Navigation Links
Study: Communicating health risk is a risky task for FDA
Date:1/19/2012

The impact of efforts by the U.S. Food and Drug Administration to notify the general public and health care providers about unanticipated risks from approved medications has been "varied and unpredictable," according to a systematic review of published studies about FDA warnings and alerts over the last 20 years.

Although some communication efforts had a strong and immediate effect, many had little or no impact on drug use or health behaviors and several had unintended consequences, researchers report in the journal Medical Care.

"Communicating risk to large groups of people is a complex science," said study director G. Caleb Alexander, MD, associate professor of medicine at the University of Chicago. "But success or failure at this can have significant consequences. As such efforts become more and more common with the FDA's mandate to establish a more active surveillance system we will need a better understanding of how to make them work and where they can go wrong. And we need more and better studies of the successes and failures of this process."

The FDA has several standard tools to disseminate new evidence about drug safety. These include "Dear Healthcare Provider" letters to prescribers, "public health advisories" and "Safety Alerts" targeting the general public, and "black box warnings" added to a label when a drug's risks may be particularly severe or affect a large population. Despite numerous studies examining single alerts, advisories and label changes, no prior study has systematically examined the effect of these risk communications.

The researchers from the University of Chicago Medical Center, North Shore University HealthSystem, Johns Hopkins Medicine and Harvard Medical School combed through the literature on the topic. They screened 1,432 articles published between 1990 and 2010. Only 49 reports had a primary goal of assessing the consequences of FDA risk communications for prescription drugs.
'/>"/>

Contact: John Easton
John.Easton@uchospitals.edu
773-795-5225
University of Chicago Medical Center
Source:Eurekalert

Page: 1 2 3

Related biology news :

1. Study: Crop diversity myths persist in media
2. Study: Residential washers may not kill hospital-acquired bacteria
3. UF-led study: Invasive amphibians, reptiles in Florida outnumber world
4. Study: New process that can save at-risk cancer patients is effective and significantly less costly
5. Study: Severe low temperatures devastate coral reefs in Florida Keys
6. Study: Climate change to increase Yellowstone wildfires dramatically
7. Study: People at risk for panic buffered from stressor by high levels of physical activity
8. Study: Preventive use of one form of natural vitamin E may reduce stroke damage
9. Study: Wild Cuban crocodiles hybridize with American crocs
10. Smithsonian study: Stranding records are faithful reflection of live whale and dolphin populations
11. Study: Biodegradable products may be bad for the environment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... -- Nxt-ID, Inc. (Nasdaq: NXTD and NXTDW) ("Nxt-ID" ... m-commerce market, updates the "Wocket in Your Pocket" celebrity ad campaign, ... middleweight weight classes, Vinny Pazienza (PAZ). ... of Thrones actor Ciaran Hinds and Sons ... Katey Sagal have been cast in Bleed for This ...
(Date:9/18/2014)... PULLMAN, Wash. - Washington State University researchers have developed ... sediment to power waste cleanup in rural areas. ... lead to an inexpensive and quick way to clean ... treatment plants while reducing pollution. , Professor Haluk ... College of Engineering and Architecture discuss the system in ...
(Date:9/18/2014)... BUFFALO, N.Y. A sleep-promoting circuit located deep in ... deep sleep. Discovered by researchers at Harvard School of ... and Biomedical Sciences, this is only the second "sleep ... to be both necessary and sufficient to produce deep ... Neuroscience , the study demonstrates that fully half of ...
Breaking Biology News(10 mins):NXT-ID's Vinny Paz Celebrity Ad Wocket Update: Katey Sagal and Ciaran Hinds Attached to His Upcoming Movie 2NXT-ID's Vinny Paz Celebrity Ad Wocket Update: Katey Sagal and Ciaran Hinds Attached to His Upcoming Movie 3Researchers develop unique waste cleanup for rural areas 2No sedative necessary: Scientists discover new 'sleep node' in the brain 2
... of aging in the nematode model organism C. elegans has provided ... whether genes involved in aging in the worm have a similar ... colleagues of McGill University (Canada) report that inactivation of the gene ... in increased cellular fitness and prolonged lifespan in mice. ...
... below your eyes. If you don't snooze, you lose a ... can't regenerate as quickly, the mind can't learn new words, ... gain things: a bad mood and increased risk for diabetes, ... sleep deprivation can be so serious that some sleep scientists ...
... offers additional insight into the evolutionary process by ... including New York University Biology Professor Richard Borowsky, ... that albinism in both populations was linked to ... common form of albinism in humans. They observed ...
Cached Biology News:Evolutionary conservation of a mechanism of longevity from worms to mammals 2Clocking in Pillow Time without the Pillow 2Clocking in Pillow Time without the Pillow 3Genetic analysis of cavefish reveals more about evolution 2
(Date:9/19/2014)... Biotech companies make announcements illustrating ... systems and advanced Laboratory Instrumentation. Companies in focus today ... BDX ), Thermo Fisher Scientific Inc. (NYSE: ... RGDO ), Sangamo Biosciences Inc. (NASDAQ: SGMO ... BioSciences, Inc. (OTCQB: PBIO) ("PBI" or the "Company") today ...
(Date:9/19/2014)... Pfenex Inc. (NYSE MKT: PFNX), a clinical-stage ... difficult to manufacture proteins including biosimilar therapeutics, today announced ... Annual NewsMakers in the Biotech Industry conference in ... , chief executive officer of Pfenex, will provide an ... on Friday, September 26, 2014 at 10:00 a.m. EDT/7:00 ...
(Date:9/19/2014)... NC (PRWEB) September 19, 2014 ... Biobased Product Label for its Organic Cotton . ... product’s amount of renewable biobased ingredients meets or exceeds ... intermediate materials composed in whole or in significant part ... logo/label will allow our Organic cotton to be immediately ...
(Date:9/19/2014)... September 19, 2014 ... http://www.researchandmarkets.com/research/b2jxhs/micro_market ) has announced the addition of the  ...  report to their offering.       (Logo: ... one of the fastest-growing segments in the chromatography ... in 2013, and expected to reach $2.0 billion ...
Breaking Biology Technology:Medical Instrumentation Automation Advances for Biological Sample Preparation - Company Expects Q4 Revenue Impact from Newest Instrument Systems 2Medical Instrumentation Automation Advances for Biological Sample Preparation - Company Expects Q4 Revenue Impact from Newest Instrument Systems 3Medical Instrumentation Automation Advances for Biological Sample Preparation - Company Expects Q4 Revenue Impact from Newest Instrument Systems 4Medical Instrumentation Automation Advances for Biological Sample Preparation - Company Expects Q4 Revenue Impact from Newest Instrument Systems 5Medical Instrumentation Automation Advances for Biological Sample Preparation - Company Expects Q4 Revenue Impact from Newest Instrument Systems 6Medical Instrumentation Automation Advances for Biological Sample Preparation - Company Expects Q4 Revenue Impact from Newest Instrument Systems 7Pfenex to Present at Upcoming Industry Conference on September 26 2Barnhardt Manufacturing Company Earns USDA Certified Biobased Product Certification and Label for Organic Cotton 2Micro Market Monitor : Global Pre-packed Chromatography Columns 2
... ANGELES, Oct. 11, 2011 De Novo Software™, a ... solutions, and Nexcelom Bioscience, a leading supplier of cell ... announced today a licensing agreement enabling Nexcelom to distribute ...   Under the terms of the agreement, ...
... October 11, 2011 Edinburgh-based company 6S Ltd have ... service to store and retrieve digital media by replicating the simple ... patented technology is based on episodic memory - the memory which ... process of semantic tagging we are used to applying to digital ...
... inVentiv Health company, and a leading provider of physician ... today that it has changed its name to inVentiv ... organization – unveiled today at the Self-Insurance Institute of ... the company,s expanded solutions, revitalized mission and a commitment ...
Cached Biology Technology:Nexcelom Bioscience to Distribute FCS Express 4 Cytometry Software with Cellometer Vision CBA Instruments 2Digital Media Storage and Retrieval That Replicates the Functions of the Human Brain 2Digital Media Storage and Retrieval That Replicates the Functions of the Human Brain 3AWAC Becomes inVentiv Medical Management™ 2
Immunogen: Tissue / cell preparation. (Murine EHS laminin preparation) Storage: -20 C, Avoid Freeze/Thaw Cycles...
p-Raf-1 (Ser 338/Tyr 341)-R...
Rabbit polyclonal to Syntrophin alpha 1 ( Abpromise for all tested applications). entrezGeneID: 6640 SwissProtID: Q13424...
... between P-selectin and P-selectin glycoprotein ligand-1 (PSGL-1) ... the lumenal surface of endothelial cells at ... primary role of PSGL-1 in mediating the ... well documented.MAB4092 completely blocks recognition of PSGL-1 ...
Biology Products: