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Abstract Details

Adverse drug reactions to apomorphine: a worldwide pharmacovigilance database analysis
Movement Disorders
P11 - Poster Session 11 (11:45 AM-12:45 PM)
5-008

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.

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

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.

9934 cases were identified within the study period (82,7% as of 2016). The United States account for the majority 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. 

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.

Authors/Disclosures
Manon Auffret, PhD, PharmD (Behavior & Basal Ganglia - CHU Rennes/ Universite de Rennes 1)
PRESENTER
Dr. Auffret has received personal compensation for serving as an employee of France Développement Electronique. The institution of Dr. Auffret has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Britannia. Dr. Auffret has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Aguettant. Dr. Auffret has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Britannia. Dr. Auffret has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Britannia. Dr. Auffret has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Aguettant. The institution of Dr. Auffret has received research support from Association France Parkinson. The institution of Dr. Auffret has received research support from Homeperf. The institution of Dr. Auffret has received research support from LVL. The institution of Dr. Auffret has received research support from University of Rennes. The institution of Dr. Auffret has received research support from Aguettant. The institution of Dr. Auffret has received research support from Linde. The institution of Dr. Auffret has received research support from Plateforme Nationale pour la recherche sur la fin de vie. Dr. Auffret has received publishing royalties from a publication relating to health care.
No disclosure on file
Marc Verin (CHU Hopital Pontchaillou) Mr. Verin has nothing to disclose.
No disclosure on file