FDA Drug Safety Communication: Tamiflu

Safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension

/ Author:  / Reviewed by: Joseph V. Madia, MD

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 and 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. 

Facts about Tamiflu

  • In a class of medications called neuraminidase inhibitors. These drugs work by stopping the spread of the influenza (flu) virus in the body.
  • Helps shorten the time you have flu symptoms such as a stuffy or runny nose, sore throat, cough, muscle or joint aches, tiredness, headache, fever, and chills.
  • Used to treat some types of flu in adults and children (older than 1 year of age) who have had symptoms for no longer than 2 days. It is also used to prevent some types of flu in adults and children (older than 1 year of age) when they have spent time with someone who has the flu or when there is a flu outbreak.

Genentech, the manufacturer of Tamiflu for oral suspension, plans to begin distribution of the new 6 mg/mL product in July 2011. 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 (see Additional Information sections below).

For complete background information on Tamiflu, please see Tamiflu (oseltamivir phosphate) Information.

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 using the information in the “Contact Us” box at the bottom of the page.  

Additional Background Information

FDA has worked with Genentech to make these important product safety changes to the Tamiflu for oral suspension product and to address the medication error-prone issues that FDA previously identified and communicated.

FDA issued a Public Health Alert in September 2009 regarding the potential for medication errors with the use of Tamiflu for oral suspension. The agency had received reports of errors where dosing instructions for the patient did not match the dosing dispenser. Additionally, the commercial Tamiflu for oral suspension concentration (12 mg/mL) was different from the concentration of the compounded suspension for emergency use (15 mg/mL when made from Tamiflu 75 mg capsules), which also may have contributed to confusion and medication errors.

FDA issued a Public Health Advisory in December 2009 on the availability of Tamiflu for oral suspension during an overall product shortage. Because the concentration of the marketed Tamiflu for oral suspension has changed to 6 mg/mL, the emergency compounding instructions that FDA provided in 2009 are now being updated to provide a final concentration of 6 mg/mL. This change will align the emergency-compounded final concentration with the new commercially-marketed oral suspension concentration of 6 mg/mL, which may reduce the potential for prescribing and dosing errors. FDA reiterates that this compounded suspension should not be used merely for convenience, or when the FDA-approved Tamiflu for oral suspension available.

Review Date: 
July 12, 2011