Important Safety Changes to Tamiflu

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 (graphic) 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.(Table 1) •Revised container labels ,carton packaging (graphic) •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. Additional Information for Patients •The concentration of Tamiflu for oral suspension is changing and you may get either concentration at your pharmacy during the next flu season. •The new Tamiflu for oral suspension container label and carton packaging look different from what you may have taken in the past. •The new oral dosing device is different and the volume (mL) of your dose may differ from past prescriptions. •Check with a healthcare professional if you have any questions about the dosing directions, how to measure a dose using the new dosing device, or about which concentration of Tamiflu for oral suspension you have. •Report any side effects you experience or medication errors to your healthcare professional and the FDA MedWatch program