Navigation Links
Roche Statement Regarding Tamiflu U.S. Label Revision

NUTLEY, N.J., March 4 /PRNewswire/ -- Roche has informed healthcare professionals that the prescribing information for Tamiflu (oseltamivir phosphate) has been updated to reflect recommendations made by the FDA Pediatric Advisory Committee at a November 27, 2007 meeting regarding neuropsychiatric events. The revision is an update to a label change made in November of 2006 and includes information that influenza itself has been associated with a variety of neuropsychiatric events and that these reports appear to be uncommon.

The changes to the label reflect observations from a growing body of data, which shows no evidence of a causal relationship between Tamiflu and the reported events. The data shows that these neuropsychiatric adverse events also occurred in flu patients who were not taking Tamiflu. In fact, emerging evidence suggests that influenza itself may cause neuropsychiatric adverse events. In addition to clinical trials conducted prior to the approval of Tamiflu by the FDA, extensive post-marketing studies have been conducted and additional research is underway by Roche, Chugai and the Japanese health authority.

Roche agrees that it is important that healthcare professionals and patients know that all children with flu should be monitored, regardless of whether they are taking an antiviral medication. If any sign of unusual behavior is observed, a healthcare professional should be contacted immediately.

Antivirals like Tamiflu play an important role in the prevention and treatment of influenza. Tamiflu has been used by more than 48 million people worldwide, including nearly 21 million children, since its approval in 1999. Tamiflu is approved for the treatment and prevention of influenza in patients over one year of age and is one of two antiviral medications recommended by the CDC for the 2007-2008 influenza season.

Roche is committed to ensuring safe and appropriate use of our medications and will continue to conduct appropriate post-marketing monitoring and research.

For full U.S. prescribing information, please visit

Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Neurochem announces departure of two members of management team
2. Neurochem reports results for fourth quarter and fiscal year 2007 and important advances on corporate objectives
3. Press Statement: Roche Affirms That Tamiflu(R) is in Ample Supply Nationwide
4. Roche Completes Tender Offer for Ventana Shares
5. Neurochem to present at 2008 BIO CEO & Investor Conference - Presentation will be Web cast live
6. Roche Purchases Shares in Tender Offer for Ventana
7. Mayo Clinic Seeks Mitigation for Rochester as Condition of Canadian Pacific - DM&E Railroad Merger
8. Roche Plans to Complete Ventana Offer on February 7th
9. Neurochem appoints Mr. Gary Schmid as CEO of new nutraceutical business
10. Rochester Medical Announces First Quarter 2008 Earnings Conference Call February 4, 2008
11. Roche Engages in Four Additional AIDS Technology Transfers to Strengthen Local Manufacturing in Worlds Poorest Countries
Post Your Comments:
(Date:6/27/2016)... ... , ... recently awarded their highest five-star rating to Best Buy Eyeglasses, ... the United States and Canada wear eyeglasses. Once considered to be a purely functional ... a fashion statement. Even celebrities use glasses as a way of creating an iconic ...
(Date:6/26/2016)... , ... June 26, 2016 , ... PawPaws brand ... new product that was developed to enhance the health of felines. The formula is ... The two main herbs in the PawPaws Cat Kidney Support Supplement Soft ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery services, ... Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , Dr. ... skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was ...
(Date:6/25/2016)... ... ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors in ... School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green Hospital ... at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train in ...
(Date:6/24/2016)... Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... surgery procedures that most people are unfamiliar with. The article goes on to state ... procedures, but also many of these less common operations such as calf and cheek ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- Research and Markets has announced the addition ... - Forecast to 2022" report to their offering. ... to date financial data derived from varied research sources to ... potential impact on the market during the next five years, ... of sub markets, regional and country level analysis. The report ...
(Date:6/23/2016)... , June 23, 2016 , ... on Thursday, July 7, 2016 , , , , LOCATION: ... , , , , EXPERT PANELISTS:  , , , ... Senior Industry Analyst, Christi Bird; Senior Industry Analyst, Divyaa Ravishankar and ... The global pharmaceutical industry is witnessing an exceptional era. ...
(Date:6/23/2016)... , June 23, 2016  Guerbet announced today ... Inc.,s Supplier Horizon Award . One ... Guerbet was recognized for its support of Premier members ... through clinical excellence, and commitment to lower costs. ... receive this recognition of our outstanding customer service from ...
Breaking Medicine Technology: