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:
TAG: National Office Drug Safety Needed Experts Say JAMA

(Date:3/30/2015)... March 30, 2015 The partners of ... the grand opening of the Bella Diosa Laser Med ... the finest in laser med spa treatments. , February ... Spa and the partnership bridges the medical services provided ... treatments provided by Bella Diosa for both women and ...
(Date:3/30/2015)... NY (PRWEB) March 30, 2015 The ... has compiled the most frequently asked questions to give ... the process of egg donation. , After ... in early February, the IVF clinic has witnessed ... Tunçbilek, the reputable fertility center provides attentive reproductive care ...
(Date:3/30/2015)... Pearland, TX (PRWEB) March 30, 2015 ... trip to MedX Pharmacy. The staff of pharmacists is ... skin care issues like acne, eczema and other conditions. ... collaborate with a patient’s dermatologist and/or PCP to tackle ... compounding pharmacy, MedX Pharmacy has employed specialty-trained pharmacists who ...
(Date:3/30/2015)... 2015 In a recent report published ... Chris Christie is championing effective drug and alcohol treatment ... scrambling to recover funds to stabilize the addiction treatment ... victims of drug and alcohol addiction. Harbor Village Detox ... by substance use disorders in New Jersey, in hopes ...
(Date:3/30/2015)... San Jose, California (PRWEB) March 30, 2015 ... world population and government efforts to develop and establish ... pain management therapies. Growth in the market is poised ... pain as a result of the increase in chronic ... inflammatory diseases, and rheumatoid arthritis, among others. While conventional ...
Breaking Medicine News(10 mins):Health News:Yonkers Celebrates the Grand Opening of Bella Diosa 2Health News:Top Fertility Clinic in Cyprus Answers Key Questions on Egg Donation Process 2Health News:Top Fertility Clinic in Cyprus Answers Key Questions on Egg Donation Process 3Health News:Top Fertility Clinic in Cyprus Answers Key Questions on Egg Donation Process 4Health News:MedX Pharmacy Offers Skin Care Tips 2Health News:Harbor Village Detox Extends Addiction Treatment to NJ & Suggests 7 Ways to Find the Best Recovery Center 2Health News:Harbor Village Detox Extends Addiction Treatment to NJ & Suggests 7 Ways to Find the Best Recovery Center 3Health News:Technological Developments, Better Patient Awareness & Affordability Drive the Pain Management Devices Market, According to a New Report by Global Industry Analysts, Inc. 2Health News:Technological Developments, Better Patient Awareness & Affordability Drive the Pain Management Devices Market, According to a New Report by Global Industry Analysts, Inc. 3
(Date:3/30/2015)... YORK , March 30, 2015 ... based nurse call systems," announced the high level ... with the ClinicAll infotainment systems. The ... on patient entertainment terminals; this allows patients to ... on their need and acuity. The advanced functionality ...
(Date:3/30/2015)... CUPERTINO, Calif. , March 30, 2015 /PRNewswire/ ... announced that it has initiated a multi-dose Phase ... DUR-928, the lead molecule in DURECT,s Epigenomic Regulator ... entity (NCE) that may have broad applicability in ... (NAFLD) and nonalcoholic steatohepatitis (NASH).  It may also ...
(Date:3/30/2015)... 30, 2015  BioPharmX Corporation (OTCQB: BPMX), a ... novel drug delivery products to address unmet needs ... the appointment of Stephen Morlock , a ... its board of directors.  Mr. Morlock,s background will ... its national roll-out of Violet iodine, the new, ...
Breaking Medicine Technology:NiQ Health Announces CarePlus(TM) Integration with ClinicAll 2DURECT Announces Initiation of DUR-928 Multi-Dose Phase 1 Study 2DURECT Announces Initiation of DUR-928 Multi-Dose Phase 1 Study 3DURECT Announces Initiation of DUR-928 Multi-Dose Phase 1 Study 4BioPharmX Corporation Appoints Stephen Morlock To Its Board Of Directors 2BioPharmX Corporation Appoints Stephen Morlock To Its Board Of Directors 3
Cached News: