Children's influenza drug delayed

By Rhonda Rowland
CNN Medical Unit

NUTLEY, New Jersey (CNN) -- The maker of the only medication approved to treat both major strains of influenza in young children said the drug was not available for the start of this flu season because production problems delayed its distribution.

The medication, Tamiflu Oral Suspension product, was supposed to be launched this season, "so we were disappointed," said Charles Alfaro, a spokesperson for Hoffmann-LaRoche Inc., which makes the pediatric medicine.

"This has nothing to do with safety or efficacy of the product. This is a seasonal product and when we geared up production we noticed an issue and it's been resolved," Alfaro said.

Tamiflu pills for adults and older children were approved by the U.S. Food and Drug Administration in October 1999 and are available. The liquid formula for children 1 or older was approved in December 2000, but was not available until January 2001. Flu season usually occurs between December and March.

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Hoffmann-La Roche informed the FDA of its production problems in a letter dated January 4, but FDA spokeswoman Sharon Jayne said the company was not required to do so.

Studies show Tamiflu can shorten the duration of the flu by one to two days and reduce major complications such as ear infections and bronchitis. Ear infections, the most common complication in children, can be reduced by 44 percent. Reducing these complications means physicians can but back on the use of antibiotics, and even hospitalizations are reduced, doctors say.

A study released last month showed Tamiflu can reduce the spread of flu in families. When the first person in a household who developed the flu took the drug as well as all other family members, 63 percent of the households were protected against the flu.

"The results with this drug are dramatic," said Dr. Thomas Calk, a pediatrician with Children's Medical Group in Atlanta, Georgia. "Subjectively, patients have told me they feel better within a day or two of taking the drug."

Dr. Arnold Monto of the University of Michigan concurred. "I think it's very important to have Tamiflu for children," he said. "Flu vaccines are very good instruments but they're only 90 percent effective and we have vaccine failures even in high risk people. And not everyone gets a flu shot."

Tamiflu is one of two FDA-approved drugs in a new class of medications called neurominodase inhibitors, which attack the virus that causes the flu and stops it from spreading. The other medication, Relenza, is equally effective but can cause more side effects and is more difficult to use since it is inhaled twice a day. Both medications must be used within two days of developing symptoms to be effective.

Two other flu medications, amantadine and rimantadine, are available but only treat Influenza A. There is no rapid test available for use in physician's offices that can distinguish between Influenza A and B.

A prescription for Tamiflu costs about $80 and is covered by some insurance companies. According to the National Center for Health Statistics in 1999 there were 61,000 hospitalizations due to the flu. Records also show that flu in 1996 also accounted for more than 70 million lost work days more than 38 million lost school days lost.