FDA Mulls Tougher Warning Label on Kids' Flu Drugs

FDA Mulls Tougher Warning Label on Kids' Flu Drugs
TUESDAY, Nov. 27 (HealthDay News) -- A U.S. Food and DrugAdministration panel is meeting Tuesday to debate stronger warninglabeling for the prescription flu drug Tamiflu (oseltamivir), linkedrecently to anecdotal reports of bizarre behaviors and deaths amongchildren.
The FDA's Pediatric Advisory Committee will begin considering labelchanges to Tamiflu and another flu drug, Relenza (zanamivir), when used inchildren.
A safety review released Friday by the FDA's Division of AntiviralProducts does urge stronger label warnings for the medications, includingstricter monitoring of children taking these drugs.
One expert is concerned that the public may overreact, however.
"I am not a fan of replacing fear of a disease with fear of thetreatment for the disease," said Dr. Marc Siegel, a clinical associateprofessor of medicine at New York University School of Medicine in NewYork City. "You don't need to go from one panic to another," he added.
Tamiflu is overused, however, Siegel said. "It's supposed to be used ina very narrow window, and I am not surprised that there have beenpsychiatric side effects related to this drug," he said. "Maybe the newwarning will lead to less overuse," he said.
According to the FDA safety review, there have been 596 reported casesof psychiatric behavior associated with Tamiflu use. Most of these caseshappened among patients 21 or younger. The majority (75 percent) occurredin Japan.
Fifty-nine of the cases were classified as delirium with impulsivebehavior and self-injury. Delirium, delusions, hallucinations or psychosisaccounted for another 225 cases. In total, five children died "as a resultof falls from windows or balconies or running into traffic," the safetyreview found, and three adults committed suicide. So far, there haven'tbeen any such cases reported in the United States, according to theFDA.
The FDA began reviewing Tamiflu in 2005, and, since November 2006, thedrug's label has had a warning focused on self-injury and delirium. Thelabel also advises that patients be monitored during treatment. In Marchof this year, the Japanese Ministry of Health, Labor, and Welfare limitedTamiflu use in patients 10 to 19 years of age.
In their safety review, experts at the FDA advised the committee toamend the label warning to note that there were deaths in Japan related toTamiflu and to strengthen monitoring for patients taking the drug.
However, "A restriction on the use of oseltamivir in the U.S. does notseem warranted at this time based on the post-marketing data and the stillunanswered question about whether these events are due to oseltamivir,influenza/fever, or a combination of the two," the agency safety reviewsaid.
The maker of Tamiflu, Hoffmann-La Roche Inc., of Nutley, N.J., notedthat Tamiflu is used some six times more in Japan than in the UnitedStates. Moreover, whether the bizarre behavior observed is a result of thedrug or the flu itself remains unclear, the company said.
The company sees no need for a label change. "Thus, the information onneuropsychiatric events currently within the Precautions section of theTamiflu [label] continues to be an accurate assessment of all availableupdated and expanded data," it said in a report to the FDA.
Siegel believe a new warning is appropriate. "The idea that there havebeen 596 neuropsychiatric events is a reason for the FDA to put a strongwarning on the label," he said.
Millions of people have taken the drug, so the odds that any onepatient would have these reactions are very low, Siegel said. "People inhigh-risk groups achieve more benefit from the drug [against the flu] thanthey accrue risk for neuropsychiatric events," he said.
Tamiflu is approved both as a preventive and a treatment for flu foradults and children one year and older.
The FDA is also asking the committee to add a similar warning toanother flu drug, Relenza (zanamivir). There have been 115 reported casesof "delirium with impulsive behavior and self-injury in which the patientexpressed 'fear' and attempted to flee or expressed a desire to 'jump,' "the agency said. There were no deaths associated with Relenza, and, aswith Tamiflu, 70 percent of the cases occurred in Japan.
GlaxoSmithKline, the British maker of Relenza, doesn't believe thelabel needs changing. "The review and analysis of all the informationavailable in this safety summary of neuropsychiatric events does notimplicate or indicate a significant causal role of zanamivir. Therefore,no revisions are warranted for the U.S. Prescribing Information and theFDA-approved Patient Labeling for Relenza," the company told the FDA.
Relenza is approved as both a flu preventive and a treatment in adultsand children five years old and older.
In addition, the FDA reviewed side effects associated with two otherflu drugs Symmetrel (amantadine) and Flumadine (rimantadine). They arenot recommending any label changes for these drugs.
More information
For more on flu, visit the U.S. Centers for Disease Control and Prevention.