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.
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.
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(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
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Posted: March 2007