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| T00-63 | Print Media: 301-827-6242 |
| November 20, 2000 | Consumer Inquiries: 888-INFO-FDA |
FDA today approved another indication for Tamiflu (oseltamivir phosphate), a neuraminidase inhibitor. Its new additional indication is for the prevention of influenza in adults and children 13 years and older. Tamiflu is an oral anti-viral drug previously approved by FDA for the treatment of uncomplicated influenza in adults.
In a pooled analysis of two seasonal prophylaxis studies in healthy unvaccinated adults and adolescents, Tamiflu 75 mg once daily taken for 42 days during a community outbreak reduced the incidence of laboratory confirmed clinical influenza from 4.8 percent for the placebo group to 1.2 percent for the Tamiflu group.
In a seasonal prevention study in elderly residents of nursing homes, 75 mg of Tamiflu taken once a day for 42 days reduced the incidence of laboratory confirmed clinical influenza from 4.4 percent for the placebo group to 0.4 percent for the Tamiflu group. Approximately 80 percent of this elderly population were vaccinated against the influenza.
In a study of post-exposure prevention in households, 75 mg of Tamiflu was given once daily within two days of onset of symptoms and continued for seven days. Results of this study show Tamiflu reduced the incidence of laboratory confirmed clinical influenza from 12 percent in the placebo group to 1 percent in the Tamiflu group.
Side effects from Tamiflu, when taken for prevention, were similar to those from patients who took the drug for treatment. The most common side effects were nausea, vomiting, headache, and fatigue. Efficacy of Tamiflu for the prevention of influenza has not been established in immunocompromised patients.
Patients should continue receiving an annual flu vaccination according to guidelines on immunization practices. Tamiflu is not a substitute for the flu vaccine.
Tamiflu is manufactured and distributed by Roche Pharmaceuticals, Inc. of Nutley, N.J. and Gilead Sciences, Inc., in Foster City, C.A.
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