Recommended Citation
Adimi N, Berber L, Foy O, Ehrenpreis E. Medications for Gastroparesis and the Development of Tardive Dyskinesia: A Review of the FDA Adverse Event Reporting System (FAERS). Presented at Scientific Day; May 21, 2025; Park Ridge, IL.
Abstract
Background/Significance:
Tardive dyskinesia (TD) is a movement disorder characterized by involuntary, repetitive movements, frequently involving the face and limbs. A variety of medications are associated with the development of TD, including those used for the treatment of gastroparesis. Metoclopramide has a black box warning from the FDA for TD. In this study, medications used to treat gastroparesis were evaluated for their likelihood of causing the adverse drug reaction (ADR) of TD based on reports to the FAERS database.
Purpose:
Tardive dyskinesia can be an irreversible condition that is debilitating to patients. It is important to understand that some medications that are commonly used to treat gastroparesis can have this side effect and possibly shift focus to other medications that are less likely to cause this.
Methods:
FAERS is a collection of voluntarily reported adverse reactions used for post-marketing surveillance of medications. A total of 29,661,136 FAERS reports from Jan 1968 to Dec 2024 were reviewed. Reports for 15 medications used to treat gastroparesis were included for analysis. Filtering of duplicate reports and data analysis were performed using the Open Vigil program. The reporter odds ratio (ROR) was measured to determine the likelihood that the medication was associated with TD and determine the likelihood of a signal for an adverse drug reaction (ADR). The formula for ROR is as follows: ROR = (a/c)/(b/d), a: drug with the specific ADR, b: all drugs with the specific ADR, c: all ADRs of the specific drug, d: all other drugs with other ADRs).
Results:
Three medications, domperidone, granisetron, and cyclizine had too few reports to analyze using this method. Of the others, an extremely elevated risk of TD was seen with metoclopramide (ROR=499, CI 486-512). Other medications demonstrating signals for TD included promethazine (ROR=3.14, CI 2.75-3.59), mirtazapine (ROR=2.98, CI 2.68-3.32), lorazepam (ROR=2.12, CI 1.94-2.32), erythromycin (ROR=1.89 CI1.43-2.51), nortriptyline (ROR=1.86, CI 1.08-3.20), and alprazolam (ROR=1.20 CI 1.08-1.33).
Discussion:
A number of medications used to treat gastroparesis demonstrate signals for TD. The risk for TD with the use of metoclopramide is once again demonstrated to be extremely high, emphasizing its avoidance as extended use and prescription in high-risk groups (elderly persons, women, and diabetic patients). Clinicians should warn patients of the risk of TD when prescribing these medications associated with TD.
Presentation Notes
Presented at Scientific Day; May 21, 2025; Park Ridge, IL.
Full Text of Presentation
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Document Type
Oral/Podium Presentation
Medications for Gastroparesis and the Development of Tardive Dyskinesia: A Review of the FDA Adverse Event Reporting System (FAERS)
Background/Significance:
Tardive dyskinesia (TD) is a movement disorder characterized by involuntary, repetitive movements, frequently involving the face and limbs. A variety of medications are associated with the development of TD, including those used for the treatment of gastroparesis. Metoclopramide has a black box warning from the FDA for TD. In this study, medications used to treat gastroparesis were evaluated for their likelihood of causing the adverse drug reaction (ADR) of TD based on reports to the FAERS database.
Purpose:
Tardive dyskinesia can be an irreversible condition that is debilitating to patients. It is important to understand that some medications that are commonly used to treat gastroparesis can have this side effect and possibly shift focus to other medications that are less likely to cause this.
Methods:
FAERS is a collection of voluntarily reported adverse reactions used for post-marketing surveillance of medications. A total of 29,661,136 FAERS reports from Jan 1968 to Dec 2024 were reviewed. Reports for 15 medications used to treat gastroparesis were included for analysis. Filtering of duplicate reports and data analysis were performed using the Open Vigil program. The reporter odds ratio (ROR) was measured to determine the likelihood that the medication was associated with TD and determine the likelihood of a signal for an adverse drug reaction (ADR). The formula for ROR is as follows: ROR = (a/c)/(b/d), a: drug with the specific ADR, b: all drugs with the specific ADR, c: all ADRs of the specific drug, d: all other drugs with other ADRs).
Results:
Three medications, domperidone, granisetron, and cyclizine had too few reports to analyze using this method. Of the others, an extremely elevated risk of TD was seen with metoclopramide (ROR=499, CI 486-512). Other medications demonstrating signals for TD included promethazine (ROR=3.14, CI 2.75-3.59), mirtazapine (ROR=2.98, CI 2.68-3.32), lorazepam (ROR=2.12, CI 1.94-2.32), erythromycin (ROR=1.89 CI1.43-2.51), nortriptyline (ROR=1.86, CI 1.08-3.20), and alprazolam (ROR=1.20 CI 1.08-1.33).
Discussion:
A number of medications used to treat gastroparesis demonstrate signals for TD. The risk for TD with the use of metoclopramide is once again demonstrated to be extremely high, emphasizing its avoidance as extended use and prescription in high-risk groups (elderly persons, women, and diabetic patients). Clinicians should warn patients of the risk of TD when prescribing these medications associated with TD.
Affiliations
Advocate Lutheran General Hospital