Orciprenaline sulphate (Alupent)

October 25 [Fri], 2019, 19:10
Orciprenaline sulphate (Alupent): withdrawal due to unfavourable benefit-risk profile



Orciprenaline sulphate is to be withdrawn over the next year because a review has concluded that the benefit-risk profile is unfavourable. Patients who require a liquid oral formulation of a β-agonist should be switched to a more-selective short-acting β2-agonist such as salbutamol or terbutaline.Orciprenaline sulphate powder

Orciprenaline sulphate (Alupent) is a non-specific β-agonist indicated for reversible airways obstruction and suggested for maintenance therapy. It is currently available for oral administration as a syrup.

An analysis of the available literature demonstrated that orciprenaline sulphate is significantly less efficacious than salbutamol in terms of both the extent and duration of bronchodilation. Yellow Card reports and clinical trial data show a significantly increased incidence of cardiac side effects, mainly palpitations and tachycardia because of its non-selectivity. Importantly, clinical trial data show that cardiac side effects occur before maximum bronchodilation is achieved because of its non-selectivity.

Accordingly, the Commission on Human Medicines (CHM) has advised that the balance of benefit and risks for orciprenaline sulphate is no longer favourable and concluded that:

there should be a planned withdrawal of orciprenaline sulphate from the UK market
there are no patient groups for whom transfer to a more-selective β2-agonist would be inappropriate
The MHRA is working with the manufacturer to achieve a planned voluntary withdrawal of orciprenaline sulphate over the next year. The product will continue to be available for several months, but it is recommended that patients are switched to a more-selective β2-agonist at the earliest opportunity.
コメントする
小文字 太字 斜体 下線 取り消し線 左寄せ 中央揃え 右寄せ テキストカラー 絵文字 プレビューON/OFF

不正な自動コメント投稿を防ぐため、チェックボックスにチェックをしてください。

利用規約に同意
 X 
禁止事項とご注意
※本名・メールアドレス・住所・電話番号など、個人が特定できる情報の入力は行わないでください。
「ヤプログ!利用規約 第9条 禁止事項」に該当するコメントは禁止します。
「ヤプログ!利用規約」に同意の上、コメントを送信してください。