The TGA is aware that there are currently some difficulties in obtaining supplies of methadone tablets, sold under the tradename Physeptone.
The shortage has arisen because recent batches of the tablets, manufactured by Sigma Pharmaceuticals, were withheld from the market because of quality control issues. The Therapeutic Goods Administration (TGA) has been working closely with the Sigma to resolve this problem and to minimise the impact on patients.
In order to ensure their safety and efficacy the affected Physeptone tablets require a lower storage temperature and have a shorter shelf life than previous stock. Sigma is currently relabelling and packaging these batches and has indicated that it expects to be able to recommence supply by 15 January 2010.
In the interim:
For patients with serious or life-threatening conditions prescribers may obtain the product directly from the sponsor, provided they notify the TGA within 28 days of use under Category A of the Special Access Scheme. Category A forms are available at: Special Access Scheme.
For patients with chronic pain that is not considered serious or life threatening, prescribers may obtain the product through Category B of the Special Access Scheme. Applications received by the TGA under Category B will be expedited until supplies return to normal. Category B forms are available at: Special Access Scheme
There is no problem with the production of sufficient quantities of the product in Australia and it has not been withdrawn from the market.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.