Potential Medication Errors with Liquid Tamiflu

Starting date:

September 25, 2009

Posting date:

September 25, 2009

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety, Dosage

Audience:

General Public

Identification number:

RA-110003028

• Media enquiries
• Public enquiries

Health Canada is aware of an alert issued by the U.S. Food and Drug Administration (FDA) today regarding dosing errors associated with the liquid form of Tamiflu (the brand name for the drug oseltamivir) and is investigating the issue in Canada. Tamiflu is used in the treatment of influenza.

The FDA advisory stated that there have been cases where the label instructions for this product provided information in millilitres (mL) or teaspoons (tsp), while the measuring device provided with the prescription was in milligrams (mg). This led to patient or caregiver confusion and dosing errors.

In Canada and the United States, an oral dosing dispenser with 30 mg, 45 mg and 60 mg graduations is provided with the liquid form of Tamiflu. The recommended dosing instructions for adults and children are also provided in milligrams.

It is important for consumers to note that if the prescription instructions provided by a physician specify administration in milligrams, then the pharmacy should give dosing instructions in milligrams and provide the measuring device included in the Tamiflu product package.

If the physician's instructions specify administration in millilitres or teaspoons, then the measuring device included in the Tamiflu product package should be replaced, where possible, with one calibrated in millilitres or teaspoons. A pharmacist may also be able to convert the prescribing instructions back into milligrams.

Consumers who have questions about the proper use of this product should consult with their health care professional or pharmacist.

Health Canada will also be notifying health care professionals regarding this safety concern.

As of September 18, 2009, there had been no reports in Canada suggesting dosing error associated with the use of liquid Tamiflu. Health Canada will continue to closely monitor this issue.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada section of the Health Canada website
• Call toll-free at 1-866-234-2345
• Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to: Canada Vigilance Program
    Health Canada
    AL 0701C
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada section of the Health Canada website. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this section.

---

Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709