National Office Of Drug Safety Is Needed, Experts Say In JAMA

sessment, with 10 additional slots.

Furberg, Moore and Psaty write that the new office should: Estimate the number and cause of serious injuries and death: No one at the FDA is routinely collecting such information, nor is anyone else in the government.

"It makes no more sense to monitor drug safety without knowing the extent of serious injuries than to have a National Highway Transportation Safety Administration that operated without information about automobile accidents or a Federal Aviation Administration (FAA) that does not know how many airplane crashes have occurred."

Identify new serious adverse reactions: The reports of adverse reactions are handicapped by limited physician participation, they say.

The FDA estimates that only 1 percent of adverse events are ever reported. For example, an average of 82 adverse reactions are reported each year for digoxin toxicity, which includes serious arrhythmias, but a systematic study of Medicare records found 202,211 hospitalizations in a seven-year period for digoxin-adverse reactions. Digoxin is prescribed for heart failure.

Some adverse reactions are disguised because an event might naturally be expected with the disease being treated. For example, it was hard to detect that flecainide -- a drug given for life-threatening ventricular tachycardia or fibrillation -- itself caused cardiac arrest.

Monitor the effectiveness of previous safety alerts: The FDA has no organized program to be sure that important warning messages are being communicated to doctors and the general public -- and whether they are being heeded. Even boxed warning labels have little effect.

"Safety monitoring should include surveillance of the most important known and expected risks and regular public reporting on the response of the public and prescribing physicians."

Operate an early warning system: The system would focus on the medical pr

Contact: Robert Conn
Wake Forest University Baptist Medical Center

Page: 1 2 3

Related medicine news :

1. National Academies advisory: May 2 Symposium on International Science Policy
2. National Academies News: William H. Foege to receive Public Welfare Medal, Academys highest honor
3. National Academies news: Academy honors 17 for major contributions to science
4. National Academies advisory: Report assesses health implications of perchlorate exposure
5. National Academies Advisory: Jan. 11 public briefing on perchlorate in drinking water
6. National Academies news: Gulf War and Health
7. National survey shows few physicians elected to Congress
8. Six new Roybal Centers for Applied Gerontology established by National Institute on Aging
9. UGA professor receives $3 million grant from National Cancer Institute for breast cancer research
10. National Academies advisory: Nov. 4-6 Frontiers of Science meeting in Irvine, Calif.
11. National Chemistry Week celebrates health and wellness in Washington, D.C., area

Post Your Comments:

(Date:11/27/2015)... ... November 27, 2015 , ... The rapid speed at which ... age, more care is needed, especially with Alzheimer’s, dementia and other cognitive conditions ... overworked. The forgotten part of this equation: 80 percent of medical care occurs ...
(Date:11/27/2015)... County, CA (PRWEB) , ... November 27, 2015 , ... ... season , The company is offering customers 10% off of their purchase of lice ... any treatment at full price. According to a company spokesperson. “Finding lice is a ...
(Date:11/27/2015)... (PRWEB) , ... November 27, 2015 , ... ... motto of progress through sharing, the 2016 Building Better Radiology Marketing Programs ... conference will begin on Sunday, March 6, 2016, at Caesars Palace in Las ...
(Date:11/27/2015)... ... November 27, 2015 , ... Keeping ... platform for mental health and wellness consultation, has collaborated with a leading web-based ... the knowledge gap experienced by parents and bring advice from parenting experts within ...
(Date:11/27/2015)... , ... November 27, 2015 , ... Avid collector, Andrew ... Arbor Michigan boxing style concert posters. This is one of Joplin's most famous and ... House at the University of Michigan in Ann Arbor. The According to Hawley, "It ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 26, 2015 Research and Markets ( ... "2016 Future Horizons and Growth Strategies in ... Shares, Country Segment Forecasts, Competitive Intelligence, Emerging Opportunities" ... --> --> This new ... Japanese therapeutic drug monitoring market, including emerging tests, ...
(Date:11/26/2015)... 26, 2015 Research and Markets ( http://www.researchandmarkets.com/research/92lrwg/advanced_wound ... Wound Care Market by Type (Dressings, Therapy Devices, Active ... Facility, Out-Patient Facility), and Geography - Global Forecast to ... --> --> The purpose of ... forecast of the global advanced wound care market. It ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "Radioimmunoassay Market ... User (Hospital, Pharmaceutical Industry, Academics, Clinical Diagnostic ... - Global Forecast to 2020" report ... ) has announced the addition of the ...
Breaking Medicine Technology:
Cached News: