Flu / Cold / SARS Respiratory / Asthma Regulatory Affairs / Drug Approvals Tamiflu And Relenza Should Have Psychiatric Side Effects Warning, Say Regulators

Published: Saturday 24 November 2007

After receiving reports of patients experiencing delirium, psychosis and hallucinations, US FDA staff recommend that flu drugs, Tamiflu and Relenza should carry warnings about possible side-effects. Tamiflu is made by Roche Holdings, Relenza is made by GSK (GlaxoSmithKline).

Tamiflu (oseltamivir) is a pill, while Relenza (zanamivir) is inhaled.

Reports from Japan indicate that children, particularly, may have a higher risk of experiencing these psychiatric side effects after receiving the flu drugs. Tamiflu and Relenza are the most common medications used for the treatment of flu. Apart from the said side effects, there have also been reports of deaths.

The safety of these treatments come under review next week by a panel of experts. The FDA staff announced their recommendations today – they say the warning should be directed at patients of all ages, not just children. Whether the side effects and deaths were caused just by the drug(s), the flu virus, or the two together is not clear, they explain. They said it would be prudent to add information to the labeling, and added that the products will continue to be monitored. They did not go as far as suggesting that the use of the drugs should be limited.

Over the last few years governments throughout the world have been building up their stocks of Tamiflu as a precaution to a possible future mutation of the H5N1 bird flu virus, which could cause a serious flu pandemic. As recent concerns regarding Tamiflu have surfaced, its sales have lost some steam. Tamiflu sales are 62% lower this year when compared to 2006, while Relenza sales have dropped 7%.

read more at:  http://www.medicalnewstoday.com/articles/89734.php

Influenza drugs linked to psychosis

Sun Nov 25, 2007 8:20PM

The recent findings show that more than 600 individuals, mostly in their youth, have reported neuropsychiatric signs after taking Tamiflu; the rate was approximately 115 cases in patients taking Relenza.
Despite these results, FDA has refrained from adding a caution to current labels and recommending close monitoring of patients for abnormal behaviors like delirium or self-injury.
Many believe the labels should contain a stronger note indicating such behaviors may result in serious injuries, including death, in some adults and pediatric patients. This is while experts have not found evidence of a direct connection between the influenza drug and deaths.
Tamiflu (Oseltamivir) and Relenza (zanamivir), are FDA approved anti-viral drugs, which are used to prevent and treat influenza.

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