HOME >> MEDICINE >> NEWS
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
Rconn@wfubmc.edu
336-716-4587
Wake Forest University Baptist Medical Center
20-May-1998


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:
*Name:
*Comment:
*Email:


(Date:9/25/2017)... South Korea (PRWEB) , ... September 25, 2017 , ... ... those looking for a one-stop shop for the hottest Korean cosmetics and fashion trends ... move for a company that’s already well-known for the great offerings that allow Koreans ...
(Date:9/25/2017)... ... September 25, 2017 , ... “The Majestic Unicorn”: a poignant book that ... Unicorn” is the creation of published author, Dayna Chantel, an artist and a writer. ... wide to march aboard the cypress ark-vessel. Male and female, no matter what species, ...
(Date:9/25/2017)... , ... September 25, 2017 , ... Emerald Ash Borers kill Ash trees ... be seen throughout the Philadelphia region. A video by Rob Nagy, ISA Certified Arborist ... Ash trees. While several are dead or showing signs of decline from Emerald Ash ...
(Date:9/24/2017)... ... 23, 2017 , ... Throughout the United States and the world, clinicians take ... nurses and other providers work to give the best care possible to patients and ... U.S. Senators today are threatening to tie our hands in carrying out that oath. ...
(Date:9/24/2017)... ... September 24, 2017 , ... “Star of Bethlehem Study”: is a thought-provoking ... the creation of published author, Duane Engdahl, an investigator who had has a long ... Duane Engdahl’s new book is a thought-provoking essay an event so significant that it ...
Breaking Medicine News(10 mins):
(Date:9/7/2017)... -- For nearly two decades, New Life Agency has been committed to providing ... New Life Agency announces a powerful three-way partnership designed to deliver substantial ... ... http://www.schrafts2.com/ ... http://pharmacarecard.com/ (PRNewsfoto/PharmaCareCard) ...
(Date:9/7/2017)... Wash. , Sept. 7, 2017   BioLife Solutions ... manufacturer and marketer of proprietary clinical grade cell and tissue ... ("BioLife"), announces that Mike Rice , President and CEO, ... Rodman & Renshaw 19 th ... p.m. Eastern time (12:25 p.m. Pacific time). The conference is ...
(Date:9/6/2017)... -- NeuroRx, a clinical stage biopharma company developing the first ... been granted Fast Track status by the US Food and ... followed by NRX-101 (D-cycloserine + lurasidone). The company will shortly ... therapy targeting patients who are admitted to Emergency Departments with ... ...
Breaking Medicine Technology:
Cached News: