Government approves new flu pill

3.24 a.m. ET (0724 GMT) October 28, 1999

WASHINGTON — Flu sufferers are about to get a second new drug that promises to ease miserable influenza symptoms a little this winter.

The Food and Drug Administration on Wednesday approved Tamiflu, the first pill effective against both types A and B flu. Tamiflu joins a competing but inhaled drug, Relenza, that the FDA approved earlier to also fight both flu types.

Health experts say neither drug should replace flu vaccines -- the shots clearly offer people a better chance at staying flu-free all winter. The flu kills 20,000 Americans a year, a toll doctors say would drop if more people got vaccinated.

But doctors also welcome the new treatments because so many Americans forgo vaccination.

Older flu medicines worked against only the type A flu, which accounts for about two-thirds of the estimated 20 million U.S. flu cases yearly, and doctors have said those medicines didn't work well.

Tamiflu, manufactured by Hoffmann-La Roche, helped reduce the duration and severity of flu symptoms in unvaccinated adults who agreed to be infected with influenza to test the drug.

Tamiflu is not a cure-all, the FDA warned. Studies showed taking the drug helped patients recover only about a day faster than flu patients who took a dummy pill, the agency said.

To get that benefit, patients took Tamiflu within 40 hours of the first flu symptom -- meaning patients would have to recognize flu symptoms and get to the doctor to get the prescription-only pill rapidly.

Side effects included nausea, vomiting, bronchitis, trouble sleeping and dizziness, the FDA said.

The FDA said Tamiflu has not yet been proved to prevent flu.

But a study published in today's edition of the New England Journal of Medicine suggests it might reduce the chances of catching flu if unvaccinated people took it daily during flu season.

Tamiflu, known generically as oseltamivir, was given to 520 people for the first six weeks of the 1997-98 flu season. Just 1 percent of them got the flu, compared with nearly 5 percent of a comparison group that took dummy pills, concluded University of Virginia researchers.

Hoffmann-La Roche spokesman Charles Alfaro said the drug would be available to customers within a month. A retail price has not been set.