Oseltamivir, more popularly known by the brand name Tamiflu, is an influenza antiviral drug that has undergone controversy in the last few years. It’s a neuraminidase inhibitor that was approved by the FDA in 1999 after a number of trials, primarily funded Roche, showed a favorable efficacy profile with no major side-effects. Tamiflu seemed to be a godsend against pandemic flu, and in 2005 and 2009, flu season fears lead to Tamiflu recommendations by several regulatory organizations, including the CDC, the WHO, and the European Medicines Agency.
However, all was not right with the new medication. In 2007 a study in Japan found that the antiviral drug was associated with a significant increase in the occurrence of unconscious mind and a 50% increase in the risk of neuropsychiatric events in children. Japan was quick to restrict the drug’s use and include a warning on the package inserts for Tamiflu. Roche reviewed its data and declared that there was no increase in neuropsychiatric risk, but data continued to come from similar adverse events in other areas of the world.
In the meantime, case reports of abnormal behavior manifested in the United States, prompting the FDA in 2006 to require a warning insert for hallucinations, delirium, self-harm, and suicide.
Since then, studies have mostly found only ambiguous results, with data to murky to rule out or confirm these behavioral side-effects.
Recently a study by researchers from the University of Illinois at Chicago seems to suggest that Oseltamivir may be safe after all. Researchers used historical data to compare changes in mental state of children who received Oseltamivir for a flu diagnosis to children who had a flu diagnosis but did not receive Oseltamivir. They controlled for personal influencers of suicidal ideation by benchmarking the mental states of children to their mental states before the flu diagnosis at set intervals, establishing the metric as ‘overall change in mental health over the case of influenza infection as modified by Oseltamivir.’
The data showed no significant difference in changes of mental state between children taking Oseltamivir and those who were no prescribed the antiviral. This seems to suggest that Oseltamivir is safe to use in children, but it will likely take more evidence to convince the medical community that this is really the case.
The data showed no significant difference in changes of mental state between children taking Oseltamivir and those who were no prescribed the antiviral. This seems to suggest that Oseltamivir is safe to use in children, but it will likely take more evidence to convince the medical community that this is really the case.
-J. Cole Holderman
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