Objective: To determine the safety profile of apomorphine (expected vs. new signals), regardless of the indication and route of administration.

Background: Adverse drug reactions (ADR) are an important cause of morbidity and mortality. Over the past 20 years, pharmacovigilance has played a major role in defining the safety profile of antiparkinsonian drugs under real-world conditions of use (e.g. sudden sleep attacks and levodopa, fulminant hepatitis and tolcapone, or valvular heart disease and pergolide). To date, no studies have been conducted on apomorphine, which is currently available for Parkinson’s disease (PD) in subcutaneous and sublingual forms.

Method: A general description of the data available worldwide was produced using the global pharmacovigilance database, VigiBase. ADR occurring  between 1976 and July 5, 2021 and for which apomorphine was suspected were extracted. VigiBase‘s signal detection tool was used to identify potential ADR not found in the drug product monograph.

Results: 9934 cases were identified within the study period (82,7% as of 2016). The United States account for most of the reports (35.5%). Overall, 34.7% of ADR were serious, including 4% of deaths. 76% were related to PD patients and 55,8% were reported for males. General disorders and administration site conditions (44,9%), nervous system disorders (34,1%) and gastrointestinal disorders (19,3%) were identified as expected. Emerging safety signals include respiratory, thoracic and mediastinal disorders (8,6%, e.g. rhinorrhea, hyperventilation), vascular (8,0%) and cardiac (2,5%) disorders (e.g. increased blood pressure & heart rate), eye disorders (1.8%, e.g. increased tearing), as well as renal and urinary disorders (1.4%, e.g. urinary urgency). Co-medications with other drugs (including levodopa, carbidopa, entacapone, trimethobenzamide, domperidone) are frequently observed and may contribute to such ADR.

Conclusion: As under-reporting is a known issue in pharmacovigilance, and more specifically among PD patients, these results warrant further investigations. Causality assessments are however needed to avoid unjustified flagging.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/adverse-drug-reactions-to-apomorphine-a-worldwide-pharmacovigilancedatabase-analysis/