Medications, especially those given to children, must be rigorously tested before being made broadly available. Still, once a medication is available to the general public, reactions and side effects may emerge that didn’t appear in testing.
Then the question must be asked and answered: is this an effect of the medication, an unknown factor (e.g., an undiagnosed condition in the patient or other medications they’re taking), or an effect of the illness itself? Most importantly, do the positive effects of this medication outweigh any potential side effects?
In the case of Tamiflu, new research is offering relief and good news for parents and children. The latest study data indicate that Tamiflu reduces, rather than increases, the risk of serious side effects.
Why Researchers Had Concerns About The Drug
Tamiflu, a brand name for the antiviral drug oseltamivir, is typically administered to patients who have been exposed to influenza. The CDC recommends antiviral treatments, particularly for people at high risk of complications from the flu, including pregnant women, patients with asthma or lung disease, and patients whose flu is severe enough to require hospitalization.
Tamiflu was approved in the U.S. in 1999, and a few years later, some doctors raised concerns about patients (children and adolescents) showing certain neuropsychiatric effects, including seizures, hallucinations, and reduced consciousness. However, they couldn’t say whether these effects were caused by the Tamiflu or by the flu itself.
The FDA responded to concerns at the time, saying that almost all cases of neuropsychiatric events had been documented in Japan; that that country’s treatment guidelines differed (however slightly) from U.S. treatment guidelines; and that there was no clear and definite link between Tamiflu and these reactions.
“In many of these cases, a relationship to Tamiflu was difficult to assess because of the use of other medications, presence of other medical conditions, and/or lack of adequate detail in the reports.”
The FDA issued warnings out of an abundance of caution but stressed that, in clinical trials, there had been no serious adverse effects.
New Research Confirms Tamiflu Safety
A long-running study examined outcomes among children treated with Tamiflu compared with those who were not during the 2016 to 2017 and 2019 to 2020 flu seasons. Now that the research has been published in JAMA Neurology, the results indicate that Tamiflu reduces the risk of neuropsychiatric effects.
Patients in the study were labeled as one of five categories: untreated flu patient (up to 10 days after diagnosis); patient currently recieving Tamiflu (a 5-day treatment); patients who have finished a course of Tamiflu but are still within the 10-day influenza period; patient given Tamiflu after exposure but did not deelop influenza; control group (neither flu diagnosis nor Tamiflu exposure).
The study found that the most common neuropsychiatric side effects in all flu patients were mood disorders, suicidal ideation, and self-harm behaviors, followed by a lower rate of seizures.
However, these side effects were lower among patients treated with Tamiflu than among untreated patients with influenza. Untreated influenza patients were almost twice as likely to experience these adverse effects as those treated with Tamiflu.
What Should Parents Take From This Study?
The total number of serious negative outcomes remains quite small among all study participants. However, the data suggest that Tamiflu is associated with a lower, rather than a higher, risk of seizures and other severe neuropsychiatric effects during a bout of influenza.
Parents who have worried about the safety of Tamiflu may breathe a sigh of relief, as current data suggest the antiviral will make their child safer and more likely to recover from the flu with fewer severe side effects.
However, as always, parents should consult their child’s physician and disclose any additional conditions and medications to provide the physician with the best information to make the most appropriate recommendation for that individual patient.