Navigation Links
Better Ways Needed to Track Drug Safety: Report
Date:5/1/2012

TUESDAY, May 1 (HealthDay News) -- A management plan to gather, assess and respond to data about all medications' risks from the time they are approved until they are no longer on the market is needed to improve drug safety in the United States, says an Institute of Medicine report released Tuesday.

The U.S. Food and Drug Administration approves new drugs based on clinical trial evidence that their benefits outweigh their risks. However, the full range of a medication's effects may not become apparent until it is used by a larger, more diverse population over a long period of time, the FDA-sponsored report noted.

A number of drugs approved by the FDA were later found to have problems, including the pain reliever Vioxx, the diabetes drug Avandia and the cholesterol-lowering drug Crestor.

Report recommendations include:

  • The risk- and benefit-assessment and management plan for each drug should be a publicly available document that would gather data about the drug during its entire time on the market.
  • The document should describe known safety concerns at the time of the drug's approval or that become evident as it is used by consumers.
  • The document should also include all FDA regulatory actions taken on a drug, such as restrictions on its use or ordering a manufacturer to conduct further research after approval (postmarket research).

"It is not possible to know what the full range of a drug's benefits and risks will be until it is used by many different kinds of patients over time, so it is critical that FDA continues to monitor and learn about the effects of drugs after they are marketed," said report committee co-chair Ruth Faden, a professor of biomedical ethics and executive director of the Berman Institute of Bioethics, Johns Hopkins University, said in an Institute of Medicine news release.

The FDA already gathers much of this information but it is scattered across multip
'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Autism-Related Hypersensitivity Better Understood
2. Developing guidelines for better reporting of health research
3. Hawaiian-shirt.net Offers 10 Tips To Beat The Winter Blues: Things You Can Do Right Now to Have a Better Day
4. Better care at any hour for palliative patients
5. Patients Do Better at Hospitals That Follow Stroke Guidelines
6. More Expensive Hospital Care May Not Mean Better
7. New MRI May Lead to Better Brain Pictures
8. Biological clock could be a key to better health, longer life
9. Why do physicians order costly CTs? Ultrasound yields better diagnosis, safer, less costly
10. BetterInvesting Magazine Releases May Stock to Study and Undervalued Stock Choices for Investors Informational and Educational Use
11. New approach to immune cell analysis seen as first step to better distinguish health and disease
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
Better Ways Needed to Track Drug Safety: Report
(Date:7/13/2014)... Recently, iFitDress.com, one of the most famous dress ... of brown evening dresses for worldwide clients. ... discounted prices, up to 50% off. , All ... are carefully made according to most fashionable styles. In ... offers pretty accessories: wedding shoes, dancing shoes, sandals, boots ...
(Date:7/13/2014)... a professional supplier of funeral products. According to the company’s ... the global market. Recently, the company has announced its latest ... offer for all the newly released items. , Despite ... made with superb materials. As is commonly noted, a nice ... the departed saint. MillionaireCasket.com is always here to help. , ...
(Date:7/13/2014)... the best treatment and variations in the quality of ... blood cancer patients still varies widely between regions within ... in European adults to date, published in The ... 5-year survival for most cancers of the blood has ... the approval of new targeted drugs in the early ...
(Date:7/13/2014)... County, NC (PRWEB) July 13, 2014 ... of its newest location, the Carolinas HealthCare System - ... facility replaces the aged Anson Community Hospital in Wadesboro. ... is approximately three miles from the previous facility. Situated ... single-story floorplan that includes an emergency room drop-off, helipad, ...
(Date:7/13/2014)... Nature Genetics identifies a novel genetic and ... esophagitis (EoE), opening up potential new therapeutic strategies ... , EoE is a chronic inflammatory disorder of ... hypersensitivity to certain foods and an over-accumulation in ... (part of the body,s immune system). EoE can ...
Breaking Medicine News(10 mins):Health News:2014 Brown Evening Dresses Added To iFitDress.com 2Health News:Brand New Cherry Caskets Unveiled By China Casket Supplier MillionaireCasket.com 2Health News:The Lancet Oncology: Differences in treatment likely to be behind differing survival rates for blood cancers between regions within Europe 2Health News:The Lancet Oncology: Differences in treatment likely to be behind differing survival rates for blood cancers between regions within Europe 3Health News:Carolinas HealthCare System - Anson Hospital Now Open 2Health News:Study finds cause of mysterious food allergy, suggests new treatment strategy 2Health News:Study finds cause of mysterious food allergy, suggests new treatment strategy 3
... since 1959 , , TUESDAY, Nov. 25 (HealthDay News) ... the risk of chronic obstructive pulmonary disease (COPD), which ... U.S. researchers studied the job and health records of ... who worked on diesel trains (engineers, brakemen, conductors) were ...
... Good(TM) Campaign Reaches $1 Million Dollar Donation Goal and Collects ... , , NEW YORK, Nov. ... pleased to announce the donation of one million dollars to ... Against Hunger. The donation was made possible by the ...
... officials,convened today at a briefing hosted by the Pittsburgh ... recommendations of the Southwestern,PA Regional HIV/AIDS Needs Assessment study. ... insight and perspective on the impact of,the assessment,s findings ... Kathi Boyle, Executive Director of Pittsburgh AIDS Task Force, ...
... Of all the threats facing U.S. soldiers in combat, ... improvised explosive devices (IED,s). At the 61st Meeting of ... week in San Antonio, Naval Research Laboratory (NRL) scientist ... risk of traumatic brain injury for U.S. soldiers and ...
... FRANCISCO, Nov. 25 ECO2 Plastics, Inc.,(OTC Bulletin Board: ... plastics are recycled, today announced that it has received ... Administration (FDA), which,affirms the effectiveness of its proprietary waterless ... recycled plastic flake,to be used in food packaging applications. ...
... Margins Shrunk; Nearly Half Lost Money , , ... - 47 percent - posted overall losses at the end of 2007, ... the New Jersey Hospital Association,s Financial Status of New Jersey Hospitals report. ... Jersey,s hospital industry was on shaky financial ground long before the recent ...
Cached Medicine News:Health News:Weight Watchers Members and Online Subscribers Lose an Estimated 4 Million Pounds in Six Week Period 2Health News:Weight Watchers Members and Online Subscribers Lose an Estimated 4 Million Pounds in Six Week Period 3Health News:Weight Watchers Members and Online Subscribers Lose an Estimated 4 Million Pounds in Six Week Period 4Health News:Experts Address State of HIV/AIDS Care in the Region Following Landmark Assessment Showing Widening Gaps in Social Services 2Health News:Experts Address State of HIV/AIDS Care in the Region Following Landmark Assessment Showing Widening Gaps in Social Services 3Health News:Experts Address State of HIV/AIDS Care in the Region Following Landmark Assessment Showing Widening Gaps in Social Services 4Health News:The physics of explosives and blast helmets 2Health News:The physics of explosives and blast helmets 3Health News:ECO2 Plastics, Inc. Receives Favorable FDA Opinion Letter Approving the Use of Its Recycled Plastic Flake in Food Packaging Applications 2Health News:ECO2 Plastics, Inc. Receives Favorable FDA Opinion Letter Approving the Use of Its Recycled Plastic Flake in Food Packaging Applications 3Health News:NJHA: Hospital Finances Show Troubling Trends 2
(Date:7/11/2014)... , July 11, 2014 ... "Scintillator Market by Composition of Material, Application (Healthcare, ... others), End Product (Personal Instrument, Hand-Held Instruments, Fixed, ... and Analysis to 2013 - 2020", published by MarketsandMarkets, the ... CAGR of 5.62% from 2014 to 2020, and ...
(Date:7/11/2014)... 2014  Australian drug delivery company, Phosphagenics Limited (ASX: ... A$19.3 million via a placement of A$16.3 million to ... U.S., Asia and ... purchase plan (SPP) to be offered to existing shareholders. ... two tranches. "This capital raising positions us ...
(Date:7/11/2014)... , July 11, 2014 Research and ... of the "Immunoprotein Diagnostic Testing Market - ... highest CAGR of 6% and is expected to ... to their offering. ... diagnostic testing has been segmented according to immunoprotein ...
Breaking Medicine Technology:Scintillator Market will be worth $479.16 Million by 2020 2Scintillator Market will be worth $479.16 Million by 2020 3Scintillator Market will be worth $479.16 Million by 2020 4Phosphagenics' A$19.3 million Capital Raising 2Phosphagenics' A$19.3 million Capital Raising 3Immunoprotein Diagnostic Testing Market - Forecasts to 2019: Expected to grow at the highest CAGR of 6% and is expected to be valued at USD 4,943.0 million 2
... for individuals living with West Nile Virus and ... or immune compromised, PURCHASE, N.Y., Sept. 9 ... State University supported by the Division of,Vector-Borne Infectious ... (CDC) has demonstrated that AHCC(R) (Active Hexose Correlated,Compound) ...
... SAN DIEGO, Sept. 9 Ardea Biosciences, Inc.,(Nasdaq: ... presented on,the Company,s lead mitogen-activated ERK kinase (MEK) inhibitor, ... at,the Gaylord Palms Resort & Convention Center in Orlando., ... follows:, Date/Time: Tuesday, October 7, 2008 from 10:30 ...
Cached Medicine Technology:Study Demonstrates That AHCC(R) Provides Immune Enhancement Against the West Nile Virus 2Study Demonstrates That AHCC(R) Provides Immune Enhancement Against the West Nile Virus 3Ardea Biosciences to Present Data on Lead MEK Inhibitor, RDEA119, at American College of Gastroenterology Annual Scientific Meeting 2
For the qualitative detection of single and multiple drugs and drug metabolites in human urine...
For the qualitative detection of single and multiple drugs and drug metabolites in human urine...
For the qualitative detection of single and multiple drugs and drug metabolites in human urine...
For the qualitative detection of cardiac troponin I (cTnl) in human whole blood and serum specimens...
Medicine Products: