7 October 2021 Update:
We have included information about a second alternative overseas product approved for supply to address the discontinuation.
The Therapeutic Goods Administration (TGA) has authorised the supply of two alternative products to address the discontinuation of DILAUDID hydromorphone hydrochloride 1mg/mL oral liquid.
Hydromorphone hydrochloride preparations are indicated for the short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or otherwise inappropriate to provide sufficient management of pain.
DILAUDID hydromorphone hydrochloride 1mg/mL oral liquid (AUST R 67360) is the only registered hydromorphone hydrochloride oral liquid product marketed in Australia. The sponsor has advised the TGA this medicine has been discontinued as of 31 August 2021. Updated information provided by the company is available on the Medicine Shortage Reports Database.
Details of overseas alternative medicine
The alternative products, HYDROmorphone Hydrochloride 1mg/mL oral solution, USP 473 mL (Rhodes) (Rhodes HYDROmorphone), and HYDROMORPHONE HYDROCHLORIDE ORAL SOLUTION 1mg/mL USP 473mL (West-Ward) (West-Ward Hydromorphone) are usually only supplied overseas but have been approved for import and supply during the shortage.
IMPORTANT: ALLERGY WARNING
Rhodes HYDROmorphone and West-Ward Hydromorphone CONTAIN SULFITES
- Rhodes HYDROmorphone and West-Ward Hydromorphone contain sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
- Use of Rhodes HYDROmorphone and West-Ward Hydromorphone is contraindicated in patients with hypersensitivity to sulfites.
- Sulfites are not declared on the medicine label.
Information for health professionals
Medsurge Healthcare, the sponsor of Rhodes HYDROmorphone and Link Healthcare, the sponsor of West-Ward Hydromorphone, have distributed Dear Health Care Professional Letters that provides further information.
Information about the approvals of Rhodes HYDROmorphone and West-Ward Hydromorphone has been published in the TGA's online Section 19A database.
For further information or to arrange supply, health professionals should contact the relevant section 19A sponsor:
- Rhodes HYDROmorphone: Medsurge Healthcare ph:1300 788 261
- West-Ward Hydromorphone: Link Healthcare ph:1800 181 060
Rhodes HYDROmorphone and West-Ward Hydromorphone are contraindicated in patients with hypersensitivity to sulfites due to the presence of sodium metabisulfite. Sulfites are not declared on the medicine label.