22 December 2005
FDA Approves Oseltamivir (Tamiflu) as Prevention against Influenza A and B for Children Over the Age of One (1) Year
Today the FDA posted on their website (www.fda.gov) the announcement of the FDA’s approval of the oral antiviral drug oseltamivir (Roche Pharmaceuticals drug name “Tamiflu”) for the prevention of both influenza A and influenza B in children 1-12 years of age.
Previously, this drug had only been approved for prevention purposes down to the age of 13 years. At the same time, oseltamivir (Tamiflu) had already been FDA-approved for treatment of actual symptomatic influenza illness down to the age of one (1) year. Now the age restrictions for children are identical for both prevention and treatment purposes of influenza A and B, namely all children over the age of one (1) year.
The clinical study on which FDA-approval for ages 1-12 years was based included 222 children in that age range out of a total of over 1100 people. Prophylactic doses of Tamiflu were given once daily for 10 days when someone in the household was diagnosed with the typical seasonal human influenza (this was NOT a study of avian H5N1 influenza A since that virus still does not spread easily from person-to-person).
The FDA reported that “The rate of children developing fever and other symptoms confirmed to be flu was reduced from 17% in the group receiving no preventive treatment to 3% in the group that received Tamiflu as a preventative measure”.
The most common side effects in this study were nausea, vomiting, headache and fatigue. Importantly, the FDA has requested further safety data post-marketing to evaluate the long-term safety of this drug. An FDA Pediatric Advisory Committee met on November 18, 2005 and the FDA required that the Tamiflu product label now include additional language regarding serious skin/hypersensitivity reactions.
Although not specifically mentioned by the FDA as playing a role in this new approval of Tamiflu for prevention of influenza in young children, this FDA approval calls to mind the October 24, 2005 FDA news release on their website titled “FDA Announces Rapid Response Team to Combat Pandemic (Avian) Flu”. Quoting the Acting FDA commissioner, Dr. Andrew von Eschenbach: ”Americans can be certain that FDA has the best scientific minds working together to ensure we have enough Tamiflu and other medications and to quickly get it to doctors and patients, if ever necessary”.
The October 24th FDA announcement regarding the Rapid Response Team for Pandemic (Avian) Influenza also stated that new medications for avian influenza could be made available under the FDA’s Emergency Use Authorization (EUA) provision. In addition, this team “will facilitate the development and availability of safe and effective vaccines that could help protect Americans against a future pandemic, including from avian flu”.
The FDA has made an important contribution by reviewing the safety and efficacy data for Tamiflu prophylaxis against influenza in children 1-12 years of age and approving the drug for this indication based on their review. In addition, the FDA Rapid Response Team to Combat Pandemic (Avian) Flu is also a welcome addition to optimize the options for accelerated preparedness against pandemic flu, both in terms of antiviral drugs as well as avian and pandemic flu vaccines.
May this potential for influenza preparedness FDA-regulatory agency partnerships with scientists, academics, pharmaceutical companies, and other US Federal agencies outside the FDA, be realized in practice in the months and years ahead.
Daniel R. Lucey, MD, MPH
Director, Center for Biologic Counterterrorism & Emerging Diseases
Washington Hospital Center Department of Emergency Medicine
Co-Director, Master of Science Program
Biohazardous Threat Agents and Emerging Infectious Diseases
Georgetown University School of Medicine, Washington, DC
Website:www.BePast.org; Email Daniel.R.Lucey@Medstar.net