| Roche: No established causal link between Tamiflu and neuropsychiatric symptoms | Posted on 21/03/2007 in Pharmaceutical Company Product News Roche has announced that results from clinical studies and data collated from US and Japanese sources have shown that there is no established fundamental link between administration with Tamiflu and neuropsychiatric symptoms.
This announcement follows reports in Japan of patients with influenza who are taking Tamiflu suffering with delirium and other neuropsychiatric symptoms. The company notes that the ministry of health and welfare in Japan has confirmed that there is no causal link between these cases and the compound.
Additionally, data from health insurance records in the US have shown that patients administered with the drug have a lower risk of experiencing an adverse central nervous system event, including delirium, confusion and aggressive behaviour.
Eduard Holdener, chief medical officer of Roche, 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."
The company notes the serious nature of the potentially fatal influenza virus, with symptoms including fever of 40 degrees C or higher, severe malaise and in some instances, delirium and confusion.
Last month, Roche filed an application with the regulatory authorities in Europe for an extension of the existing license for Tamiflu to include 30 mg and 45 mg capsules to add to the already approved 75 mg capsule.Other news stories from 21/03/2007
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