Summary of evidence and Expert Committee recommendations
During its meeting in 2003, the Committee recommended that long-acting nifedipine be reviewed for possible fast-track deletion at the meeting in 2005. A review was prepared by the WHO Collaborating Centre for Research and Training in Pharmaco-epidemiology in Barcelona, Spain, and comments were received from Médecins Sans Frontières.
The Committee noted that the presentation of nifedipine in the 13th Model List was slightly ambiguous and confirmed that only slow-release tablets of 10 mg were listed. The Committee also noted that short-acting nifedipine is not recommended in the treatment of hypertension due to its relative lack of safety when compared with other antihypertensive medicines. The review prepared by the Collaborating Centre identified that the clinical trial evidence showing benefits of dihydropyridine calcium-channel blockers was strongest for amlodipine.
On the basis of the review, the Committee recommended that sustained-release nifedipine be replaced with amlodipine (5 mg tablet) with a square box as the representative long-acting dihydropyridine calcium channel blocker. The Committee also recommended a review of the continued use of the square box at its next meeting.