Navigation Links
FDA Panel Backs Stronger Warning for Tamiflu
Date:11/27/2007

Advisers say current labeling doesn't reflect reports of bizarre behaviors and sudden deaths

TUESDAY, Nov. 27 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Tuesday that the prescription flu drug Tamiflu (oseltamivir) should have a strengthened warning label to reflect reports of bizarre behaviors and deaths among children.

The FDA's Pediatric Advisory Committee, in a 9-5 vote, said that drug maker Roche Holding AG should change its current prescribing information because it doesn't adequately explain side effects reported by hundreds of patients in Japan and the United States, according to Bloomberg News.

The drug's label mentions reports of delirium and self-injury, primarily among children in Japan, but the advisory panel said the language should state that several patients died as a result of these abnormal behaviors, the Associated Press reported.

In addition, the panel recommended that labeling for the flu drug Relenza, (zanamivir), should also reflect reports of bizarre behavior, according to Bloomberg.

The FDA is not obliged to follow its expert panels' recommendation, but it usually does. A safety review released Friday by the FDA's Division of Antiviral Products urged stronger label warnings for both drugs, including stricter monitoring of children taking these drugs.

According to the FDA safety review, there have been 596 reported cases of psychiatric behavior associated with Tamiflu use. Most of these cases happened among patients aged 21 or younger. The majority (75 percent) occurred in Japan.

Fifty-nine of the cases were classified as delirium with impulsive behavior and self-injury. Delirium, delusions, hallucinations or psychosis accounted for another 225 cases. In total, five children died "as a result of falls from windows or balconies or running into traffic," the safety review found, and three adults
'/>"/>

Copyright©2007 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Virginia Tech Review Panel Calls For Reform of Mental Health Treatment Law
2. CryoCor Invited to Participate in FDA Advisory Panel Meeting on Atrial Fibrillation
3. Patient Safety Authority Board of Directors Names Infection Advisory Panel
4. Partners Rx Chief Pharmacy Officer, Richard Bullard on Panel Discussion at the Fall 2007 Managed Markets Summit (MMS) in Phoenix, AZ.
5. Billians HealthDATA GM Speaking on Dreamforce 07 Panel
6. FDA Panel Recommends Approval of SyntheMeds REPEL-CV(R) Adhesion Barrier for Pediatric Patients
7. Abaxis Announces New Waived Kidney Check Panel Exclusively for Imaging and Radiology Centers
8. Health Courts Critic to be Featured Speaker at Wyoming Patient Safety Panel
9. FDA Panel Mulls Ban on Kids Cold Medicines
10. FDA Panel Weighs Ban on Kids Cold Medicines
11. FDA Panel Recommends Ban on Cold Medicines for Kids
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Panel Backs Stronger Warning for Tamiflu
(Date:12/25/2014)... Phoenix, AZ (PRWEB) December 25, 2014 ... comes to outstanding customer service and affordable quality regarding ... metropolitan area announces recognition in 2014 by the “Queen ... and Sons has earned an impressive reputation over the ... pricing on a wide range of contractor services for ...
(Date:12/24/2014)... 2014 Connie Casad, MD, a well-known ... advocate with 30 years of practice experience in Dallas, ... health benefits of dietary detoxification. The second study is ... excellent results from test patients who just completed a ... her interest in conducting the study, Dr. Casad said, ...
(Date:12/24/2014)... 2014 Dr. Vu Ho, a Dallas ... his practice and med-spa with the addition of new ... of cosmetic treatments and services. , “Silk Peel is ... says Dr. Ho. “As a result it can address ... sun spots, discolorations or blemishes.” , Similar to microdermabrasion, ...
(Date:12/24/2014)... December 25, 2014 The report “Stivarga ... focuses on the current treatment landscape, unmet needs, current ... Stivarga is a drug which is used in the ... orally administered and is also prescribed to patients who ... is FDA approved is a multi-kinase inhibitor and it ...
(Date:12/24/2014)... holidays can be a challenge for people who suffer migraines, ... "This is the season in which many people overindulge ... Dodick, chair of the American Migraine Foundation, said in a ... through food and beverage choices, to help reduce the risk ... neurology at the Mayo Clinic in Scottsdale, Ariz. , , ...
Breaking Medicine News(10 mins):Health News:Parker & Sons Announces Recognition In 2014 By The “Queen Of Clean” For Impressive Contractor Services In Arizona 2Health News:Parker & Sons Announces Recognition In 2014 By The “Queen Of Clean” For Impressive Contractor Services In Arizona 3Health News:Connie Casad, MD, Now Accepting Test Participants for January Dietary Detoxification Study 2Health News:Connie Casad, MD, Now Accepting Test Participants for January Dietary Detoxification Study 3Health News:Dr. Vu Ho Expands Facial Plastic Surgery Practice to Include New Skin Care Treatment 2Health News:Stivarga Colorectal Cancer Treatment Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 2Health News:Stivarga Colorectal Cancer Treatment Market Analysis and Forecast to 2023 Report at RnRMarketReserach.com 3Health News:Expert Offers Tips for Preventing Holiday Migraines 2
... at Oregon Health & Science University,s School of Dentistry ... controlling heart rate and blood pressure synthesize a molecule ... growth. The finding could someday play a significant role ... and high blood pressure. According to the National Institutes ...
... Pharmaceuticals today announced that Scott Jackson, chief executive officer, ... in San Francisco. Mr. Jackson will provide a ... development programs. The presentation will be held on ... A of the Marines, Memorial Club & Hotel. About ...
... Mandates Label Accuracy, Truth in Advertising and ... In response to misleading statements recently made ... Association,s Executive Director and CEO, David Seckman, ... leagues on steroid usage, which the Natural ...
... deadly for women and African-Americans, but the reasons long believed ... differences for such patients compared to their white and male ... of the journal Cancer . , The results present ... type, and stage of the disease upon diagnosis don,t account ...
... for Childhood Cancer Research (NCCCR), a newly established division of Nemours ... in Wilmington, DE, has secured $1,020,000 in external funding for awards ... ... January 8, 2009-- The research team at the Nemours Center ...
... may explain linguistic and cultural differences of native peoples , , ... two different waves of people migrated from what is now ... settlers in the Americas, a new report says. , ... came to North America via the Beringia landmass, which once ...
Cached Medicine News:Health News:OHSU School of Dentistry team discovers new molecule in blood-pressure control system 2Health News:Natural Products Association Advocates Strength of Dietary Supplement Law 2Health News:Why bladder cancer is deadlier for some 2Health News:Why bladder cancer is deadlier for some 3Health News:Why bladder cancer is deadlier for some 4Health News:Nemours Center for Childhood Cancer Research Receives Over $1 Million in Grants for Cancer Research in 2008 2Health News:Nemours Center for Childhood Cancer Research Receives Over $1 Million in Grants for Cancer Research in 2008 3Health News:Nemours Center for Childhood Cancer Research Receives Over $1 Million in Grants for Cancer Research in 2008 4Health News:First Americans Arrived on 2 Separate Paths 2
(Date:12/22/2014)... Research and Markets ( http://www.researchandmarkets.com/research/h3xm6q/us ) ... Blood Glucose Market" report to their offering. ... market insight focuses on the developments in the self-monitoring ... . Reimbursement analysis and the effects of competitive ... than 73 SMBG meters have been performed, based on ...
(Date:12/22/2014)... , Dec. 22, 2014  ConvaTec, a privately-held ... Moraviec has been appointed Interim Chief Executive Officer of ... Moraviec succeeds Ken Berger .  "The Board of ... in leading ConvaTec over the past three years," said ... of Directors.  "We are confident that the company is ...
(Date:12/22/2014)... , Dec. 22, 2014 /PRNewswire/ -- RXi Pharmaceuticals Corporation ... focused on discovering, developing and commercializing innovative therapies ... today issued the following open letter to shareholders ... Dr. Med. Sc. Dear RXi Shareholders, ... number of inaccurate statements posted on certain social ...
Breaking Medicine Technology:US Self-monitoring Blood Glucose Market 2ConvaTec Names Paul Moraviec Interim CEO Effective December 22, 2014 2RXi Pharmaceuticals Issues Open Letter to Shareholders 2RXi Pharmaceuticals Issues Open Letter to Shareholders 3RXi Pharmaceuticals Issues Open Letter to Shareholders 4RXi Pharmaceuticals Issues Open Letter to Shareholders 5RXi Pharmaceuticals Issues Open Letter to Shareholders 6
... , , WESTWOOD, Mass., Dec. ... of imaging cytometry instrumentation and the leading supplier of ... state-of-the art iGeneration line of imaging cytometers to include ... With the option of four excitation lasers chosen from ...
... ... is pleased to announce that Alexander von Perfall has ... (Logo: http://www.newscom.com/cgi-bin/prnh/20061026/RPLOGO ) , Alexander has 13 years ... experience, most recently as co-founder and Chief Network Officer ...
Cached Medicine Technology:CompuCyte Announces the Release of Four-Laser Imaging Cytometers 2Royalty Pharma Announces that Alexander von Perfall Joins Management Team 2
... units with hydrophobic PTFE membranes,Millex filter ... ideal for the sterilizing filtration of ... and for sterilizing or clarifying organic ... filter units are available with different ...
... -4C. 5.5 Cubic Ft. ... light. Manual push button ... Two shelves. In-door shelves ... thermostat. Magnetic gasket. Hermetically ...
... Water, The Simplicity personal water system is ... use bottled water. In addition to the ... bottled water, your laboratory applications may be ... absorbed from containers and cause water quality ...
The incorporation of a reverse osmosis (RO) system and an ultrapure water system into a single stand-alone tower provides numerous benefits to the busy laboratory....
Medicine Products: