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Availability of Tamiflu for Oral Suspension Overview

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Welcome to the Food and Drug Administration’s drug safety update.

I am Yolanda Fultz-Morris from F-D-A’s Center for Drug Evaluation and Research.

On December 11, 2009 we issued a public health advisory titled: Availability of Tamiflu for Oral Suspension.

FDA is informing healthcare professionals and consumers that additional quantities of the commercially prepared Tamiflu for Oral Suspension are being shipped to wholesalers and pharmacies. This new supply should address the current product shortage, although it will not immediately resolve shortages in all areas and availability of Tamiflu for Oral Suspension may be variable for some time.  Therefore, some pharmacists may still be required to prepare a compounded version of Tamiflu oral suspension from the 75 milligram capsules, as directed in the drug label, until adequate supplies are available.

FDA is also reminding healthcare professionals and consumers of important safety information regarding the safe and effective use of Tamiflu suspension.

  • The concentrations of the commercially available Tamiflu for Oral Suspension and the compounded Tamiflu oral suspension are different. The commercial Tamiflu for Oral Suspension has a concentration of 12 milligrams per milliliter, whereas the Tamiflu oral suspension that is compounded from the 75 milligram capsules has a concentration of 15 milligrams per milliliter. 
  • Ensure the dosing device dispensed with the product has markings that match the units of measure prescribed.  The dosing device that is packaged with Tamiflu for Oral Suspension is preferred because it provides the most accurate measurement of the commercially available suspension. However, this dosing device only has markings that measure 30, 45 and 60 milligram amounts. This has led to confusion because healthcare professionals generally prescribe liquid medications in volume amounts, in either milliliters or teaspoons, which are appropriately measured with an oral syringe calibrated in milliliters.

The following recommendations for consumers will help to ensure the safe use of Tamiflu Suspension:

  • Discuss with the pharmacists how much of and how often to give the medication.
  • Make sure a dosing device that can deliver the prescribed dose, either milligram or milliliter, is given to you when the medication is dispensed.
  • Ensure you understand how to use the dosing device that is given to you.
  • If the dosing device given to you with the medication is lost or misplaced, contact your pharmacist. Do not substitute a teaspoon or other measuring device.
  • Shake the bottle of Tamiflu for Oral Suspension or the compounded Tamiflu suspension before use.
  • Store the medication in the refrigerator.
  • Read the Tamiflu: Consumer Questions and Answers at F-D-A dot GOV slash D-R-U-G slash D-R-U-G S-A-F-E-T-Y slash P-O-S-T-M-A-R-K-E-T D-R-U-G-S-A-F-E-T-Y I-N-F-O-R-M-A-T-I-O-N for PatientsandProviders slash u-c-m-1-8-8-8-5-9 dot htm for additional information about the proper use of Tamiflu. 

 

To hear the full public health advisory, which includes FDA recommendations for health care professionals, listen to part two of this broadcast.

 

We urge healthcare providers and patients to report serious side effects that may be associated with the use of Tamiflu for Oral Suspension to us at the FDA’s MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot  F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

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