Abstract:
Formulations of the same active pharmaceutical ingredients (API) may contain
a variety of inactive pharmaceutical ingredients (IPI) or excipients. Package
inserts are important sources of information to clinicians and should provide
details of both the API and the excipients in the pharmaceutical preparation.
The Medicine Control Council’s published guidelines recommend the inclusion of
excipients (qualitative) in the package insert, but this is not adequately
enforced. Excipient-related adverse drug reactions (ADR) are common in clinical
practice. Common adverse reactions caused by excipients are hyperactivity,
bronchoconstriction, skin eruptions, angio-oedema and gastrointestinal
symptoms. The management of patients with adverse drug reactions thus
requires critical observation and judgement of the history and symptomatology
of the patient in order to distinguish between an allergy and an intolerance in
the clinical situation. It is essential to establish whether it is an API or excipientrelated
ADR and the Cellular Antigen Stimulation Test (CAST) is recommended
as a first line laboratory test to perform in order to come to the correct
diagnosis. A clinical approach and guidelines are discussed and a clinical
rating scale was compiled by the author that will aid the clinician in the diagnosis
and management of excipient-related ADR.
