subjects with extensive-stage small cell ... refractory to prior chemotherapy. Aldoxorubicin is CytRx,s modified ... has received Orphan Drug Designation for the treatment ...
(Date:9/29/2014)... SAN DIEGO , 29 septembre ... désignée Daiichi Sankyo) (TSE : 4568) et Ambit Biosciences ... d,un accord de fusion définitif en vertu duquel ... actions ordinaires en circulation d,Ambit Biosciences à 15 ... d,une offre publique d,achat qui sera suivie d,une ...
Breaking Medicine Technology:Omega-3 Polyunsaturated Fatty Acids (PUFAs) - An Indian Market Overview 2CytRx Initiates Global Phase 2b Clinical Trial of Aldoxorubicin for the Treatment of Relapsed/Refractory Small Cell Lung Cancer 2CytRx Initiates Global Phase 2b Clinical Trial of Aldoxorubicin for the Treatment of Relapsed/Refractory Small Cell Lung Cancer 3CytRx Initiates Global Phase 2b Clinical Trial of Aldoxorubicin for the Treatment of Relapsed/Refractory Small Cell Lung Cancer 4CytRx Initiates Global Phase 2b Clinical Trial of Aldoxorubicin for the Treatment of Relapsed/Refractory Small Cell Lung Cancer 5Daiichi Sankyo va acquérir Ambit Biosciences 2Daiichi Sankyo va acquérir Ambit Biosciences 3Daiichi Sankyo va acquérir Ambit Biosciences 4Daiichi Sankyo va acquérir Ambit Biosciences 5Daiichi Sankyo va acquérir Ambit Biosciences 6Daiichi Sankyo va acquérir Ambit Biosciences 7Daiichi Sankyo va acquérir Ambit Biosciences 8Daiichi Sankyo va acquérir Ambit Biosciences 9
... HealthCare presented results from a global Phase II study ... detection of cerebral beta-Amyloid plaques, at the 19th World ... of the Phase II study was to investigate the ... clinical diagnosis of probable Alzheimer,s disease and Healthy Volunteers ...
... ADA,s 2009 Convention -- When Shawnae Jebbia won the ... a fairytale career. She appeared at events throughout the world, ... But Shawnae,s world unexpectedly changed when she was diagnosed with ... adventure, she had a difficult time understanding and accepting the ...
Cached Medicine Technology:Bayer HealthCare Presents Florbetaben Phase II Study Results at World Congress of Neurology 2Bayer HealthCare Presents Florbetaben Phase II Study Results at World Congress of Neurology 3Former Miss USA Shawnae Jebbia Shines with Siemens Pure 2Former Miss USA Shawnae Jebbia Shines with Siemens Pure 3
The Snap-In Snap-Out-II Tip Inserts offer a large variety of configurations....
This is a single-action instrument that features a spring handle....
The Snap-In Snap-Out-II Tip Inserts offer a large variety of configurations....
The Snap-In Snap-Out-II Tip Inserts offer a large variety of configurations....
Medicine Products: