Orciprenaline sulphate (Alupent): reminder of withdrawal from the market
- Medicines and Healthcare products Regulatory Agency
- 1 July 2010
- Therapeutic area:
- Respiratory disease and allergy
Patients should be transferred to alternative bronchodilator therapy.
Article date: July 2010
Please ensure that patients are transferred to alternative bronchodilator therapy.
Orciprenaline sulphate (Alupent syrup), a non-specific β-agonist, was formerly licensed for reversible airway obstruction and suggested for maintenance therapy. It is to be withdrawn from the UK market on 30 September 2010. A comprehensive analysis of the available literature was completed last year, which showed that it was significantly less efficacious than other more-specific β2-agonists and was associated with a higher incidence of side effects.
The review concluded that the risk-benefit balance was unfavourable. Accordingly, the Commission on Human Medicines concluded that there:
- should be a planned withdrawal of orciprenaline sulphate from the UK market
- are no patient groups for whom transfer to a more-selective β2-agonist would be inappropriate
Orciprenaline sulphate will no longer be available after 30 September 2010. All patients who are currently receiving this medicine should be switched to a more-selective short-acting β2-agonist such as salbutamol or terbutaline as soon as possible.
Article citation: Drug Safety Update July 2010, vol 3 issue 12: 5a.
Published: 1 July 2010
Therapeutic area: Respiratory disease and allergy