Navigation Links
Roche Statement Regarding Tamiflu U.S. Label Revision
Date:3/4/2008

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 http://www.tamiflu.com.


'/>"/>
SOURCE Roche
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:
*Name:
*Comment:
*Email:
(Date:1/24/2017)... ... January 23, 2017 , ... ... 140 Buzzies users who entered metrics into the product’s app. The data ... new data showed that within just 30 seconds of using Buzzies, people experienced ...
(Date:1/24/2017)... ... January 24, 2017 , ... The National Council of Alcoholism and Drug ... awareness, have worked with communities to designate the last full week of January as ... theme is “Shatter the Myths.” As a community, we can advocate for effective ...
(Date:1/23/2017)... CA (PRWEB) , ... January ... ... provider of translation and localization services for life science companies, has achieved ... inspection organization, TÜV SÜD America. ISO 17100 is the globally recognized standard ...
(Date:1/23/2017)... ... January 23, 2017 , ... ... training standards for healthcare treatment providers who treat the full spectrum of eating ... , The Presidents Council consists of the leading eating disorder treatments centers ...
(Date:1/23/2017)... , ... January 23, 2017 , ... Sharon Kleyne, America’s ... air to educate listeners about the benefits of making new water infrastructure a number ... said, “it’s appropriate that we expect water infrastructure to become a top priority of ...
Breaking Medicine News(10 mins):
(Date:1/24/2017)... YORK , Jan. 23, 2017 ... long way from conventional syringes with vials to ... systems. These modern devices have become preferred devices ... for prefilled syringes has been rising strongly over ... healthcare facilities are now adopting this format for ...
(Date:1/24/2017)... LONDON , Jan. 23, 2017 Scope ... Care Market with Focus on Intermittent Catheter Market (2016-2020)", ... market by value, by population, by product line. The ... market by value. The report provides a regional ... North America , Europe ...
(Date:1/24/2017)... COTTAGE, New York , January 23, 2017 /PRNewswire/ ... to Witness Sluggish Growth A ... are derived from formulating Active Pharmaceutical Ingredients (API), and ... propanol and propylene glycol. Production of pharmaceutical ... Asia-Pacific excluding Japan ...
Breaking Medicine Technology: