Pharmacy Times

Concentration of Popular Flu Drug Lowered

Author: Kate H. Gamble, Senior Editor

The FDA has announced important product safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension on July 11. The agency worked with the manufacturer, Genentech (part of the Roche Group), to make these changes, which aim to reduce the possibility of prescribing and dosing confusion that can lead to medication errors.

The changes to Tamiflu oral suspension and the product label include: Genentech plans to begin distribution of the new 6 mg/mL product this month. The company has instituted a voluntary Take Back Program for wholesale buyers, distributors, and pharmacies to remove the 12 mg/mL product from the marketplace.

There are no quality issues with the 12 mg/mL product—it is still useable through its expiration date. However, FDA encourages participation in the Take Back Program to limit the potential for product confusion.

The 12 mg/mL product will remain in the marketplace and in state or national stockpiles until current supplies expire. Therefore, it is important for healthcare professionals to be aware that a patient may potentially receive either concentration (6 mg/mL or 12 mg/mL) from their pharmacy during the next influenza season (2011-2012). Steps should be taken to avoid the potential for a medication error due to confusion between the two concentrations.

For complete background information on Tamiflu, please click here.

Additional Information for Patients Additional Information for Pharmacies Click here to view the revised dosing chart for Tamiflu.