Management of shortage of fluoxetine dispersible tablets (Australia)

Psychiatrists are advised about the current shortage of the antidepressant medicine, fluoxetine dispersible tablets (Zactin Tablet ®). This medicine, sponsored by Alphapharm Pty Ltd, is a restricted benefit under the Pharmaceutical Benefits Scheme (PBS) for major depressive disorders and obsessive-compulsive disorder.

The Therapeutic Goods Administration (TGA) has reported an ongoing shortage of Fluoxetine 20 mg tablet (Zactin®), initially listed on 8 November 2023 and expected to last until 29 February 2024, however the TGA expects this to continue further due to manufacturing reasons.

To help manage the shortage, the TGA has approved the supply of two overseas fluoxetine 10 mg capsule products temporarily under section 19A of the Therapeutic Goods Act 1989. 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. For further information please visit the TGA About the shortage of fluoxetine 20 mg dispersible tablets (Zactin Tabs) webpage which includes information for patients, carers and health professionals. 

The Pharmaceutical Benefits Advisory Committee (PBAC) has reviewed and recommended the temporary listing of alternatives on the PBS as outlined in the PBS statement of subsidy arrangement for fluoxetine

The RANZCP has been engaged with the work of the Medicine Shortage Action Group (MSAG) to enable these provisions to be made. 

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