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FDA Drug Safety Podcast for Healthcare Professionals: Important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension

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Welcome, my name is Jennifer Shepherd, a pharmacist in the Division of Drug Information. On July 11, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public of important product safety changes to the influenza drug Tamiflu, active ingredient 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 which measures weight, to milliliters which measures volume. 
  • A change in the dosing table for Tamiflu to include a column for the volume in milliliters 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.

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.  

At this time, FDA recommends that Healthcare Professionals be aware that:

  1. Prescribers should include the new concentration (6 mg/mL) and dose in milliliters on all prescriptions for Tamiflu for oral suspension. A revised dosing chart is included in the revised professional label.  
  2. Pediatric strength Tamiflu capsules are available as 30mg and 45mg capsules and have not changed. These capsules can be prescribed for pediatric patients who can swallow capsules. For patients who can not swallow capsules, these can be opened and the capsule contents can be mixed with flavored foods, such as chocolate syrup or caramel topping.
  3. The new 6 mg/mL product contains an oral dosing device graduated in mL, whereas the old 12 mg/mL product contained an oral dosing device with dose markings in mg.
  4. It is possible that patients may get either concentration at the pharmacy during the 2011-2012 flu season; patients should be educated about this possibility to avoid medication errors.
  5. The two versions of the professional label may appear in circulation during the 2011-2012 influenza season and contain different dosing and compounding instructions for the oral suspension. 
  6. Adverse events or medication errors involving Tamiflu should be reported to the FDA medwatch program at www.fda.gov/medwatch.

Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. Please read the Drug Safety Communication for important additional information for pharmacies, photos, tables, and background information detailing this communication. A link to this DSC can be found at www.fda.gov/Drugs/DrugSafety. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

 

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