Summary of evidence and Expert Committee recommendations
A review of EML section for antiparkinsonian medicines was considered by the Expert Committee in 2013.
Parkinson disease is prevalent the world over. Life expectancy for patients with Parkinson disease in Europe was shown to be severely limited before the introduction of levodopa. That is essentially the situation that still exists in resource-constrained settings such as sub-Saharan Africa.
The application reported that biperiden was not widely available. Anticholinergics as a class are now rarely used, except in younger patients with predominant tremor problems. Anticholinergic use in elderly patients and in patients with cognitive impairment is limited because of well-known side-effects, including confusion, dizziness, memory loss and psychosis (hallucinations and agitation). Hence, the application argued that retaining this medicine in the EML was not justified. Trihexphenidyl was reported to be more widely available and was therefore proposed for addition, with clear notes to indicate that it should be used only in younger patients.
The Expert Committee agreed to add a square box symbol to biperiden to allow for the option of procuring trihexyphenidyl.