FDA addresses Tamiflu shortages

ATLANTA — The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

"The FDA is working hard to make sure that medicine to treat the flu and its symptoms are available for all who need it," FDA commissioner Margaret Hamburg told journalists during a conference call Friday. "Some locations may experience intermittent, temporary shortages of the oral suspension form of the antiviral, Tamiflu, which is the liquid version often prescribed for children for the remainder of the flu season. But the FDA has been working with the manufacturer, Genentech, to increase supply and is reminding healthcare professionals that FDA-approved instructions on the label provide directions for pharmacists on how to make a liquid form of Tamiflu from the Tamiflu capsules if the oral suspension product is not available."

Hamburg noted that Tamiflu 30-mg and 40-mg capsules remain available, and pediatric patients 1 year of age and older can be dosed correctly using the 30-mg and 40-mg capsules. "However, pediatric patients less than 1 year of age should be given Tamiflu oral suspension, preferably the commercial oral suspension product or if that isn't available, then the suspension prepared by the pharmacist according to the current label instructions," she said. 

While Tamiflu 75-mg capsules currently are available, supplies may run low if many pharmacies have to use the capsules to prepare an oral suspension for pediatric patients or to fill large numbers of prescriptions for adult patients, Hamburg acknowledged. "So to help avoid a shortage, the FDA is now allowing Genentech to distribute 2 million units of Tamiflu at the 75-mg capsule level that have an older version of the package insert," she said. "This additional supply is the same medicine as the product currently in distribution, but does contain an older version of the package insert — it's important to note that this medicine is fully approved. It is not outdated."

The older labeling doesn't have the new version of the instructions on making an oral suspension from the 75-mg capsules and new dosing information for treatment of pediatric patients two weeks to less than 1 year of age, Hamburg advised. 

Hamburg also updated reporters on developments in vaccine production. "In the last year time frame, FDA has approved four new vaccines," she said. "We have approved a new cell-based vaccine at the end of November, which is an important advance in terms of not depending on [eggs] and being able to enable a faster start for production. We have approved two qadrivalent vaccines that have the benefit of having two influenza A strains and two influenza B strains instead of just one influenza B strain. And we also … approved the first recombinant influenza vaccine."

Hamburg suggested that the increasing demand for the flu vaccine may help support the additional manufacturers and vaccine types that will be coming to market.