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Tamiflu Dosing Error Warning Issued by FDA

Sep 25, 2009 | Parker Waichman LLP

The U.S. Food & Drug Administration (FDA) has issued a Public Health Alert advising pharmacists and pediatrics healthcare professionals about potential dosing errors with Tamiflu (oseltamivir) for Oral Suspension.

The FDA stated that U.S. health care providers typically write prescriptions for liquid medicines in milliliters (mL) or teaspoons, while Tamiflu is dosed in milligrams (mg). The dosing dispenser packaged with Tamiflu has markings only in 30, 45, and 60 mg. The Agency has received reports of errors in which dosing instructions for the patient do not match that of the dosing dispenser.

The FDA is advising health care providers to indicate doses in mg if the dosing dispenser with the drug is in mg. Pharmacists should ensure that the units of measure on the prescription instructions match the dosing device provided with the drug.

In the United States, the FDA approved two antiviral drugs for treatment and prophylaxis of the 2009 H1N1 influenza virus: Tamiflu and Relenza (zanamivir). We recently wrote that medical authorities warned consumers to exercise caution when using these medications, citing the LA Times. Tamiflu and Relenza should be used when necessary and must be used appropriately.

The U.S. Centers for Disease Control and Prevention (CDC) describes the swine flu as a new virus first detected in the U.S. in April 2009 that is spreading from person-to-person worldwide, probably in much the same way that traditional seasonal influenza spreads. Earlier this year, the CDC said that the World Health Organization (WHO) indicated that a pandemic of the new H1N1 flu was underway.

Overuse or misuse of the drugs could pave the way for resistant strains of the emerging swine flu, which could make control of a pandemic all the more problematic, noted the LA Times, previously. Meanwhile, a Tamiflu-resistant strain of Swine Flu has already been reported.

The Public Health Alert, issued by the FDA, can be viewed at: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm183649.htm

The Dear Healthcare Professional Letter, issued by pharmaceutical maker, Roche, can be viewed at: http://www.fda.gov/downloads/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/UCM183752.pdf

The Information for Pharmacists, issued by the CDC, can be viewed at: http://www.cdc.gov/H1N1flu/pharmacist/pharmacist_info.htm.


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