Navigation Links
US Regulator Sees No Link Between Tamiflu And Japan Deaths

There is no evidence of a link between Tamiflu and the sudden deaths of 12 children in Japan who took the drug, The US Food and Drug Administration has concluded.

Roche, the Swiss pharmaceutical giant which markets the // drug standing in the front line of defense against a bird flu pandemic, agreed to work on changing the drug's labeling to warn of potential dermatological side-effects, reports AFP.

But the powerful US medicines regulator found unanimously that there was no 'causal link between pediatric deaths and neuropsychiatric adverse events and Tamiflu,' an FDA statement said after a hearing of its paediatric safety panel.

Roche said it 'intends to work with the FDA to change the drug's labeling based on adverse skin events that have occurred in a small number of patients, mostly in Japan.'

'We welcome the outcome of the FDA advisory committee and look forward to working with the FDA and other health authorities to extend our knowledge of the use of Tamiflu and its safety profile,' said William Burns, head of Roche's pharma division. 'The positive role of Tamiflu remains unchanged,' he added.

Reports in Japan have said Tamiflu may have been a factor in several suicides by children aged under 16 who took Tamiflu to treat influenza. The FDA has detailed 75 cases of mental and skin disorders worldwide, including 69 in Japan. The European Union's drugs agency has also asked Roche for a safety review into the drug.

Documents posted on the FDA website attributed increased reports of psychiatric disorders among Japanese children who have taken Tamiflu to a variety of probable causes. Those included increased awareness of flu-associated brain disease, increased access to Tamiflu in Japan, and an accompanying focus by the media and health regulators on potential side-effects.

Countries have placed huge orders for Tamiflu to guard against a feared pandemic of flu that could derive from the H5N1 avian influ
'"/>




Page: 1 2

Related medicine news :

1. Tumor Suppressor p53s Contradictory Regulatory System
2. A brush with the U.S. Regulators can cost a fortune
3. Cancer-causing Property Of Teflon Leaves US Regulators Concerned
4. Human Complexity Can Be Attributed To Regulatory Sequence
5. Regulators Object Drug Produced from Genetically Engineered Farm Animals
6. The Lancet Calls For Review Of Regulatory Process Of Drug Trials
7. Medtronic’s Insulin Pump Receives Regulatory Approva
8. Australian Drug Regulators Call for Revamp On The Pharmaceutical Surveillance
9. Drug Regulators Need To Think In Long-Term, Say Charities
10. Regulatory T-cells – Protector or Cause of Diseases
11. European Regulators Investigate Common Painkiller Drugs
Post Your Comments:
*Name:
*Comment:
*Email:
TAG: Regulator Sees Link Between Tamiflu And Japan Deaths

(Date:12/17/2014)... -- Expectant parents should leave prenatal picture-taking to medical ... Use of ultrasound imaging and heartbeat monitors to get ... agency warns. "Although there is a lack ... and heartbeat monitors, prudent use of these devices by ... FDA biomedical engineer, said in an agency news release. ...
(Date:12/17/2014)... HealthDay Reporter , TUESDAY, Dec. 16, ... America, and work commitment is a big reason why, new ... said Dr. Mathias Basner, an assistant professor of sleep and ... of Medicine. A time-use survey of nearly 125,000 Americans, ... main activity exchanged for sleep. Short sleepers -- those who ...
(Date:12/15/2014)... 15, 2014 South Florida’s leading urgent care ... can be a daze of hassle, hustle, and bustle that ... decking halls, to burns when making special meals and heartburn ... can happen at any time. To prevent this season of ... made a list of helpful and healthful holiday tips to ...
(Date:12/15/2014)... News) -- Expert pilots process visual information more efficiently ... better decisions during landings, a new study shows. ... pilots to master, and 36 percent of all airplane ... final approach and landing. Researchers monitored the brain ... pilots while they were at the controls of a ...
(Date:12/15/2014)... 15, 2014 At the leading, long-established ... AutismOne and Focus Autism will welcome ... research on the effects of toxins to children’s health, ... information. , Luminaries such as Dr. Lucija Tomljenovic ... with esteemed, credentialed colleagues of the United States to ...
Breaking Medicine News(10 mins):Health News:FDA Warns Against Fetal 'Keepsake' Videos 2Health News:Work Steals Valuable Sleep Time, Study Finds 2Health News:Work Steals Valuable Sleep Time, Study Finds 3Health News:MD Now Urgent Care Presents Healthy Holiday Tips 2Health News:MD Now Urgent Care Presents Healthy Holiday Tips 3Health News:Study Shows Why Expert Pilots Are Experts 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 2Health News:AutismOne and Focus Autism Collaborate on Scientific Conference; International Group of Researchers to Present in Chicago, May 2015 3
... Michigan Health System have been able to bring an ... from chronic obstructive pulmonary disease (COPD) by teaching them ... students are members of a pulmonary rehabilitation class at ... that people with chronic obstructive pulmonary disease can focus ...
... tiny gadgets, devices and machines can get, scientists have ... by a University of Arizona// team of optical sciences ... physics Alexander D. Cronin. ,Perreault and Cronin directly ... surface before the atoms' wavelengths change, said a statement ...
... present below the urinary bladder in males. The main function ... to the semen//. Prostate cancer is the most common cancer ... in American men. The incidence of the cancer in Asian ... an assessment of the risk factors is important. It is ...
... If you like to gorge on burgers and other ... have found a way to make it healthier//. ... and Molecular Biosciences and other researchers examined the properties ... in the Far East, South America and parts of ...
... Seasonal Affective Disorder (SAD) has been found to be affected ... emphasising the importance of sunlight for health//. ... in physical energy, increased appetite, and increased need for sleep. ... relation between melatonin and serotonin. ,Our mood is ...
... molecule is the cause of an autoimmune disease in ... disease is related to multiple sclerosis//. ,In a ... of Clinical Investigation, researchers from Johns Hopkins University School ... protein, IL-6, are dramatically elevated in the spinal fluid ...
Cached Medicine News:Health News:Nanotechnologists Specify Limitation For Devising Small Machines 2
(Date:12/15/2014)... , Dec. 15, 2014  Colorado and Washington ... legalized adult use of cannabis. Oregon , ... ended prohibition during the November 2014 elections. ... - http://photos.prnewswire.com/prnh/20141212/164153LOGO The benefits of ... and obvious benefits like the increased tax revenue for state ...
(Date:12/15/2014)... 2014   DaVita HealthCare Partners Inc.  (NYSE: ... largest and most innovative health care communities, today ... DaVita Clinical Research  (DCR) and  HealthCare Partners Clinical Research ... extensive clinical research and data analytics services, specifically ... end-stage renal disease (ESRD), as well as primary ...
(Date:12/13/2014)... , Dec. 11, 2014 Research and ... the addition of the "Drug Injection Devices ... http://photos.prnewswire.com/prnh/20130307/600769 ... of an expanding list of health conditions, drug ... that simplify the administration process and increase the ...
Breaking Medicine Technology:CannaInsider.com Estimates 200,000 New Jobs in the Cannabis Industry by 2015 2DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 2DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 3DaVita Clinical Research and HealthCare Partners Clinical Research to Merge and Expand Clinical Trials and Data Analytics Capabilities 4Drug Injection Devices to 2020 2Drug Injection Devices to 2020 3Drug Injection Devices to 2020 4
... of the leading cancer centers in the Middle East has ... RapidArc® radiotherapy treatments from Varian Medical Systems (NYSE: VAR). Al Amal Hospital ... and head & neck cancer patients with RapidArc since commencing treatments in ... many more indications. , , ...
... June 21 CardioGenics Holdings Inc. (OTC Bulletin Board: ... products for the immunoassay segment of the In-Vitro Diagnostics market, announced ... QL Care™ Analyzer, a portable diagnostic platform designed to produce test ... , , , ...
Cached Medicine Technology:Al Amal Hospital in Qatar Commences Treatments Using Fast and Efficient RapidArc Radiotherapy Technology from Varian Medical Systems 2Al Amal Hospital in Qatar Commences Treatments Using Fast and Efficient RapidArc Radiotherapy Technology from Varian Medical Systems 3CardioGenics Selects Clinical Test Sites for Its High Speed Portable Blood Analyzer 2CardioGenics Selects Clinical Test Sites for Its High Speed Portable Blood Analyzer 3CardioGenics Selects Clinical Test Sites for Its High Speed Portable Blood Analyzer 4
... information to facilitate diagnostic accuracy for appropriate ... sterile, disposable device used to inject fluid ... procedures. The device will measure the pressure ... a digital format. The physician can control ...
Maxi-Therm® hyper-hypothermia water blankets from Cincinnati Sub-Zero are designed for single-patient use. These blankets are easy to clean, stain resistant and ideal for isolation cases....
The Neuro-Cool™ System provides pain relief by combining a head wrap with a cold therapy unit for effective migraine treatment....
The ImmunoWELL Borrelia M Test is an enzyme immunoassay (EIA) for the qualitative and/or semiquantitative detection of Borrelia burgdorferi,IgM antibodies in serum and is used as an aid in the diag...
Medicine Products: