Oral Flu Drug Product Changed to Reduce Medication Errors

Oral Flu Drug Product Changed to Reduce Medication ErrorsThe U.S. Food and Drug Administration has issued a warning to the public regarding safety changes in Tamiflu (oseltamivir phosphate), an oral suspension influenza drug. Changes are being made to reduce the risk of medication errors and to eliminate prescription and dosing confusion.

The manufacturer of the medication, Genentech, has worked with the FDA to create these changes, which include dosage and product label alterations. The changes come as a result of public health alerts issued by the FDA in September 2009 after the agency received a number of complaints that dosing instructions did not match the dispenser.

Tamiflu is known as a neuraminidase inhibitor, meaning it stops the spread of the flu virus in the body. Flu symptoms like stuffy or runny noses, sore throats, coughs, muscle aches and fevers are shortened thanks to the medication.

The medication has been changed from 12 milliliters to a lower concentration of 6 milliliters in order to reduce its frothiness when shaken. When the mixture becomes frothy, dosages can be inadvertently altered due to inaccurate measurements. Once the current offerings on the shelves of the 12 ml concentrations run out, this larger bottle will no longer be available.

Also to avoid confusion, Tamiflu has changed its label from milligrams to milliliters, shifting to a measurement of volume rather than weight.

The FDA is assuring the public that the Tamiflu in the larger container is still safe to use until the supply's expiration date, but product confusion could exist during the change-over, leading to inaccurate dosing. To lower the likelihood of this occurrence, the FDA is encouraging retailers, pharmacies and distributors to participate in the Take Back Program.

Patients should be aware that although the FDA and Genentech have facilitated the change, they could receive either concentration from their pharmacist. For the next flu season, the labeling and packaging of Tamiflu will look different than in previous years, but the drug is still the same.

The FDA asks patients to report any side effects or medication errors to a healthcare professional.

According to Tamiflu, the medication should be taken twice daily for five days or as a preventative measure once daily for 10 days after exposure or for up to six weeks during a community outbreak of the flu. Tamiflu can be taken with or without food, but eating while taking the drug can lessen side effects in some patients.

Common side effects of Tamiflu including nausea and vomiting, and these complications are usually mild to moderate, typically occurring in the first two days of treatment.