Overseas products are temporarily approved for the 20mg dispersible tablets, but not on the PBS.
The TGA has announced alternatives to fluoxetine 20 mg dispersible tablets (Zactin Tabs, Alphapharm) which are expected to remain unavailable until 29 February 2024.
Fluoxetine has indications to treat major depression, obsessive-compulsive disorder and premenstrual dysphoric disorder.
Patients now have temporary access to two overseas fluoxetine 10 mg capsule products, but they are not on the PBS.
“These lower-strength capsule products can be used for patients taking a dose of less than 20 mg or a dose that cannot be made up using multiples of 20 mg,” says the TGA.
The Medicine Shortage Action Group has advised switching patients to the 20mg capsules where possible, and that capsule contents can be dispersed if need be. Pharmacists will be able to supply patients with capsules instead of dispersible tablets, but a new prescription is required for the patient to buy the capsules on the PBS. Patients can also be supplied with the 10mg capsules without needing a reissued prescription.
The shortage is due to the possible presence of an impurity – N-Nitrosofluoxetine – in the tablets, reported by the manufacturer.
The risk for patients, if the TGA investigation finds there is contamination, is only associated with long-term use and “is likely to be very low”, the TGA said in its safety advisory.
“N-Nitrosamine compounds (nitrosamines) are commonly found in water and food. We are all exposed to nitrosamines at differing levels. However, nitrosamine impurities may increase the risk of developing cancer, with the risk dependent on the level and length of exposure: higher levels over a short period of time can have an equivalent risk to lower levels for a longer period of time.”
“Stopping your medicine abruptly poses a greater and more immediate risk to health than potential low-level contamination with N-nitrosofluoxetine,” the TGA advises patients.
