Tamiflu And Relenza Should Have Psychiatric Side Effects Warning, Say Regulators

Article Date: 24 Nov 2007 – 8:00 PDT

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.

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