Drug Safety and Availability > FDA Drug Safety Communication: Important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension

The U.S. Food and Drug Administration (FDA) is informing the public of important product safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension. These changes are being made to reduce the possibility of prescribing and dosing confusion that can lead to medication errors. FDA has worked with the manufacturer, Genentech (part of the Roche Group), to make these changes.

The changes to Tamiflu oral suspension and the product label include:

* A change to the concentration of Tamiflu from 12 mg/mL to 6 mg/mL. The lower concentration of Tamiflu is less likely to become frothy when shaken, which helps to ensure an accurate measurement. The 12 mg/mL concentration will no longer be marketed after current supplies run out.
* A change in the measurements of the oral dosing device from milligrams (mg = weight) to milliliters (mL = volume).
* A change in the dosing table table for Tamiflu to include a column for the volume (mL) based on the new 6 mg/mL concentration.
* Revised container labels and carton packaging.
* Revised compounding instructions for pharmacies to prepare a 6 mg/mL oral suspension from Tamiflu capsules in an emergency situation only if the commercially manufactured Tamiflu for oral suspension is unavailable.

For more information, please visit: Tamiflu
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