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.
-J. Cole Holderman