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FDA changes safety label of oseltamivir for oral suspension

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The concentration of the influenza drug oseltamivir (Tamiflu, Genentech) for oral suspension has been reduced from 12 mg/mL to 6 mg/mL as part of a product safety update conducted by the FDA.

The update was conducted to reduce the likelihood of prescribing and dosing problems that can lead to errors in medication. Genentech has participated in the process of making the changes.

The lower concentration of the drug is less likely to become frothy when shaken, according to an FDA press release. This will allow health care professionals to more accurately measure the dose. Other changes include:

• A change in the measurements of the oral dosing device from milligrams to milliliters.
• A change in the dosing table to include a column for the volume 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 capsules in an emergency situation only if the commercially manufactured drug for oral suspension is unavailable.

The company has begun distribution of the new product and has instituted a voluntary return program for wholesalers, distributors and pharmacies to remove the 12 mg/mL concentration from the market. The FDA encouraged participation in the return program but noted that no quality issues exist for the 12 mg/mL product.

The 12 mg/mL concentration will be taken off the market when supplies expire. The FDA noted that health care professionals should be aware that both concentrations will be on the market for some time and should be vigilant as the next influenza season approaches.

The packaging, dosing device and adverse events may change and patients should be notified of this if they are prescribed oseltamivir. However, pediatric doses have not changed.

Pharmacies are reminded that the return program extends until Aug. 13, 2011, that each prescription should contain a concentration and dose and that the unit of measurement matches the dosing device.

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