Chicago—More than a dozen years ago, the FDA added cautionary language for Tamiflu, based on reports of delirium, hallucinations, and other psychiatric behavior in Japanese pediatric patients.

As a result, every influenza season, pharmacists must field questions about the use of oseltamivir prescribed to children to shorten duration and reduce the risk of complications from the flu.

Now, a new study in The Annals of Family Medicine finds no increased risk of suicide in pediatric patients.

“When the FDA puts a warning out about a drug, doctors and the public take notice," explained corresponding author James Antoon, MD, assistant professor of clinical pediatrics at the University of Illinois Chicago College of Medicine. “While the warnings are necessary, they are often not based on conclusive clinical data, which can make it difficult for physicians to truly know the potential side effects of a drug as they evaluate its possible benefits for individual patients.”

Antoon and colleagues from the UIC College of Pharmacy retrospectively studied the association between the use of Tamiflu and suicide, the most detrimental of reported side effects. To do that, they identified 21,047 children between the ages of 1 and 18 who attempted suicide during five recent flu seasons (2009-2013) from a national administrative claims database. Of this group, 251 of those children were prescribed Tamiflu, which was determined based on outpatient pharmacy dispensing data. 

For the suicide group—majority female with a mean age of 15 years and 65% with an underlying mental health diagnosis—four earlier control periods were established to “account for within-person confounders, like depression, mental health, trauma and abuse, and other factors, like race or ethnicity,” Antoon notes.

The researchers repeated the analysis with a flu diagnosis alone to see if that could have been a confounding factor associated with suicide risk. The result? “We did not find any association between exposure to Tamiflu and suicide in pediatric patients,” Antoon said.

He advised that pharmacists and other healthcare professionals should remain alert regarding side effects related to oseltamivir, adding, “While this study addresses suicide, there are still many other questions about other possible neuropsychiatric side effects of the drug, which we plan to study in the future. There are also other reasons to use caution when prescribing the drug, including resistance and efficacy in children.”
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