Roche Statement Regarding Tamiflu U.S. Label Revision

Main Category: Bird Flu / Avian Flu
Also Included In: Pharmacy / Pharmacist;  Regulatory Affairs / Drug Approvals
Article Date: 05 Mar 2008 - 0:00 PDT

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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.

Roche
Roche

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