November 14, 2006

Influenza Drug Tamiflu Linked to 'Neuropsychiatric Events' in Children

Roche, the manufacturer of the influenza ("flu") treatment medication, Tamiflu (oseltamivir phosphate), is warning of some rare but troubling possible side-effects when used in pediatric patients. Neuropsychiatric events such as impaired consciousness, abnormal behaviors, delirium, hallucinations, self-injury and delusions have been noted as adverse events in children being treated with Tamiflu, mostly in Japan, where hallucinations and other psychological and neurological symptoms in children have already been listed as adverse events on product labeling. Tamiflu prescriptions in Japan exceed those in the United States by about a factor of 10. These effects have been seen mostly in pediatric patients.

The United States Food and Drug Administration (FDA) staff had suggested updating Tamiflu's label to recommend that all patients, especially children, be closely monitored while on the drug.

Tamiflu is a treatment for influenza virus infections. Since severe cases of the flu can cause delirium, the FDA had not required the manufacturer, Roche AG, to add the warning because of the difficulty in determining how much the treatment for the flu was adding to the array of symptoms from the influenza infection itself.

So far there has been no information available as to how quickly these symptoms subside after discontinuation of the medication, nor if there are any additional concerns about Tamiflu's possible effects on children already with, or predisposed to, a psychotic disorder.

Roche AG is adding a warning to its labeling, which the FDA has approved.

If the child displays any of these neuropsychiatric events, the doctor should be contacted immediately.

Original Sources:

More information on the Influenza Virus and Preventative Vaccinations:
FDA Influenza Virus Vaccine U.S. FDA Center for Biologics and Research

More Reading on Infection/Immune System Links to Schizophrenia:
Infections as a causal factor in schizophrenia
Scientists: stronger link between cat virus and schizophrenia
Schizophrenia Linked to Immune System/Infection


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