New Data from the US and Japan Support: No Established Causal Link Between Neuropsychiatric Symptoms and Treatment with Tamiflu US Databases Indicate Psychiatric Symptoms Lower in Influenza Patients Taking Tamiflu Versus Those Not Taking Tamiflu
BASEL, Switzerland, March 20, 2007 -- Clinical studies have shown (1) similar rates of neurologic and psychiatric events in pediatric influenza patients being treated with Tamiflu compared to those receiving no treatment for their influenza. Furthermore, recent data derived from US health insurance records (2) between 1999-2006 of over 101,000 influenza patients treated with Tamiflu and over 225,000 influenza patients not taking Tamiflu have shown that the Tamiflu treated patients showed a lower likelihood of experiencing a central nervous system (CNS) event such as delirium, delusion, confusion, hallucination, aggressive behaviour etc compared to those not receiving treatment (p<0.001). During the 2005/2006 influenza season the Japanese Ministry of Health Labor and Welfare coordinated a scientific study on the occurrence of influenza-associated symptoms. In accordance with previous clinical trials data the study reported no increase in neuropsychiatric events in patients with influenza receiving Tamiflu versus those not receiving the drug (3).
Influenza is a serious, sometimes life-threatening disease and the infecting virus gives rise to a number of unpleasant symptoms including a high fever (40 degrees or more), tender joints/limbs, severe malaise, a racking cough and in some cases delirium, confusion and general disorientation. Influenza associated delirium and neuropsychiatric disorders are not uncommon and occur in the United States in approximately 4 of every 100 000 influenza patients in the US, resulting in hospitalization (4). The incidence in Japan is believed even higher. A recent survey based on 1219 Japanese pediatric patients reported abnormal behavior in 1.7% of the patients (5). A second study reported 50 Japanese pediatric patients hospitalized for influenza. The most common reason for hospitalization was "abnormal behavior" (28%) (6).
Eduard Holdener, Roche's Chief Medical Officer, said: "Patient
safety is a primary concern for Roche and since the introduction of
Tamiflu, Roche has continuously monitored and reviewed
post-marketing safety information and provides regular updates to
the regulatory agencies".
Roche is aware that a number of reports have been received in Japan
of neuropsychiatric symptoms including delirium, with associated
abnormal behavior, and very rare cases of death in patients
suffering from influenza who have also been taking the antiviral
Tamiflu. The Japanese Ministry for Health and Welfare stated that
they see no causal relationship between these cases and
Tamiflu.
Tamiflu has now been used in over 45 million influenza patients worldwide (2) and treatment with Tamiflu has proven successful in reducing the duration and severity of the disease. Post marketing surveillance has confirmed that rates of neuropsychiatric events in patients with influenza also taking Tamiflu are uncommon, occurring in around 1 in 37,000 patients (2). In addition, reports of such events leading to death are extremely rare, occurring in around 1 out of every 5 million influenza patients treated (2). No causal link between such events and Tamiflu has been established.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As the world's biggest biotech
company and an innovator of products and services for the early
detection, prevention, diagnosis and treatment of diseases, the
Group contributes on a broad range of fronts to improving people's
health and quality of life. Roche is the world leader in
diagnostics and drugs for cancer and transplantation, a market
leader in virology and active in other major therapeutic areas such
as autoimmune diseases, inflammation, metabolism and central
nervous system. In 2006 sales by the Pharmaceuticals Division
totalled 33.3 billion Swiss francs, and the Diagnostics Division
posted sales of 8.7 billion Swiss francs. Roche employs roughly
75,000 worldwide and has R&D agreements and strategic alliances
with numerous partners, including majority ownership interests in
Genentech and Chugai. Additional information about the Roche Group
is available on the Internet at www.roche.com.
All trademarks used or mentioned in this release are protected by law.
Reference List
(1) Roche data on file. Clinical Study Report WV-15758
(2) Roche data on file
(3) Yokota S, et al. Cooperating Research Report 2006; MHLW;
Scientific Study on the Occurrence of Influenza-associated
Symptoms
(4) Newland JG, Laurich VM, Rosenquist AW, Heydon K, Licht DJ,
Keren R et al. Neurologic complications in children hospitalized
with influenza: characteristics, incidence, and risk factors. J
Pediatr 2007; 150(3):306-310.
(5) Hara K, et al. Clinical characteristics of children with
abnormal behavior associated with influenza infection. Nippon
Shonika Gakkai Zasshi 111(1) 38-44 (2007)
(6) Goshima N, et al. Clinical investigation on abnormal behaviors
in persons infected with influenza; Pediatric infection and
immunity, vol. 18 no..4, p 371-375
Roche Group Media Offic
Telefon: +41 61 688 8888 / E-Mail: basel.mediaoffice@roche.com
- Baschi Dürr
- Daniel Piller (Leiter Medienstelle Roche-Gruppe)
- Katja Prowald (Leiterin Wissenschaftskommunikation)
- Martina Rupp
Roche Group Media Office
F. Hoffmann-La Roche Ltd
Corporate Communications
Grenzacherstrasse 124
4070 Basel, Switzerland
Phone: +41 61 68 88888
Fax: +41 61 68 82775
mailto:basel.mediaoffice@roche.com
www.roche.com
Posted: March 2007
